Value through Innovation27 July 2016

Clinical Study Results

  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2502
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Postmarketing surveillance (as per § 67 (6) AMG [German Drug Law]) of Atrovent® inhalets in Chronic Obstructive Pulmonary Disease

    Study Document Trial synopsis 244.2502_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2507
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    ATROVENT HFA open-label Actuation Indicator evaluation and handling study in Adults with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 244.2507_DS_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2496
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (as per § 67 (6) AMG [German Drug Law]) of Atrovent® in long-term therapy in Chronic Obstructive Pulmonary Disease

    Study Document Trial synopsis 244.2496_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2500
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance study (as per § 67 (6) AMG [German Drug Law]) of Atrovent® 500 µg/2 ml inhalation solution in Chronic Obstructive Pulmonary Disease

    Study Document Trial synopsis 244.2500_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2501
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (as per § 67 (6) AMG [German Drug Law]) of Atrovent® inhalets in Chronic Obstructive Pulmonary Disease

    Study Document Trial synopsis 244.2501_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2480
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    An Open-Label, Crossover, Pharmacokinetic Trial to Determine the Comparability of 84 mcg Ipratropium Bromide HFA-134a Inhalation Aerosol to 84 mcg ATROVENT® CFC  Inhalation Aerosol, in Patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 244.2480_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2484
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A six month, double-blind (within formulation), randomized, multiple dose trial to compare the safety and efficacy of 20 mcg and 40 mcg of ipratropium bromide, as delivered by the Respimat® device, to 18 mcg ATROVENT® Inhalation Aerosol (x 2 puffs) and respective placebos in adults, with chronic obstructive pulmonary disease

    Study Document Trial synopsis 244.2484 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2489
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A Double-Blind, Placebo Controlled Trial to Assess the Safety of Two-Week Administration of 80 Mcg Q.I.D. and 160 Mcg Q.I.D. of Ipratropium Bromide, as Delivered by the RESPIMAT® Device, in Patients with Chronic Obstructive Pulmonary Disease

    Study Document Trial synopsis 244.2489_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2491
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Postmarketing surveillance study (as per§ 67 (6) AMG [German Drug Law]) of Atrovent® Inhaletten® in chronic obstructive airways disease

    Study Document Trial synopsis 244.2491 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2492
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Postmarketing surveillance study (as per§ 67 (6) AMG [German Drug Law]) of Atrovent® Inhaletten® in chronic obstructive airways disease

    Study Document Trial synopsis 244.2492 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2493
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Postmarketing surveillance study (as per§ 67 (6) AMG [German Drug Law]) of Atrovent® unit dose vial 500 mvg in chronic obstructive airways disease

    Study Document Trial synopsis 244.2493 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2497
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (in accordance with § 67 (6) AMG) of Atrovent® inhalets in Chronic Obstructive Pulmonary Disease

    Study Document Trial synopsis 244.2497 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2498
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A Single-Dose, Double Blind, Crossover Trial to Determine the Comparability of Ipratropium Bromide HFA-134a Inhalation Aerosol to the Market Standard, ATROVENT® CFC Inhalation Aerosol, in Patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 244.2498_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2499
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (in accordance with § 67 (6) AMG) of anticholinergics -prescribing pattern and therapeutic long-term value in patients suffering from moderate or severe Chronic Obstructive Pulmonary Disease

    Study Document Trial synopsis 244.2499 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2514
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Peri-operative intervention with nebulized ipratropium bromide in Chinese patients with chronic obstructive pulmonary disease (COPD): a randomised, double-blind, placebo-controlled, parallel-group, multicentre trial

    Study Document Trial synopsis 244.2514_DR english
  • Amelubant - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 543.10
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase IIa
    Study Title

    Effect of 14-Day Treatment with BIIL 284 BS on Patients with COPD (Double-Blind, Placebo-Controlled, Randomised, Parallel Group Study)

    Study Document Trial synopsis 543.10_CO english
  • Amelubant - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 543.17
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase IIa
    Study Title

    Effect of 12-week treatment of 5, 25 or 75 mg BIIL 284 BS on exercise endurance in patients with chronic obstructive pulmonary disease (double-blind, double dummy, placebo-controlled, randomized, parallel group, dose ranging study)

    Study Document Trial synopsis 543.17 english
  • BEA 2180 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1205.3
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase IIa
    Study Title

    Randomised, Double-Blind, Placebo-Controlled, 4-Way Cross-Over Study to Assess the Efficacy and Safety of a Single Dose of Orally Inhaled BEA 2180 BR (doses 80, 200 and 800 µg) in COPD Patients Followed by an Open-Label, Active-Control (tiotropium 72 µg)

    Study Document Trial synopsis 1205.3_CO english
  • BEA 2180 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1205.14
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase IIb
    Study Title

    A multinational, randomized, double-blind, placebo- and active-controlled, parallel group efficacy and safety comparison over 24 weeks of three doses (50 µg , 100 µg, 200 µg) of BEA 2180 to tiotropium 5 µg and placebo deliveredby the Respimat® inhaler in patients with chronic obstructive pulmonary disease (COPD)

    Study Document Trial synopsis 1205.14_DR english Pooled analysis 1205.14_DR english
  • BEA 2180 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1205.4
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomized, multiple-dose, double-blind, placebo- and active controlled, parallel group efficacy and safety study to determine the optimum dose of BEA 2180 BR delivered by the Respimat® inhaler in patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1205.4_DR english
  • BEA 2180 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1205.6
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase IIb
    Study Title

    A Randomized, Multiple-dose, Double-Blind, Crossover Study to Compare the Efficacy and Safety of 200 µg and 400 µg of BEA 2180 BR to Tiotropium 5 µg and Placebo When Each is Delivered by the Respimat® Inhaler in Patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1205.6_DR english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1365
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised open label, four way, cross-over scintigraphic evaluation of the Respimat® inhaler vs. a Metered Dose Inhaler (HFA-MDI) using Berodual® in patients with Chronic Obstructive Pulmonary disease (COPD) with poor MDI technique.

    Study Document Trial synopsis 215.1365_CO english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1364
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised open label, six way, cross-over scintigraphic evaluation of the effect of inspiratory flow rate on lung and oropharyngeal deposition with the Respimat® inhaler vs. a Metered Dose Inhaler (HFA-MDI) using Berodual® in patients with Chronic Obstructive Pulmonary disease (COPD).

    Study Document Trial synopsis 215.1364 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1349
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, placebo-controlled, within-device, double-blind tri-national study to compare the safety and efficacy of Berodual® administered via the Respimat® device (50 mcg fenoterol hydrobromide/20 mcg ipratropium bromide and 25 mcg fenoterol hydrobromide/10mcg ipratropium bromide, 1 puff q.i.d.) with that administered via the MDI (50 mcg fenoterol hydrobromide/21 mcg ipratropium bromide, 2 puffs q.i.d..) in COPD patients over a 12-week period.

    Study Document Trial synopsis 215.1349 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1352
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Postrnarketing surveillance study (as per§ 67 (6) AMG [German DrugLaw]) of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease

    Study Document Trial synopsis 215.1352 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1353
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (in accordance with§ 67,6 AMG) of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease

    Study Document Trial synopsis 215.1353 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1357
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    Berodual® Respimat® Inhaler (20g ipratropium bromide/50g fenoterol hydrobromide, 1 actuation t.i.d./q.i.d.) versus Berodual® MA using HFA 134a as propellant (20g ipratropium bromide (anhydrous)/50g fenoterol hydrobromide, 2 puffs t.i.d./q.i.d.) in adult patients with asthma, chronic obstructive pulmonary disease, or mixed conditions, an open-label, crossover trial over a 7-week treatment period with each formulation:"A Study To Compare Patient Preference"

    Study Document Trial synopsis 215.1357_CO english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1358
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (in accordance with § 67 (6) AMG) of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease

    Study Document Trial synopsis 215.1358 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1360
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IIIb/IV
    Study Title

    A randomised open label, four way, cross-over scintigraphic evaluation of the Respimat® inhaler vs a Metered Dose Inhaler (HFA-MDI) using Berodual® in patients with Chronic Obstructive Pulmonary Disease(COPD) with poor MDI technique

    Study Document Trial synopsis 215.1360_CO english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1361
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IIIb/IV
    Study Title

