Value through Innovation27 July 2016

Clinical Study Results

  • ATROVENT ® - Asthma
    Clinical Study Number 244.2413
    Study Indication Asthma
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Double-blind, controlled trial to assess the efficacy of ipratropium bromide associated with high dose salbutamol by repeated nebulisation versus repeated nebulisation of salbutamol alone, for 120 minutes, in acute asthmatic attacks in young children.

    Study Document Trial synopsis 244.2413_CO english
  • Amelubant - Asthma
    Clinical Study Number 543.11
    Study Indication Asthma
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase IIa
    Study Title

    The effect BIIL 284 BS ( 14 day treatment) on induced-sputum variables in patients with bronchial asthma (a double-blind. randomized, placebo-controlled parallel study)

    Study Document Trial synopsis 543.11_CO english
  • BERODUAL ® - Asthma
    Clinical Study Number 215.1104
    Study Indication Asthma
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase III
    Study Title

    Comparison of the safety and efficacy of Berodual® administered via Respimat® device (50 mcg fenoterol hydrobromide/20 mcg ipratropium bromide and 25 mcg fenoterol hydrobromide/10 mcg 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 asthma patients over a 12-week period.

    Study Document Trial synopsis 215.1104 english
  • BERODUAL ® - Asthma
    Clinical Study Number 215.1105
    Study Indication Asthma
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind study to compare the safety and efficacy of Berodual® inhaled via the Respimat® device in two dosages (50 µg fenoterol hydrobromide + 20 µg ipratropium bromide and 25 µg fenoterol hydrobromide + 10 µg ipratropium bromide, 1 puff t.i.d) with that of Berodual® inhaled via the Chlorofluorocarbons (CFC)-metered dose inhaler (MDI) with Aerochamber® (50 µg fenoterol hydrobromide + 21 µg ipratropium bromide, 2 puffs t.i.d.) in paediatric patients with asthma over a 4 week period

    Study Document Trial synopsis 215.1105 english
  • BI 54903 - Asthma
    Clinical Study Number 1248.5
    Study Indication Asthma
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double-blind, double-dummy, placebo-controlled, parallel-group study to assess and compare efficacy and safety of an 8-week treatment with BI 54903 at doses of 22.7, 45.5 and 90.9 µg b.i.d. administered via Respimat® inhaler and fluticasone propionate HFA MDI 88 µg b.i.d. in patients with asthma inadequately controlled on SABA therapy

    Study Document Trial statement 1248.5_DR english Trial synopsis 1248.5_6_7_DR english
  • BI 54903 - Asthma
    Clinical Study Number 1248.6
    Study Indication Asthma
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double-blind, double-dummy, placebo-controlled, parallel-group study to assess and compare efficacy and safety of an 8-week treatment with BI 54903 at doses of 45.5, 90.9 and 181.8 µg b.i.d. administered via Respimat® inhaler and fluticasone propionate HFA MDI 220 µg b.i.d. in patients with asthma inadequately controlled on low dose ICS therapy

    Study Document Trial statement 1248.6_DR english Trial synopsis 1248.5_6_7_DR english
  • BI 54903 - Asthma
    Clinical Study Number 1248.7
    Study Indication Asthma
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double-blind, double-dummy, active-controlled, parallel-group study to assess and compare efficacy and safety of an 8-week treatment with BI 54903 at doses of 90.9, 181.8 and 363.6 µg b.i.d. administered via Respimat® inhaler and fluticasone propionate HFA MDI 440 µg b.i.d. in patients with asthma inadequately controlled on medium dose ICS therapy

    Study Document Trial statement 1248.7_DR english Trial synopsis 1248.5_6_7_DR english
  • BI 54903 - Asthma
    Clinical Study Number 1249.7
    Study Indication Asthma
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase IIa
    Study Title

    A single dose, placebo-controlled, randomised, double-blind double dummy, 5-way crossover (7 treatments, 5 periods incomplete block), including 24-h pulmonary function tests, pharmacodynamic comparison of olodaterol/BI 54903 fixed dose combination inhalation solutions via Respimat® (including clinical doses of 1.23/363.6 µg, 2.46/363.6 µg and 4.93/363.6 µg) versus free combinations of olodaterol inhalation solutions (0, 2.5µg, 5 µg and 10 µg) via Respimat® plus BI 54903 inhalation solution (363.6 µg ) in patients with asthma.