    A randomised open label, six way, cross-over scintigraphic evaluation of the effect of inspiratory flow rate on lung and oropharyngealde position with the Respimat® inhaler vs a Metered Dose Inhaler (HFA-MDI) using Berodual® in patients with Chronic ObstructivePulmonary Disease (COPD)

    Study Document Trial synopsis 215.1361_CO english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1362
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Berodual® Respimat® 20/50 mcg/dose solution for inhalation in patients with chronic obstructive airways disease

    Study Document Trial synopsis 215.1362 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1363
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease

    Study Document Trial synopsis 215.1363 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1366
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Berodual® Respimat® 20/50 mcg/dose solution for inhalation: Assessment of handling and patient satifaction in comparison to a powder inhaler

    Study Document Trial synopsis 215.1366 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1367
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Berodual® Respimat® 20/50 mcg/dose solution for inhalation: Assessment of handling and patient satifaction

    Study Document Trial synopsis 215.1367 english
  • BEROTEC ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 260.3178
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BEROTEC ®
    Generic Name Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Postmarketing surveillance study (as per§ 67 (6) AMG [German Drug Law]) of Berotec® N 100 mcg meterd-dose inhaler in chronic obstructive airways disease

    Study Document Trial synopsis 260.3178 english
  • BIBW 2948 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1219.5
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BIBW 2948
    Generic Name BIBW 2948
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomized, double-blind, placebo-controlled, parallel group study to evaluate the effects of a 4-week treatment of 15 and 30 mg b.i.d BIBW 2948 BS (inhalation powder, hard capsule for HandiHaler®) on epithelial mucin stores and the safety and efficacy in COPD patients with symptoms associated with chronic bronchitis

    Study Document Trial synopsis 1219.5 english
  • BIBW 2948 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1219.4
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BIBW 2948
    Generic Name BIBW 2948
    Lab Code
    Clinical Phase IIa
    Study Title

    A phase II, randomised, double-blind, placebo-controlled and parallel group study to evaluate the safety and efficacy of four weeks treatment of 7.5 mg b.i.d, 15 mg q.d and 15 mg b.i.d. BIBW 2948 BS (inhalation powder, hard capsule for HandiHaler®) in patients with COPD associated with chronic bronchitis.

    Study Document Trial statement 1219.4_DR english
  • COMBIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1012.46
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase III
    Study Title

    A comparison of ipratropium bromide/salbutamol delivered by the Respimat® inhaler to ipratropium bromide Respimat®, COMBIVENT® Inhalation Aerosol and Placebo of each formulation in a 12-week, double-blind, safety and efficacy study in adults with chronic obstructive pulmonary disease.

    Study Document Trial Supplement and Synopsis 1012.46_CO english
  • COMBIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1012.56
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase III
    Study Title

    A comparison of ipratropium bromide/salbutamol delivered by the Respimat® inhaler to Combivent® Inhalation Aerosol and ipratropium bromide delivered by the Respimat® in a 12-week, double-blind, safety and efficacy study in adults with chronic obstructive pulmonary disease

    Study Document Trial synopsis 1012.56 english
  • COMBIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1012.62
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase IIIb
    Study Title

    Phase III, one-year, randomized, open-label safety and patient acceptability study of Combivent® Respimat® (ipratropium bromide and albuterol sulfate) (20/100 mcg) Inhalation Spray in comparison to Combivent® Inhalation Aerosol  (36/206 mcg) and the free combination of Atrovent® HFA (ipratropium bromide  HFA) inhalation Aerosol (34 mcg) and albuterol HFA inhalation aerosol (180 mcg) in adults with chronic obstructive pulmonary disease (COPD)

    Study Document Trial synopsis 1012.62_DS_CO english
  • COMBIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1012.11
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase III
    Study Title

    A one-year randomized, double-blind, placebo and active-controlled parallel design safety and efficacy comparison of COMBIVENT HFA Inhalation Aerosol to COMBIVENT® (CFC) Inhalation Aerosol in patients with COPD

    Study Document Trial synopsis 1012.11 english
  • COMBIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1012.25
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase IIb
    Study Title

    A Randomized, Double-Blind, Crossover, Placebo- and Active-Controlled Dose-Confirmation Study of COMBIVENT HFA Inhalation Aerosol in Patients with COPD

    Study Document Trial synopsis 1012.25 english
  • COMBIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1012.39
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised, double-blind, active-controlled, within-patient trial comparing the effects of single doses of nebulised ipratropium 500 mcg, salbutamol sulphate 3mg, salbutamol sulphate 6mg, and the combination therapy salbutamol sulphate 3mg plus ipratropium 500 mcg (Combivent® UDVs®) on arterial oxygen saturation in patients with stable, moderate to severe chronic obstructive pulmonary disease.

    Study Document Trial synopsi 1012.39_CO english
  • COMBIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1012.43
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase IIb
    Study Title

    Safety assessment of cumulative doses of Combivent® HFA-propelled metered dose inhaler in comparison to Combivent ® CFC-propelled metered dose inhaler A randomised, double-blind, active-controlled, two-way cross-over study in COPD patients

    Study Document Trial synopsis 1012.43 english
  • COMBIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1012.65
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase IV
    Study Title

    Open label, non-randomised, 1-day trial to characterize the performance of two adapter devices designed to permit use of the Respimat® inhaler device with patients requiring mechanical ventilation

    Study Document Trial synopsis 1012.65 english
  • OXIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 54.560
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product OXIVENT ®
    Generic Name Oxitropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A phase III study of Ba253BINEB in patients with COPD. Double blind, randomised, double dummy, multiple dose study in comparison with MDI.

    Study Document Trial synopsis 54.560 english
  • OXIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 54.561
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product OXIVENT ®
    Generic Name Oxitropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A phase III long-term study of Ba253BINEB in patients with COPD.

    Study Document Trial synopsis 54.561 english
  • OXIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 54.563
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product OXIVENT ®
    Generic Name Oxitropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (in accordance with§ 67 (6) AMG) of Ventilat® in Chronic Obstructive Pulmonary Disease

    Study Document Trial synopsis 54.563 english
  • OXIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 54.564
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product OXIVENT ®
    Generic Name Oxitropium bromide
    Lab Code
    Clinical Phase Iv
    Study Title

    Postmarketing surveillance study (as per§ 67 (6) AMG[German Drug Law]) of Ventilat® metered-dose inhaler in chronic obstructive bronchitis

    Study Document Trial synopsis 54.564 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.3
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, 3-way crossover study to compare pharmacokinetics and safety of 10 mcg BI 1744 CL plus 5 mcg tiotropium bromide given as fixed dose combination via the Respimat Inhaler with the pharmacokinetics and the safety of the single agents, i.e., 10 mcg BI 1744 CL and 5 mcg tiotropium bromide, delivered via the Respimat Inhaler, following 21-day treatment periods in patients with chronic obstructive pulmonary disease (COPD)

    Study Document Trial synopsis 1237.3 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.5
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIIa
    Study Title

    A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 µg / 5 µg; 5 µg / 5 µg) (delivered by the Respimat® Inhaler) compared with the individual components (2.5 µg and 5 µg tiotropium, 5 µg olodaterol) (delivered by the Respimat® Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD). [TOnado TM 1].  Combined analysis of efficacy data obtained in the replicate studies 1237.5 and 1237.6

    Study Document Trial synopsis 1237.5_DR english Combined analysis of 1237.5 and 1237.6_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.6
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 µg / 5 µg; 5 µg / 5 µg) (delivered by the Respimat® Inhaler) compared with the individual components (2.5 µg and 5 µg tiotropium, 5 µg olodaterol) (delivered by the Respimat® Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD) [TOnado TM 2].  Combined analysis of efficacy data obtained in the replicate studies 1237.5 and 1237.6

    Study Document Trial synopsis 1237.6_DR english Combined analysis of 1237.5 and 1237.6_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.9
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIb
    Study Title

    Randomised, double-blind, cross-over study to assess the efficacy and safety of   4 weeks of once daily treatment of 2 doses of orally inhaled BI 1744 CL, each in fixed dose combination (FDC) with 5 µg tiotropium bromide (delivered by the respimat® inhaler) in patients with COPD

    Study Document Trial synopsis 1237.9_DS_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.4
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIb
    Study Title

    Randomised, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of 3 Doses of Orally Inhaled BI 1744 CL, each in fixed dose combination with 5 µg Tiotropium Bromide (Delivered by the Respimat® Inhaler) compared with 5µg Tiotropium Bromide Monoproduct (Delivered by the Respimat® Inhaler) in Patients with COPD

    Study Document Trial synopsis 1237.4_DS_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.18
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study to determine the optimal free dose combination of olodaterol and tiotropium (both delivered by the Respimat® Inhaler) after 4 weeks once daily treatment in patients with COPD

    Study Document Trial synopsis 1237.18_DS_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.24
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase Ib
    Study Title

    A randomised, open-label, parallel-group trial to assess pharmacokinetics and safety of tiotropium + olodaterol fixed-dose combination (2.5 µg/ 5 µg, 5 µg/ 5 µg) delivered by the RESPIMAT inhaler after 3 weeks once daily treatment in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1237.24 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.13
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, 5 treatment arms, 4-period, incomplete cross-over study to determine the effect of 6 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (FDC) (2.5 / 5 µg and 5 / 5 µg) (delivered by the Respimat® Inhaler) compared with tiotropium (5 µg), olodaterol (5 µg ), and placebo (delivered by the Respimat® Inhaler) on lung hyperinflation and exercise endurance time during constant work rate cycle ergometry in patients with Chronic Obstructive Pulmonary Disease (COPD) [MORACTO™ 1]

    Study Document Trial synopsis 1237.13_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.14
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, 5 treatment arms, 4-period, incomplete cross-over study to determine the effect of 6 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (FDC) (2.5 / 5 µg and 5 / 5 µg) (delivered by the Respimat® Inhaler) compared with tiotropium (5 µg), olodaterol (5 µg ), and placebo (delivered by the Respimat® Inhaler) on lung hyperinflation and exercise endurance time during constant work rate cycle ergometry in patients with Chronic Obstructive Pulmonary Disease (COPD) [MORACTO™ 2]

    Study Document Trial synopsis 1237.14_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.15
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled, parallel group study to determine the effect of 12 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg, 5/5 µg) delivered by the Respimat® Inhaler, on exercise endurance time during constant work rate cycle ergometry inpatients with Chronic Obstructive Pulmonary Disease (COPD) [TorractoTM]

    Study Document Trial synopsis 1237.15_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.20
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    Randomised, double-blind, placebo-controlled, 6 treatment, 4 period, incomplete cross-over trial to characterise the 24-hour lung function profiles of tiotropium + olodaterol fixed dose combination (2.5/5 µg, 5/5 µg), tiotropium (2.5 µg, 5 µg) and olodaterol (5 µg) (oral inhalation, delivered by the Respimat® Inhaler) after 6 weeks once daily treatment in patients with Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM]

    Study Document Trial synopsis 1237.20_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.22
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, parallel-group study to assess the safety and efficacy of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed-dose combination (2.5 µg/ 5 µg, 5 µg/ 5 µg) and olodaterol (5 µg) delivered by the Respimat® inhaler in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1237.22_DS_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.7
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase II
    Study Title

    A randomised, placebo-controlled, double-blind, single dose, cross-over trial to evaluate the efficacy and safety of orally inhaled tiotropium + olodaterol as both a fixed dose combination and a free combination (both delivered by the RESPIMAT® inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1237.7_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.25
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double-blind, placebo- and active-controlled parallel group study to assess the efficacy of 12 weeks of once daily treatment of two doses of orally inhaled tiotropium + olodaterol fixed dose combination (delivered by the Respimat® inhaler) in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) [OTEMTO™1]

    Study Document Trial synopsis 1237.25_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.26
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double-blind, placebo- and active-controlled parallel group study to assess the efficacy of 12 weeks of once daily treatment of two doses of orally inhaled tiotropium + olodaterol fixed dose combination (delivered by the Respimat® inhaler) in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) [OTEMTO™2]

    Study Document Trial synopsis 1237.26_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.11
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    Randomized, double-blind, double-dummy, active-controlled, 4 period complete cross-over study to compare the effect on lung function of 6 weeks once daily treatment with orally inhaled tiotropium+olodaterol fixed dose combination delivered by the Respimat® inhaler vs. 6 weeks twice daily treatment with fluticasone propionate+salmeterol fixed dose combination delivered by the Accuhaler® in patients with Chronic Obstructive Pulmonary Disease (COPD

    Study Document Trial synopsis 1237.11_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.16
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    An exploratory, 12 week, randomised, partially double-blinded, placebo-controlled parallel group trial to explore the effects of once daily treatments of orally inhaled tiotropium + olodaterol fixed dose combination or tiotropium (both delivered by Respimat® inhaler), supervised exercise training and behavior modification on exercise capacity and physical activity in patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1237.16_CO english Lay summary 1237.16 english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.215
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    Effect of a 12-week treatment with inhaled tiotropium (18 mcg once daily) on lung function and static lung volumes in stable, moderate to severe COPD patients. Correlation to dyspnoea scales. A double-blind, placebo-controlled, randomized, parallel group study

    Study Document Trial synopsis 205.215_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.220
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A single-blind two-centre trial to compare administration technique, learning retention of the administration technique and ease of use of the HandiHaler® with those of the pressurised metered dose inhaler (MDI) in patients with COPD.

    Study Document Trial synopsis 205.220_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.223
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    Effect of tiotropium on exercise tolerance and static and dynamic lung volumes in COPD patients (a randomized, double-blind, placebo controlled, parallel group study)

    Study Document Trial synopsis 205.223_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.226
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A randomized, double-blind, placebo-controlled, parallel group trial assessing the proportion of patients experiencing an exacerbation and proportion of patients hospitalized for an exacerbation over 6 months during treatment with tiotropium 18 mcg capsule once daily in patients with COPD in a Veterans Affairs setting

    Study Document Trial synopsis 205.226_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.227
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A Multiple Dose Comparison of Tiotropium 18 µg Inhalation Capsules and Oxitropium MDI (2 puffs of 100 µg) in a One-year, Open-Label, Safety and Efficacy Study in Patients with COPD

    Study Document Trial synopsis 205.227_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.230
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomized, double-blind, placebo-controlled 25-week trial to compare the effect of Tiotropium Inhalation Capsules (18 mcg) once daily on exercise tolerance in patients with chronic obstructive pulmonary disease (COPD) participating in 8 weeks of pulmonary rehabilitation.

    Study Document Trial synopsis 205.230_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.231
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    Randomized, double-blind, placebo-controlled, cross-over study to examine the effects of tiotropium on lung hyperinflation, respiratory mechanics and dyspnea during exercise in patients with COPD

    Study Document Trial synopsis 205.231_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.234
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A comparison of the effects of Tiotropium (18 mcg) Inhalation Capsule q.d. and Salmeterol (50 mcg) Inhalation Aerosol b.i.d. on arterial blood gases in a double-blind, double-dummy, 4-week crossover study in patients with chronic obstructive pulmonary disease (COPD).

    Study Document Trial synopsis 205.234_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.238
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    Gamma-Scintigraphic Evaluation of the Lung Deposition Rate and Distribution Pattern of a 99mTc-Labelled Tiotropium Powder Formulation Following Multiple Dose Inhalation of Tiotropium via HandiHaler(TM) in Healthy Subjects and Patients with COPD

    Study Document Trial synopsis 205.238_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.235
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomized, double-blind, placebo-controlled, parallel group trial assessing the rate of decline of lung function with tiotropium 18 mcg inhalation capsule once daily in patients with chronic obstructive pulmonary disease (COPD)

    Study Document Trial synopsis 205.235_DS_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.254
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    1. A Randomised, Double-Blind Placebo Controlled, Parallel Group Efficacy and Safety Comparison of One-year Treatment of Two Doses (5 µg [2 actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg]) of Tiotropium Inhalation Solution Delivered by the Respimat® Inhaler in Patients with Chronic Obstructive Pulmonary Disease (COPD) 2. Pooled Analysis: Tiotropium (SPIRIVA®) RESPIMAT®: Evaluation of Fatal Events – February 2010 3. A Combined Analysis of Efficacy and Safety Data obtained in Studies 205.254and 205.255 – Two Randomised, double-blind, efficacy and safety comparisonsof one year treatment of two doses (5µg [2 actuations of 2.5µg] and (10µg [2actuations of 5µg] of Tiotropium Inhalation Solution Delivered by theRespimat® Inhaler in Patients with Chronic Obstructive Pulmonary Disease(COPD)