    Study Document Trial statement 1249.7_DR english
  • BI 54903 - Asthma
    Clinical Study Number 1256.13
    Study Indication Asthma
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase Ib
    Study Title

    Serial lung function measurements in 12 healthy and 48 mild asthmatic adults after oral inhalation of ethanolic solutions containing two concentrations of the excipient butylated hydroxytoluene (BHT, 0.1% and 0.5%) administered with the Respimat® B (RMT-B) vs. corresponding RMT-B and HFA MDI without BHT; repeated increasing doses with 2, 4, and 6 actuations of low concentration prior to high concentration on separate days, double blind for RMT-B use, randomised 4-way cross-over design

    Study Document Trial synopsis 1256.13_CO english
  • BI 671800 - Asthma
    Clinical Study Number 1268.16
    Study Indication Asthma
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase IIa
    Study Title

    Randomised, double-blind, double-dummy, placebo-controlled, parallel group study to assess the efficacy and safety of 6 weeks of oral BI 671800 ED 400 mg b.i.d., Montelukast 10 mg q.d., or placebo in symptomatic asthma patients on fluticasone propionate MDI

    Study Document Trial synopsis 1268.16 english
  • BI 671800 - Asthma
    Clinical Study Number 1268.53
    Study Indication Asthma
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomised, double-blind, placebo-controlled, efficacy and safety cross-over study of 4 weeks of oral BI 671800 ED 200 mg twice daily or 400 mg once daily administered in the morning (AM) or evening (PM), in symptomatic asthma patients on inhaled fluticasone propionate MDI

    Study Document Trial synopsis 1268.53_DR english
  • BI 671800 - Asthma
    Clinical Study Number 1268.17
    Study Indication Asthma
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomized, double blind, placebo and active controlled, parallel group study to evaluate the safety and efficacy of 6-week treatment with oral doses of 50 mg b.i.d., 200 mg b.i.d., and 400 mg b.i.d. BI 671800 ED in steroid-naive patients with persistent asthma

    Study Document Trial synopsis 1268.17_DR english
  • COMBIVENT ® - Asthma
    Clinical Study Number 1012.50
    Study Indication Asthma
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase IIb
    Study Title

    A single dose randomized, double-blind crossover comparison of COMBIVENT® CFC MDI and albuterol HFA MDI in patients with moderate to severe persistent asthma and persistent symptoms despite treatment with inhaled corticosteroids

    Study Document Trial synopsis 1012.50_CO english
  • COMBIVENT ® - Asthma
    Clinical Study Number 1012.57
    Study Indication Asthma
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase II
    Study Title

    A multicenter, randomized study starting with a 4-week, 2-way crossover double-blind treatment phase comparing the efficacy and safety of Combivent® CFC MDI to albuterol HFA MDI followed by a 4-week open-label Combivent® Respimat® treatment phase when all study drugs are used for symptom relief “as needed” in patients with moderate-to-severe asthma (GINA 2007 Treatment Steps 3-5)

    Study Document Trial synopsis 1012.57_DS_CO english
  • COMBIVENT ® - Asthma
    Clinical Study Number 1012.32
    Study Indication Asthma
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase III
    Study Title

    Open Study on the Efficacy and Safety of CombiVent® Aerosol (120 mcg Salbutamol sulfate+ 20 mcg ipratropimm bromide)+ Spacer, 12 to24 puffs, in adult patients with moderate-to-severe asthma crisis

    Study Document Trial synopsis 1012.32_CO english
  • COMBIVENT ® - Asthma
    Clinical Study Number 1012.36
    Study Indication Asthma
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase IV
    Study Title

    COMBIVENT vs. SALBUTAMOL in patients with metacholine-induced bronchospasm.

    Study Document Trial synopsis 1012.36_CO english
  • INFLAMMIDE ® - Asthma
    Clinical Study Number 1047.16
    Study Indication Asthma
    Product INFLAMMIDE ®
    Generic Name Budesonide
    Lab Code
    Clinical Phase IIIa
    Study Title

    A Randomised Double-Blind, Double-Dummy, Parallel Group Design.Twelve-week, Efficacy and Safety Study Comparing Respimat ® Budesonide (100 and 200 mcg, 2 puffs bid) with Turbohaler® Budesonide (200 mcg, 2 puffs bid) in Symptomatic Adult Moderate to Severe Asthmatics Requiring Inhaled Corticosteroids and Bronchodilator Therapy.