    Study Document Trial synopsis 205.254_DS_CO english Pooled analysis 205.254_DR english Combined analysis of 205.254 and 205.255_DS_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.255
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    1. A Randomised, Double-Blind, Placebo-controlled, Parallel Group Efficacy and Safety Comparison of one-year Treatment of Two Doses (5 µg [2 actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg]) of Tiotropium Inhalation Solution Delivered by the Respimat® Inhaler in Patients with Chronic Obstructive Pulmonary Disease (COPD) 2. Pooled Analysis: Tiotropium (SPIRIVA®) RESPIMAT®: Evaluation of Fatal Events – February 2010  3. A Combined Analysis of Efficacy and Safety Data obtained in Studies 205.254and 205.255 – Two Randomised, double-blind, efficacy and safety comparisonsof one year treatment of two doses (5µg [2 actuations of 2.5µg] and (10µg [2actuations of 5µg] of Tiotropium Inhalation Solution Delivered by theRespimat® Inhaler in Patients with Chronic Obstructive Pulmonary Disease(COPD)

    Study Document Trial synopsis 205.255_DS_CO english Pooled analysis 205.255_DR english Combined analysis of 205.254 and 205.255_DS_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.282
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Spiriva® Assessment of FEV1 - (SAFE-Portugal). The effect of inhaled tiotropium bromide (18 mcg once daily) on the change in FEV1 during treatment in patients with COPD. A three-month parallel group, double-blind, randomised, placebo-controlled study

    Study Document Trial synopsis 205.282_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.315
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Special Survey Long-term Treatment of Tiotropium

    Study Document Trial synopsis 205.315 english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.365
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    A 24 week, randomized, double-blind, placebo controlled, multicenter study to evaluate the efficacy and safety of 18 MCG of tiotropium inhalation capsules administered by HandiHaler once-daily plus PRN albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy

    Study Document Trial synopsis 205.365_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.368
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    A randomized, double-blind, placebo-controlled two-year trial to examine the changes in Exercise Endurance and COPD treated with tiotropium (Spiriva® HandiHaler®) 18 µg once daily (EXACTT trial)

    Study Document Trial synopsis 205.368_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.399
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    An Observational Study to Collect the Safety and Effectiveness Data of Spiriva® in Patients with Chronic Obstructive Pulmonary Disease (COPD) under the Real Condition of Usual Practice (Fresh Air)

    Study Document Trial synopsis 205.399_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.243
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A Comparison of 18 µg of Tiotropium Inhalation Capsules and Atrovent® Metered Dose Inhaler (2 puffs of 20 µg, 4 times daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 205.243_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.244
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A Comparison of 18 µg of Tiotropium Inhalation Capsules and Atrovent Metered Dose Inhaler (2 puffs of 20 µg, 4 times daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults with Chronic Obstructive Pulmonary Disease (COPD).

    Study Document Trial synopsis 205.244_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.245
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A Comparison of 18 mcg of Tiotropium Inhalation Capsules once daily and Atrovent Metered Dose Inhaler (2 puffs of 20 mcg, 4 times daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 205.245_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.247
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A Randomized, Double Blind, Placebo Controlled Trial to compare the Effect of Tiotropium Inhalation Capsules on Exercise Tolerance in Patients with COPD Participating in 8 weeks of Pulmonary Rehabilitation

    Study Document Trial synopsis 205.247_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.249
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, double-dummy, placebo-controlled, crossover efficacy and safety comparison of 4-week treatment periods of two doses [5 µg (2 actuations of 2.5 µg) and 10 µg (2 actuations of 5 µg)] of tiotropium inhalation solution delivered by the Respimat inhaler, tiotropium inhalation powder capsule (18µg) delivered by the HandiHaler in patients with chronic obstructive pulmonary disease (COPD)

    Study Document Trial synopsis 205.249_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.250
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A randomised, double-blind, double-dummy, placebo-controlled, crossover efficacy and safety comparison of 4-week treatment periods of two doses [5 µg (2 actuations of 2.5 µg) and 10 µg (2 actuations of 5 µg)] of tiotropium inhalation solution delivered by the Respimat inhaler, tiotropium inhalation powder capsule (18µg) delivered by the HandiHaler in patients with chronic obstructive pulmonary disease (COPD)

    Study Document Trial synopsis 205.250_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.251
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    1. A Randomised, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel Group Efficacy and Safety Comparison of 12-Week Treatment of Two Doses [5 µg (2 actuations of 2.5 µg) and 10 µg (2 actuations of 5 µg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) in Patients with Chronic Obstructive Pulmonary Disease (COPD) 2. Pooled Analysis: Tiotropium (SPIRIVA®) RESPIMAT®: Evaluation of Fatal Events – February 2010

    Study Document Trial synopsis 205.251_CO english Pooled analysis 205.251_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.252
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    1. A Randomised, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel Group Efficacy and Safety Comparison of 12-Week Treatment of Two Doses [5 µg (2 actuations of 2.5 µg) and 10 µg (2 actuations of 5 µg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) in Patients with Chronic Obstructive Pulmonary Disease (COPD) 2. Pooled Analysis: Tiotropium (SPIRIVA®) RESPIMAT®: Evaluation of Fatal Events – February 2010

    Study Document Trial synopsis 205.252_CO english Pooled analysis 205.252_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.256
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    Effects of a 9-months treatment of SPIRIVA® on Health Related Quality of Life in patients with Chronic Obstructive Pulmonary Disease. Validation of a new HRQoL questionnaire appropriate to common daily practice. (TIPHON Study)

    Study Document Trial synopsis 205.256_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.257
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    Acute and long-term effects of once daily oral inhalation of tiotropium 18 mcg dry powder inhalation capsules in a placebo controlled parallel group design study in patients with Chronic Obstructive Pulmonary Disease (COPD) of different severity

    Study Document Trial synopsis 205.257_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.258
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    The acute bronchodilator effects of a single dose (2 puffs) of the short-acting anticholinergic ipratropium bromide (40 µg) and the short-acting beta-adrenergic fenoterol (200 µg) in comparison to placebo on top of pharmacodynamic steady state of once-daily tiotropium (18 µg) inhalation capsule in patients with chronic obstructive pulmonary disease (COPD)

    Study Document Trial synopsis 205.258_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.259
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    Spiriva® Assessment of FEV1 (SAFE). The effect of inhaled tiotropium bromide (18 mcg once daily) on the change in FEV1 during long-term treatment in patients with COPD. A one-year parallel group, double-blind, randomised, placebo-controlled study

    Study Document Trial synopsis 205.259_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.455
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Evaluation of COPD therapy as seen by the attending doctor using the example of tiotropium (Spiriva® HandiHalerTM/Spiriva® Respimat®)

    Study Document Trial synopsis 205.455_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.264
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol in a 12 Week, Randomized, Double-Blind, Double-Dummy, Parallel Group Study in Patients with Chronic Obstructive Pulmonary Disease (COPD).

    Study Document Trial synopsis 205.264_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.266
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomized, double-blind, placebo-controlled, parallel group trial assessing the proportion of patients experiencing an exacerbation and proportion of patients hospitalized for an exacerbation over 6 months during treatment with tiotropium 18 mcg capsule once daily in patients with COPD in a Veterans Affairs setting

    Study Document Trial synopsis 205.266_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.269
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double-blind, placebo-controlled, 12 week trial to evaluate the effect of Tiotropium Inhalation Capsules (Spiriva) on the magnitude of exercise, measured using an accelerometer, in patients with Chronic Obstructive Pulmonary Disease (COPD).

    Study Document Trial synopsis 205.269_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.270
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double-blind, parallel-group, placebo-controlled study to evaluate the Changes in Inflammatory Markers and Exacerbation Frequency in Induced Sputum following Treatment with Tiotropium Inhalation Capsules 18 mcg Once Daily in patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 205.270_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.273
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    A Six-Week, Randomised, Double-Blind, Triple-Dummy, Parallel Group, Multiple Dose, Pilot Study Comparing Tiotropium Inhalation Capsules to Salmeterol Inhalation Aerosol Combined with Fluticasone Inhalation Aerosol in Patients with Chronic Obstructive Pulmonary Disease (COPD).

    Study Document Trial synopsis 205.273_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.276
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised, double-blind, parallel group, 12 week study, comparing the effect of once daily tiotropium lactose capsule with placebo in patients with chronic obstructive pulmonary disease (COPD), naive to anticholinergic agents in addition to receiving their usual COPD care.

    Study Document Trial synopsis 205.276_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.280
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Safety and Efficacy of Tiotropium 18 mcg Inhalation Capsule Using a HandiHaler® Among Filipino COPD Subjects: A 30-Day, Open Label,Post Marketing Study

    Study Document Trial synopsis 205.280_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.281
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    A 12 week, double-blind, randomised, parallel-group, multi-centre study evaluating the efficacy of tiotropium versus placebo in patients with mild COPD according to Swedish guidelines (SPIRIMILD).

    Study Document Trial synopsis 205.281_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.284
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    Efficacy and Safety (including 24-hour Holter monitoring) of Tiotropium Inhalation Capsules in Patients with COPD (a 12-week, parallel group, randomized, placebo-controlled, double-blind study)

    Study Document Trial synopsis 205.284_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.287
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    A Six-Week, Randomized, Double-Blind, Quadruple-Dummy Parallel Group Multiple Dose Study Comparing the Efficacy and Safety of Tiotropium Inhalation Capsules plus Formoterol Inhalation Capsules to Salmeterol Inhalation Aerosol plus Fluticasone Inhalation Aerosol in Patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 205.287_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.289
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised, double-blind, placebo-controlled 7-week trial to investigate the effects of Tiotropium Inhalation Capsules (18 µg) once daily on exercise tolerance, daily activity and dyspnoea in patients with chronic obstructive pulmonary disease (COPD) participating in 3 weeks of pulmonary rehabilitation.

    Study Document Trial synopsis 205.289_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.291
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A randomised, double-blind, double-dummy, crossover efficacy and safety comparison of 4-week treatment periods of Ba 679 BR Respimat® 5 µg and tiotropium inhalation capsule 18 µg in patients with COPD

    Study Document Trial synopsis 205.291_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.294
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    An 8 week, Randomized, Placebo controlled, Double-blind Study to Assess the Efficacy of Tiotropium Inhalation Capsules in Patients of African Descent with Chronic Obstructive Pulmonary Disease

    Study Document Trial synopsis 205.294_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.301
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    A 12-week randomised, double blind, placebo controlled, parallel group trial evaluating the efficacy and safety of inhaled tiotropium 18µg q.d. in patients with COPD and a concomitant diagnosis of asthma

    Study Document Trial synopsis 205.301_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.320
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Effect of Spiriva® 18 microgram on health-related quality of life and physical functioning in patients with COPD and proven hyperinflation

    Study Document Trial synopsis 205.320_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.325
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    A randomized, double-blind, double-dummy, parallel group trial comparing 12 weeks treatment with tiotropium inhalation capsules 18 mcg via HandiHaler® once daily to Combivent® Inhalation Aerosol CFC MDI 2 actuations q.i.d. in COPD patients currently prescribed Combivent® Inhalation Aerosol CFC MDI

    Study Document Trial synopsis 205.325_DS_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.334
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Effect of inhalation of a free combination of tiotropium once daily 18 mcg and salmeterol twice daily 50 mcg versus a fixed combination of fluticasone and salmeterol twice daily (500/50 mcg) on static lung volumes and exercise tolerance in COPD patients (a randomised, double-blind, double dummy, 16 (2 x 8) weeks, crossover study)

    Study Document Trial synopsis 205.334_DS_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.337
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Regulatory requisite post marketing surveillance to assess the safety and efficacy of Spiriva® HandiHaler® (tiotropium bromide inhalation powder 18mcg, q.d.) in Korean COPD patients: A 30-Day, open label, non-interventional study

    Study Document Trial synopsis 205.337_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.373
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Evaluation of the efficacy and safety of Spiriva® 18 µg once daily in Chinese COPD patients with different disease severities for 8 weeks.

    Study Document Trial synopsis 205.373_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.392
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A Retrospective Collection of Vital Status and Pulmonary Medication Usage Data for Patients with Chronic Obstructive Pulmonary Disease (COPD) who Withdrew Prematurely from Either of Two One-Year Trials (205.254, 205.255) of Tiotropium Inhalation Solution Delivered by the Respimat® Inhaler

    Study Document Trial synopsis 205.392_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.398
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Impact of Spiriva® on the Activities-of -Daily-Living-Score (ADL-Score), which is recommended in the Austrian Guidelines for the treatment of COPD

    Study Document Trial synopsis 205.398_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.346
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    A randomized, double-blind, double-dummy, parallel group trial comparing 12 weeks treatment with tiotropium inhalation capsules 18 mcg via HandiHaler® once daily to Combivent® Inhalation Aerosol CFC MDI 2 actuations q.i.d. in COPD patients currently prescribed Combivent® Inhalation Aerosol CFC MDI

    Study Document Trial synopsis 205.346_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.364
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Effect of Spiriva® 18 microgram on health-related quality of life in COPD patients who stopped smoking during treatment

    Study Document Trial synopsis 205.364_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.372
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    1. A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Long Term (one-year) Efficacy and Safety of Tiotropium Inhalation Solution 5 µg (2 puffs of 2.5 µg) Delivered by the Respimat® Inhaler in Patients with Chronic Obstructive Pulmonary Disease (COPD) 2. Pooled Analysis: Tiotropium (SPIRIVA®) RESPIMAT®: Evaluation of Fatal Events – February 2010

    Study Document Trial synopsis 205.372_DR english Pooled analysis 205.372_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.389
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Effect of inhalation of tiotropium once daily 18 mcg versus salmeterol twice daily 50 mcg on time to first exacerbation in COPD patients (a randomised, double-blind, double-dummy, parallel group, one-year study). The POET-COPD® study - Prevention Of Exacerbations with Tiotropium

    Study Document Trial synopsis 205.389_DS_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.396
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    RUSSE / Russian Spiriva® Safety & Efficacy Study. The efficacy and safety of Spiriva® 18 mcg inhalation capsules once daily in reallife setting of Russian COPD patients

    Study Document Trial synopsis 205.396_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.402
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Improvement in physical functioning (SF-36 activity score) in COPD patients with exercise-induced dyspnoea on treatment with Spiriva® 18 Microgram (capsules containing 18 µg tiotropium).

    Study Document Trial synopsis 205.402_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.426
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Assessment of physical activity (PF10 sub domain of SF-36 activity score) and tolerability in COPD patients during treatment with Spiriva® Respimat®

    Study Document Trial synopsis 205.426 english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.450
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    SOSPES: Spiriva® Observational Study measuring SGRQ in Routine Medical Practice in Central & Eastern European Region

    Study Document Trial synopsis 205.450_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.458
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A multicentre, randomised, placebo- and active-controlled, 5-way crossover trial   to characterise the pharmacokinetics and evaluate the bronchodilator efficacy and safety of once-daily tiotropium delivered (double-blind) from the Respimat® inhaler as solution for inhalation (1.25, 2.5, 5µg or placebo) and as inhalation powder (18µg) from the HandiHaler® (open-label) after 4 week-treatment periods in patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 205.458_DS_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.474
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Can a daily reminder via SMS improve adherence of COPD patients – taking the example of Spiriva® HandiHaler™?

    Study Document Trial synopsis 205.474_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.440
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    A randomized, double-blind, placebo-controlled, 6-week, cross-over study to examine the effects of tiotropium bromide (Spiriva® HandiHaler®, 18 µg once daily) on lung dynamic hyperinflation and physical exercise endurance in patients with early stage Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 205.440_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.463
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post Marketing Surveillance on Long-Term Drug Use of Spiriva 2.5 µg Respimat® 60 puffs in Patients with Chronic Obstructive Pulmonary Disease

    Study Document Trial synopsis 205.463_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.479
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    A 12-week, randomised, placebo-controlled, double-blind, parallel group,multi-center trial to assess the efficacy and safety of tiotropium bromide (18 µg) delivered via the HandiHaler® in patients with newly diagnosed and/or maintenance treatment naive Chronic Obstructive Pulmonary Disease (COPD) experiencing an acute respiratory infection (TICARI 1: Tiotropium In COPD patients with an Acute Respiratory Infection 1)

    Study Document Trial synopsis 205.479_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.452
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, active-controlled, double-blind, double-dummy, parallel groupdesign, multi-center trial to compare the efficacy and safety of 2.5 µg and 5 µgTiotropium Inhalation Solution delivered by the Respimat® Inhaler withTiotropium inhalation capsules 18 µg delivered by the HandiHaler®

    Study Document Trial synopsis 205.452_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.483
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    ADESPI: Adherence to Spiriva® in Patients with COPD, measured by Morisky-8 (MMAS-8) Scale, in routine medical practice in Central & Eastern European Region

    Study Document Trial synopsis 205.483_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.127
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIa
    Study Title

    Pharmacodynamic and pharmacokinetic dose ranging study of tiotropium bromide administered via Respimat device in patients with chronic obstructive pulmonary disease (COPD): a randomized, 3-week multiple-dose, placebo contolled, intraformulation double-blind, parallel group study.