    Study Document Trial synopsis 1047.16 english
  • OXIVENT ® - Asthma
    Clinical Study Number 54.562
    Study Indication Asthma
    Product OXIVENT ®
    Generic Name Oxitropium bromide
    Lab Code
    Clinical Phase III
    Study Title

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

    Study Document Trial synopsis 54.562 english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.341
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II A
    Study Title

    A Randomised, Double-Blind, Placebo-Controlled, Crossover Efficacy and Safety Evaluation of 8-Week Treatment Periods of Two Doses [5 mcg (2 actuations of 2.5 mcg) and 10 mcg (2 actuations of 5 mcg)] of Tiotropium Inhalation Solution Delivered by the Respimat® Inhaler as Add-on Therapy in Patients with severe persistent Asthma

    Study Document Trial synopsis 205.341_CO english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.342
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIa
    Study Title

    A 16-week randomised, placebo-controlled, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of tiotropium inhalation solution delivered by the Respimat® inhaler (2 puffs of 2.5 µg once daily) with that of salmeterol from the hydrofluoroalkane metered dose inhaler (2 puffs of 25 µg twice daily) in moderate persistent asthma patients homozygous for B16-Arg/Arg

    Study Document Trial synopsis 205.342_DS_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.424
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A Phase II randomised, double-blind, placebo-controlled, incomplete crossover trial with 4-week treatment periods to evaluate efficacy and safety of tiotropium inhalation solution (doses of 1.25 µg, 2.5 µg and 5 µg) delivered via Respimat® inhaler once daily in the evening in adolescents (12 to 17 yrs old) with moderate persistent asthma

    Study Document Trial synopsis 205.424_DS_CO english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.417
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIa
    Study Title

    A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (5 µg/day) over 48 weeks as add-on controller therapy on top of usual care in patients with severe persistent asthma

    Study Document Trial synopsis 205.417_DS_DR english Combined analysis 205.416_205.417_DS_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.416
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIa
    Study Title

    A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (5 µg/day) over 48 weeks as add-on controller therapy on top of usual care in patients with severe persistent asthma

    Study Document Trial synopsis 205.416_DS_DR english Combined analysis 205.416_205.417_DS_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.420
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A Phase II, randomised, double-blind, placebo controlled, crossover efficacy and   safety comparison of tiotropium 5 µg administered once daily (in the evening)   and tiotropium 2.5 µg administered twice daily delivered by the Respimat®   inhaler for four weeks versus placebo in patients with moderate persistent   asthma

    Study Document Trial synopsis 205.420_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.380
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A Phase II randomised, double-blind, placebo controlled, crossover efficacy and safety comparison of three doses of tiotropium inhalation solution delivered via Respimat® inhaler (1.25, 2.5, and 5 µg once daily) versus placebo in patients with moderate persistent asthma

    Study Document Trial synopsis 205.380_DS_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.442
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III, randomised, double-blind, placebo-controlled, parallel-group trial to   evaluate efficacy and safety of tiotropium inhalation solution delivered via   Respimat® inhaler (2.5 µg and 5 µg once daily) compared to placebo over 12 weeks in mild persistent asthma

    Study Document Trial synopsis 205.442_CO english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.425
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A phase II randomised, double-blind, placebo-controlled incomplete crossover trial with 4-week treatment periods to evaluate efficacy and safety of tiotropium inhalation solution (doses of 1.25 µg, 2.5 µg, and 5 µg) delivered via Respimat® inhaler once daily in the evening in children 6 to 11 years old with moderate persistent asthma

    Study Document Trial synopsis 205.425_CO english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.418
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to   evaluate efficacy and safety of tiotropium inhalation solution delivered via  Respimat® inhaler (2.5 and 5 µg once daily) compared with placebo and  salmeterol HFA MDI (50 µg twice daily) over 24 weeks in patients with moderate persistent asthma

    Study Document Trial synopsis 205.418_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.419
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to   evaluate efficacy and safety of tiotropium inhalation solution delivered via  Respimat® inhaler (2.5 and 5 µg once daily) compared with placebo and  salmeterol HFA MDI (50 µg twice daily) over 24 weeks in patients with moderate persistent asthma

    Study Document Trial synopsis 205.419_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.464
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate safety and efficacy of tiotropium inhalation solution delivered via Respimat inhaler (2.5 and 5 µg once daily) compared with placebo over 52 weeks in patients with moderate to severe persistent asthma

    Study Document Trial synopsis 205.464_CO english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.444
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A phase III, randomised, double blind, placebo-controlled, parallel group study to assess the efficacy and safety over 48 weeks of orally inhaled Tiotropium bromide (2.5 and 5 µg once daily ) delivered by the Respimat® inhaler in adolescents (12 to 17 years old) with moderate persistent asthma.