    Study Document Trial synopsis 205.127 english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.130
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A multiple dose comparison of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo in a six month, double blind, double dummy,safety and efficacy study in patients with chronic obstructive pulmonary disease (COPD)

    Study Document Trial synopsis 205.130 english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.131
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    Effects of Tiotropium on Exercise Tolerance and Static and Dynamic Lung Volumes in COPD Patients (A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study). Oral Inhalation Once Daily for 6 Weeks from An Inhalation Capsule Containing 18 µg Tiotropium.

    Study Document Trial synopsis 205.131 english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.133
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    The Pharmacokinetics, Safety and Tolerability ofTiotropium in Elderly COPD Patients (Open Label, Monocentre Study)

    Study Document Trial synopsis 205.133_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.137
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIa
    Study Title

    A multiple dose comparison of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo in a six month, double blind, double dummy, safety and efficacy study in patients with chronic obstructive pulmonary disease

    Study Document Trial synopsis 205.137 english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.139
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIa
    Study Title

    Dose ranging study of BA 679 BR inhalation powder following single inhalation in COPD patients - double-blind, placebo-controlled, 4 treatment, 4 period crossover study.

    Study Document Trial synopsis 205.139_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.218
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    The effects of tiotropium on airway diameter in patients with COPD

    Study Document Trial synopsis 205.218_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.232
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A Comparison of 18 mcg of Tiotropium Inhalation Capsules and ATROVENT Metered Dose Inhaler (2 puffs of 20 mcg) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 205.232_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.261
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double-blind, double-dummy, placebo-controlled, crossover comparison of the effect of 6-week treatment periods of tiotropium inhalation capsules (18mcg) and salmeterol inhalation aerosol on muscular efficiency and resting energy expenditure (REE) in patients with stable chronic obstructive pulmonary disease (COPD).

    Study Document Trial synopsis 205.261_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.277
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Tolerability and efficacy of Spiriva 18 micrograms in patients with COPD in daily practice

    Study Document Trial synopsis 205.277 english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.278
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Tolerability and efficacy of Spiriva 18 micrograms in patients with COPD in daily practice.

    Study Document Trial synopsis 205.278 english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.314
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Drug Use Results Survey of Tiotropium bromide

    Study Document Trial synopsis 205.314 english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.478
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    A randomized, placebo-controlled, double-blind, parallel group, multi center study to assess the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation (Hospital Discharge Study 2)

    Study Document Trial synopsis 205.478_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.477
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    A randomized, placebo-controlled, double-blind, parallel group, multi-center study to assess the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation (Hospital Discharge Study 1)

    Study Document Trial synopsis 205.477_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.514
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase I
    Study Title

    Cross-sectional study to assess the handling, patient satisfaction, and preference for inhalation devices in patients with chronic obstructive pulmonary disease (COPD).

    Study Document Trial synopsis 205.514_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.502
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    MATHS: Assessment of health-status of patients with Chronic Obstructive Pulmonary Disease (COPD) on MAintenance THerapy with Spiriva® HandiHaler® measured by COPD Assessment Test (CAT) test

    Study Document Trial synopsis 205.502_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.214
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb/IV
    Study Title

    Effect of inhaled tiotropium bromide (18 mcg once daily) on the severity of airflow obstruction during long-term treatment in patients with moderately severe COPD. Impact on severity and incidence of exacerbations. A one-year parallel-group, double-blind, randomized, placebo-controlled study

    Study Document Trial synopsis 205.214_CO english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.526
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Combined bronchodilators in chronic obstructive pulmonary disease and the risk of adverse cardio-pulmonary events: A population-based observational study

    Study Document Trial synopsis 205.526_DR english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 352.2046
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised, double-blind, active-controlled study to evaluate the impact of stepwise withdrawal of inhaled corticosteroids in patients with severe to very severe chronic obstructive pulmonary disease (COPD) on optimised bronchodilator therapy

    Study Document Trial synopsis 352.2046_DR english
  • STRIVERDI ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1222.3
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase IIa
    Study Title

    Randomised, Double-Blind, Placebo-Controlled, 5-Way Cross-Over Study to   Assess the Efficacy and Safety of a Single Dose of Orally Inhaled BI 1744 CL (2 µg, 5 µg, 10 µg, 20 µg) in COPD Patients Followed by Open-Label BI 1744 CL (40 µg)

    Study Document Trial Synopsis 1222.3_DS_CO english
  • STRIVERDI ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1222.5
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase IIb
    Study Title

    Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL (2 µg, 5 µg, 10 µg, 20 µg) Delivered by the Respimat® Inhaler in Patients with COPD

    Study Document Trial synopsis 1222.5_DR english
  • STRIVERDI ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1222.11
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    Randomised, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of 48 weeks of once daily treatment of orally inhaled BI 1744 CL (5 µg [2 actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg]) delivered by  the Respimat® inhaler, in patients with Chronic Obstructive Pulmonary Disease (COPD) 2. Combined analysis of efficacy and safety data obtained in Studies 1222.11 and1222.12 - Randomised, double-blind, placebo-controlled, parallel group studiesto assess the efficacy and safety of 48 weeks of once daily treatment of orallyinhaled BI 1744 CL (5 µg [2 actuations of 2.5 mcg] and 10 mcg [2 actuations of5 mcg]) delivered by the Respimat® inhaler, in patients with chronic obstructivepulmonary disease (COPD)

    Study Document Trial synopsis 1222.11_DS_DR english Combined analysis 1222.11_­DS_DR english
  • STRIVERDI ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1222.12
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    Randomised, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of 48 weeks of once daily treatment of orally inhaled BI 1744 CL (5 µg [2 actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg]) delivered by the Respimat® inhaler, in patients with Chronic Obstructive Pulmonary Disease (COPD) 2. Combined analysis of efficacy and safety data obtained in Studies 1222.11 and1222.12 - Randomised, double-blind, placebo-controlled, parallel group studiesto assess the efficacy and safety of 48 weeks of once daily treatment of orallyinhaled BI 1744 CL (5 µg [2 actuations of 2.5 mcg] and 10 mcg [2 actuations of5 mcg]) delivered by the Respimat® inhaler, in patients with chronic obstructivepulmonary disease (COPD) 

    Study Document Trial synopsis 1222.12_DR english Combined analysis 1222.12_DS_DR english
  • STRIVERDI ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1222.13
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    1. A randomised, double-blind, double-dummy, placebo-controlled, parallel group study to assess the efficacy and safety of 48 weeks of once daily treatment of orally inhaled BI 1744 CL (5 µg [2 actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg]) delivered by the Respimat® Inhaler, and 48 weeks of twice daily Foradil® (12 µg) delivered by the Aerolizer® Inhaler, in patients with Chronic Obstructive Pulmonary Disease (COPD)   2. Combined analysis of studies 1222.13 and 1222.14: randomised, double-blind,double-dummy, placebo-controlled, parallel group studies to assess the efficacyand safety of 48 weeks of once daily treatment of orally inhaled BI 1744 CL(5 µg [2 actuations of 2.5 ?g] and 10 ?g [2 actuations of 5 ?g]) delivered by theRespimat® Inhaler, and 48 weeks of twice daily Foradil® (12 µg) delivered by theAerolizer® Inhaler, in patients with chronic obstructive pulmonary disease(COPD)

    Study Document Trial synopsis 1222.13_DR english Combined analysis 1222.13_DS_DR english
  • STRIVERDI ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1222.14
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    1. A randomised, double-blind, double-dummy, placebo-controlled, parallel group study to assess the efficacy and safety of 48 weeks of once daily treatment of orally inhaled BI 1744 CL (5 µg [2 actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg]) delivered by the RESPIMAT® Inhaler, and 48 weeks of twice daily Foradil® (12 µg) delivered by the Aerolizer® Inhaler, in patients with Chronic Obstructive Pulmonary Disease (COPD) 2. Combined analysis of studies 1222.13 and 1222.14: randomised, double-blind,double-dummy, placebo-controlled, parallel group studies to assess the efficacyand safety of 48 weeks of once daily treatment of orally inhaled BI 1744 CL(5 µg [2 actuations of 2.5 ?g] and 10 ?g [2 actuations of 5 ?g]) delivered by theRespimat® Inhaler, and 48 weeks of twice daily Foradil® (12 µg) delivered by theAerolizer® Inhaler, in patients with chronic obstructive pulmonary disease(COPD)

    Study Document Trial synopsis 1222.14_DR english Combined analysis 1222.14_DS_DR english
  • STRIVERDI ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1222.22
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase IIb
    Study Title

    Randomised, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of 4 weeks of once daily treatment of orally inhaled BI 1744 CL (2 µg, 5 µg, 10 µg) delivered by the Respimat® inhaler in Japanese patients with COPD

    Study Document Trial synopsis 1222.22_DS_CO english
  • STRIVERDI ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1222.24
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    1. Randomized, double-blind, double-dummy, placebo-controlled, four-way cross-over study to determine the 24-hour FEV1-time profiles of orally inhaled BI 1744 CL (5 µg [two actuations of 2.5 µg] and 10 µg [two actuations of 5 µg]), administered once daily with the Respimat® Inhaler, and orally inhaled Foradil® (12 µg), administered twice daily with the Aerolizer® Inhaler, after six weeks of treatment in patients with Chronic Obstructive Pulmonary Disease (COPD) 2. Combined analysis of efficacy data obtained in Studies 1222.24 and 1222.25 -Randomised, double-blind, double-dummy, placebo controlled, 4-waycross-over studies to determine the 24-hour FEV1-time profiles of orally inhaledBI 1744 CL (5 µg [2 actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg]),administered once daily with the Respimat® Inhaler, and orally inhaledForadil® (12 µg) administered twice daily with the Aerolizer® Inhaler, after6 weeks of treatment in patients with chronic obstructive pulmonarydisease (COPD)

    Study Document Trial synopsis 1222.24_DS_DR english Combined analysis 1222.24_DS_DR english
  • STRIVERDI ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1222.25
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    1. Randomized, double-blind, double-dummy, placebo-controlled, 4-way cross-over study to determine the 24-hour FEV1-time profiles of orally inhaled BI 1744 CL (5 µg [2 actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg]), administered once daily with the Respimat® Inhaler, and orally inhaled Foradil® (12 µg), administered twice daily with the Aerolizer® Inhaler, after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease (COPD) 2. Combined analysis of efficacy data obtained in Studies 1222.24 and 1222.25 -Randomised, double-blind, double-dummy, placebo controlled, 4-waycross-over studies to determine the 24-hour FEV1-time profiles of orally inhaledBI 1744 CL (5 µg [2 actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg]),administered once daily with the Respimat® Inhaler, and orally inhaledForadil® (12 µg) administered twice daily with the Aerolizer® Inhaler, after6 weeks of treatment in patients with chronic obstructive pulmonarydisease (COPD)

    Study Document Trial synopsis 1222.25_DS_DR english Combined analysis 1222.25_DS_DR english
  • STRIVERDI ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1222.26
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase IIb
    Study Title

    Randomised, double-blind, 4-way cross-over study to determine the 24-hour FEV1-time profile of orally inhaled BI 1744 CL, delivered with the Respimat® inhaler, after 3 weeks of once daily (5 µg [2 actuations of 2.5 µg], 10 µg [2 actuations of 5 µg]) or twice daily (2 µg [2 actuations of 1 µg], 5 µg [2 actuations of 2.5 µg]) administration in patients with chronic obstructive pulmonary disease (COPD)

    Study Document Trial synopsis 1222.26_DR english
  • STRIVERDI ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1222.37
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    Randomised, double-blind, placebo-controlled, 3-way cross-over study to determine the effect of 6 weeks treatment of orally inhaled BI 1744CL (5 µg [2 actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg]) delivered by the Respimat® Inhaler on exercise endurance time during constant work rate cycle ergometry in patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1222.37_DR english
  • STRIVERDI ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1222.38
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    Randomised, double-blind, placebo-controlled, 3-way cross-over study to determine the effect of 6 weeks treatment of orally inhaled BI 1744 CL (5 µg [2 actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg]) delivered by the Respimat® Inhaler on exercise endurance time during constant work rate cycle ergometry in patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1222.38_DR english
  • STRIVERDI ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1222.39
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    1. Randomised, double-blind, double-dummy, placebo-controlled, 4-way   cross-over study to characterise the 24-hour FEV1-time profiles of BI 1744 CL 5 µg and 10 µg (oral inhalation, delivered by the Respimat® Inhaler) and tiotropium bromide 18µg (oral inhalation, delivered by the HandiHaler®) after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease (COPD) 2. Combined analysis of efficacy data obtained in Studies 1222.39 and 1222.40 -Randomised, double-blind, double-dummy, placebo-controlled, 4-waycross-over study to characterise the 24-hour FEV1-time profiles of BI 1744 CL5 µg and 10 µg (oral inhalation, delivered by the Respimat® Inhaler) andtiotropium bromide 18 µg (oral inhalation, delivered by the HandiHaler®) after6 weeks of treatment in patients with chronic obstructive pulmonarydisease (COPD)

    Study Document Trial synopsis 1222.39_DS_CO english Combined analyis 1222.39_DS_DR english
  • STRIVERDI ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1222.40
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    1. Randomised, double-blind, double-dummy, placebo-controlled, 4-way cross-over study to characterise the 24-hour FEV1-time profiles of BI 1744 CL 5 µg and 10 µg (oral inhalation, delivered by the Respimat® Inhaler) and tiotropium bromide 18µg (oral inhalation, delivered by the HandiHaler®) after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease (COPD) 2. Combined analysis of efficacy data obtained in Studies 1222.39 and 1222.40 -Randomised, double-blind, double-dummy, placebo-controlled, 4-waycross-over study to characterise the 24-hour FEV1-time profiles of BI 1744 CL5 µg and 10 µg (oral inhalation, delivered by the Respimat® Inhaler) andtiotropium bromide 18 µg (oral inhalation, delivered by the HandiHaler®) after6 weeks of treatment in patients with chronic obstructive pulmonarydisease (COPD)

    Study Document Trial synopsis 1222.40_DR english Combined analyis 1222.40_DS_DR english
  • STRIVERDI ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1222.51
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double blind, parallel group study to assess the efficacy and safety of 12 weeks of once daily, orally inhaled, co-administration of olodaterol 5µg (delivered by the Respimat® Inhaler) and tiotropium 18µg (delivered by the HandiHaler®) compared to once daily, orally inhaled, co-administration of placebo (delivered by the Respimat® Inhaler) and tiotropium 18µg (delivered by the HandiHaler®) in patients with Chronic Obstructive Pulmonary Disease (COPD)[ANHELTO TM 1]

    Study Document Trial synopsis 1222.51_CO english
  • STRIVERDI ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1222.52
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double blind, parallel group study to assess the efficacy and safety of 12 weeks of once daily, orally inhaled, co-administration of olodaterol 5µg (delivered by the Respimat® Inhaler) and tiotropium 18µg (delivered by the HandiHaler®) compared to once daily, orally inhaled, co-administration of placebo (delivered by the Respimat® Inhaler) and tiotropium 18µg (delivered by the HandiHaler®) in patients with Chronic Obstructive Pulmonary Disease (COPD) [ANHELTO TM 2]

    Study Document Trial synopsis 1222.52_CO english
  • STRIVERDI ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1222.56
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase IV
    Study Title

    Changes in physical functioning in patients with COPD duringtherapy with a combination of Spiriva® Respimat® + Striverdi®Respimat® or Spiriva® 18 Mikrogramm + Striverdi® Respimat®

    Study Document Trial synopsis 1222.56_DR english
  • Tiotropium - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1249.1
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Tiotropium
    Generic Name Tiotropium + Salmeterol + Fluticasone; Tiotropium+ Salmeterol + Ciclesonide
    Lab Code
    Clinical Phase II
    Study Title

    A Randomised, Phase II, Double-Blind, Double-Dummy, four-period Crossover Efficacy and Safety Comparison of 4-Week Treatment Periods of Blinded Fluticasone (500 mcg bid, MDI), Ciclesonide (400 mcg qd, MDI), Ciclesonide (800 mcg qd, MDI) or placebo in Free Combination with Open-Label Tiotropium (18 mcg qd, HandiHaler) and Salmeterol (50 mcg bid, Diskus) in Patients with COPD