    Study Document Trial synopsis 205.444_CO english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.441
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A randomised, double- blind, 2 way cross-over study to determine 24-hour FEV1-time profile of inhaled tiotropium, delivered via the Respimat inhaler, after 4 weeks of once daily [5 mcg in the evening (2 actuations of 2.5 mcg)] or twice daily [2.5 mcg in the morning and evening (2 actuations of 1.25 mcg)] administration in patients with moderate persistent asthma.

    Study Document Trial synopsis 205.441_CO english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.456
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma

    Study Document Trial synopsis 205.456_CO english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.443
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II/III
    Study Title

    A phase II/III, randomised, double-blind, placebo-controlled, parallel group trialto evaluate safety and efficacy of tiotropium inhalation solution (2.5 µg and5 µg) administered once daily in the afternoon via Respimat® Inhaler for12 weeks in patients 1 to 5 years old with persistent asthma

    Study Document Trial synopsis 205.443_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.446
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution (2.5 µg and 5 µg) delivered via Respimat® inhaler once daily in the evening over 12 weeks as add-oncontroller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma

    Study Document Trial synopsis 205.446_DR english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.445
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over 48 weeks in children (6 to 11 years old) with moderate persistent asthma

    Study Document Trial synopsis 205.445_DR english
  • STRIVERDI ® - Asthma
    Clinical Study Number 1222.4
    Study Indication Asthma
    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 (Bronchoprotection) and safety of a single dose of orally inhaled BI 1744 CL (2 µg, 5 µg, 10 µg, 20 µg) in patients with intermittent asthma

    Study Document Trial synopsis 1222.4_DS_CO english
  • STRIVERDI ® - Asthma
    Clinical Study Number 1222.6
    Study Indication Asthma
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase IIb
    Study Title

    Randomised, double-blind, placebo-controlled, parallel group study to assess the efficacy (bronchodilation) 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 asthma

    Study Document Trial synopsis 1222.6_DR english
  • STRIVERDI ® - Asthma
    Clinical Study Number 1222.27
    Study Indication Asthma
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase IIb
    Study Title

    A Randomised, Double-Blind, Placebo- and Active-Controlled, Incomplete Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Once Daily Treatment of 4 Doses of BI 1744 CL Inhalation Solution Delivered by the Respimat® in Patients with Asthma

    Study Document Trial synopsis 1222.27_DR english
  • STRIVERDI ® - Asthma
    Clinical Study Number 1222.29
    Study Indication Asthma
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase IIb
    Study Title

    Phase II, Randomised, Double-Blind, Cross-over Study to Compare the 24-hour FEV1-time Profile of Orally Inhaled Olodaterol, delivered with the Respimat® Inhaler, after 3 Weeks of Olodaterol Once Daily 5 µg [2 actuations of 2.5 µg], Twice Daily 2.5 µg [2 actuations of 1.25 µg] and Placebo or after 3 Weeks of Once Daily 10 µg [2 actuations of 5 µg], Twice Daily 5 µg [2 actuations of 2.5 µg] and Placebo Administration in Patients with Moderate to Severe Persistent Asthma

    Study Document Trial synopsis 1222.29_DR english
  • n/a - Asthma
    Clinical Study Number 352.2087
    Study Indication Asthma ; Healthy
    Product n/a
    Generic Name n/a
    Lab Code n/a
    Clinical Phase n/a
    Study Title

    An exploratory, prospective, non-interventional study comparing biomarker signatures between patients with asthma and healthy volunteers and to investigate biomarkers associated with known phenotypes across asthma severities

    Study Document Trial synopsis 352.2087 english
  • Tiotropium + BI 54903 - Asthma
    Clinical Study Number 1298.3
    Study Indication Asthma
    Product Tiotropium + BI 54903
    Generic Name Tiotropium + BI 54903
    Lab Code
    Clinical Phase II
    Study Title

    A single dose, randomised, placebo-controlled, double-blind, 5-way crossover (employing an incomplete block design), efficacy (including 24-h pulmonary function tests) and safety comparison of Tiotropium/BI 54903 FDC ethanolic inhalation solution via Respimat® (doses of 1.23 μg/363.6 μg, 2.46 μg/363.6 μg or 4.93 μg/363.6 μg) versus free combination of Tiotropium aqueous inhalation solution via Respimat® (doses of 0, 2.5 μg, 5 μg or 10 μg) plus BI 54903 ethanolic inhalation solution via Respimat® (dose of 363.6 μg ) in patients with asthma

    Study Document Trial statement 1298.3 english
  • SPIRIVA ® - Asthma
    Clinical Study Number 205.525
    Study Indication Asthma
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Specific Use-Result Surveillance of Spiriva Respimat in Asthmatics (patients with severe persistent asthma)

    Study Document Trial synopsis 205.525 english

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