    Study Document Trial synopsis 1249.1_DR english
  • Tiotropium bromide + Salmeterol - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1184.10
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Tiotropium bromide + Salmeterol
    Generic Name Tiotropium bromide + Salmeterol
    Lab Code
    Clinical Phase II
    Study Title

    A single dose, placebo-controlled, randomized, double-blind, double-dummy, crossover efficacy, pharmacokinetics and safety comparison of salmeterol inhalation powder (25 µg salmeterol), administered as the xinafoate salt from a hard polyethylene capsule via the HandiHaler® 2, and Serevent® Diskus® (50 µg salmeterol) in patients with chronic obstructive pulmonary disease (COPD)

    Study Document Trial synopsis 1184.10_DR english
  • Tiotropium bromide + Salmeterol - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1184.12
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Tiotropium bromide + Salmeterol
    Generic Name Tiortopium bromide + Salmeterol
    Lab Code
    Clinical Phase II
    Study Title

    A single dose, placebo-controlled, randomized, double-blind, double-dummy, crossover efficacy, pharmacokinetics and safety comparison of salmeterol inhalation powder (12.5 µg, 25 µg and 50 µg salmeterol), administered as the xinafoate salt from hard polyethylene capsules via the HandiHaler® 2, and Serevent® Diskus® (50 µg salmeterol) in patients with chronic obstructive pulmonary disease (COPD)

    Study Document Trial synopsis 1184.12_DR english
  • Tiotropium bromide + Salmeterol - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1184.13
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Tiotropium bromide + Salmeterol
    Generic Name Tiotropium bromide + Salmeterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, crossover efficacy and safety comparison of Tiotropium/Salmeterol (7.5 µg/25 µg) Inhalation Powder in the morning (PE Capsule via tiotropium/salmeterol HandiHaler®), Tiotropium (18 µg) Inhalation Powder in the morning (gelatine capsule via Spiriva® HandiHaler®), Salmeterol (50 µg) Multi-Dose Powder Inhaler in the morning and evening and the free combination Tiotropium (18 µg) Inhalation Powder in the morning (gelatine capsule via Spiriva® HandiHaler®) plus Salmeterol (50 µg) Multi-Dose Powder Inhaler in the morning and evening following chronic administration (6-week treatment periods) in patients with COPD

    Study Document Trial synopsis 1184.13_DR english
  • Tiotropium bromide + Salmeterol - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1184.14
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Tiotropium bromide + Salmeterol
    Generic Name Tiotropium bromide + Salmeterol
    Lab Code
    Clinical Phase III
    Study Title

    A 24-week (+ 24 week extension) placebo-controlled (only 1st 12-week period), double–blind, parallel-group, efficacy and safety comparison of FDC Tiotropium/Salmeterol, Tiotropium, Salmeterol and FDC Tiotropium/Salmeterol plus Salmeterol in COPD patients

    Study Document Trial synopsis 1184.14 english
  • Tiotropium bromide + Salmeterol - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1184.15
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Tiotropium bromide + Salmeterol
    Generic Name Tiotropium bromide + Salmeterol
    Lab Code
    Clinical Phase III
    Study Title

    A 24-week (+ 24 week extension) placebo-controlled (only 1st 12-week period), double–blind, parallel-group, efficacy and safety comparison of FDC Tiotropium/Salmeterol, Tiotropium, Salmeterol and FDC Tiotropium/Salmeterol plus Salmeterol in COPD patients

    Study Document Trial synopsis 1184.15 english
  • Tiotropium bromide + Salmeterol - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1184.9
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Tiotropium bromide + Salmeterol
    Generic Name Tiotropium bromide + Salmeterol
    Lab Code
    Clinical Phase II
    Study Title

    A single dose, placebo-controlled, randomized, double-blind, double-dummy, crossover efficacy, pharmacokinetics and safety comparison of tiotropium inhalation powder (5 µg and 10 µg), administered as the bromide salt from hardpolyethylene capsule via the HandiHaler® 2, and Spiriva® HandiHaler® (18 µg tiotropium) in patients with chronic obstructive pulmonary disease (COPD).

    Study Document Trial synopsis 1184.9_DR english
  • Tiotropium bromide + Salmeterol - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1184.24
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Tiotropium bromide + Salmeterol
    Generic Name Tiotropium bromide + Salmeterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, open-label, 4-way crossover study to characterize the pharmacokinetics, safety and efficacy of FDC Tiotropium/Salmeterol,Tiotropium, Salmeterol and a free combination of Tiotropium plus Salmeterol following 4-week treatment periods in patients with COPD.

    Study Document Trial synopsis 1184.24 english
  • BI 113608 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1314.5
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BI 113608
    Generic Name BI 113608
    Lab Code BI 113608
    Clinical Phase I
    Study Title

    Randomized, placebo-controlled, double-blind within dose groups, multiple rising-dose study to evaluate safety, tolerability, and PK of oral BI 113608 administered as tablets twice daily over 4 weeks in patients with COPD associated with chronic bronchitis

    Study Document Trial synopsis 1314.5 english
  • SPIRIVA ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 205.517
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-Marketing Observational Study of the Impact of Adherence to Treatment with Once-Daily Administered Long-Acting Bronchodilators (LABAs / LAMAs) on Patients’ Health–Related Quality of Life in COPD Patient

    Study Document Trial synopsis 205.517_PR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.49
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IV
    Study Title

    A 4-week, randomised, double-blind, parallel group study to evaluate the efficacy and safety of tiotropium+olodaterol fixed-dose combination (5/5 μg) delivered by the RESPIMAT® inhaler versus the free combination of tiotropium 5 μg and olodaterol 5 μg delivered by separate RESPIMAT® inhalers in patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1237.49 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.42
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol , Tramazoline
    Lab Code
    Clinical Phase IV
    Study Title

    SPIRIT: Assessment of physical functioning and handling of Spiolto® Respimat® in patients with chronic obstructive pulmonary disease (COPD) requiring long-acting dual bronchodilation in routine clinical practice

    Study Document Trial synopsis 1237.42 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.33
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double-blinded, active-controlled 2-way crossover trial to assess the effects of 6 weeks once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination delivered by RESPIMAT Inhaler compared with tiotropium delivered by RESPIMAT Inhaler on lung hyperinflation, exercise capacity, and physical activity in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1237.33 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.19
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double-blind, active-controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed-dose combination compared with tiotropium on Chronic Obstructive Pulmonary Disease (COPD) exacerbation in patients with severe to very severe COPD. [DYNAGITO]

    Study Document Trial synopsis 1237.19 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.44
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IV
    Study Title

    Assessment of physical functioning and handling of Spiolto® Respimat® in patients with chronic obstructive pulmonary disease (COPD) requiring long-acting dual bronchodilation in routine clinical practice

    Study Document Trial synopsis 1237.44 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.30
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase Ib
    Study Title

    An open-label trial to assess pharmacokinetics and safety of tiotropium + olodaterol fixed-dose combination (5 μg/ 5 μg) delivered by the RESPIMAT® inhaler after single and multiple dose treatment in Chinese patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1237.30 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.28
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised, double-blind, cross-over study to evaluate the effect of 6 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (5/5 μg) compared with tiotropium (5 μg), both delivered by the Respimat® Inhaler, on breathlessness during the three minute Constant Speed Shuttle Test (3min CSST) in patients with Chronic Obstructive Pulmonary Disease (COPD) [OTIVATOTM]

    Study Document Trial synopsis 1237.28 english Lay summary 1237.28 english Lay summary 1237.28 dutch Lay summary 1237.28 french Lay summary 1237.28 german
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.51
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IV
    Study Title

    SATisfaction and adherence to COPD treatment

    Study Document Trial synopsis 1237.51 english
  • BI 1026706 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1320.16
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BI 1026706
    Generic Name BI 1026706
    Lab Code BI 1026706
    Clinical Phase Ic
    Study Title

    A Phase I randomized, double-blind, placebo-controlled, parallel-group trial of BI 1026706 administered orally as tablets twice daily for 4 weeks to patients with COPD in order to evaluate safety, tolerability, pharmacokinetics and effect on inflammation

    Study Document Trial synopsis 1320.16 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.45
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IV
    Study Title

    Assessment of physical functioning and handling of Spiolto® Respimat® in patients with chronic obstructive pulmonary disease (COPD) requiring longacting dual bronchodilation in routine clinical practice.

    Study Document Trial synopsis 1237.45 english

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