Value through Innovation27 July 2016

Clinical Study Results

  • 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 ® - 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 ® - 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 ® - Cystic Fibrosis
    Clinical Study Number 205.338
    Study Indication Cystic Fibrosis
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase I
    Study Title

    A randomized, double-blind within dose, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of increasing single and multiple doses (28-day dosing) of tiotropium bromide administered once daily via the Respimat® device in cystic fibrosis patients

    Study Document Trial synopsis 205.338_CO english
  • SPIRIVA ® - Cystic Fibrosis
    Clinical Study Number 205.339
    Study Indication Cystic Fibrosis
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A randomised, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat® device for 12 weeks in patients with cystic fibrosis

    Study Document Trial synopsis 205.339_DS_CO 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 ® - 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 ® - 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 ® - 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 ® - 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 ® - 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 ® - 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 ® - Cystic Fibrosis
    Clinical Study Number 205.438
    Study Indication Cystic Fibrosis
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis

    Study Document Trial synopsis 205.438_DS_CO 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 ® - 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 ® - 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 ® - 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 ® - Renal Insufficiency
    Clinical Study Number 205.134
    Study Indication Renal Insufficiency
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase I
    Study Title

    The Pharmacokinetics, Safety and Tolerability of Tiotropium (4.8 mcg, single i.v. dose) in Outpatients with Renal Impairment in Comparison to Healthy Subjects (Open Label, Group Comparison, Monocenter Study).

    Study Document Trial synopsis 205.134_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 ® - Healthy
    Clinical Study Number 205.138
    Study Indication Healthy
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase I
    Study Title

    A single increasing dose tolerance study after ocular administration of tiotopium (single doses: 0.02 - 0.4 mcg) in healthy male volunteers (randomised, placebo-controlled, double-blind, parallel groups).

    Study Document Trial synopsis 205.138 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 ® - Healthy
    Clinical Study Number 205.222
    Study Indication Healthy
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase I
    Study Title

    The effect of concomitant cimetidine p.o. 400 mg t.i.d. and p.o. ranitidine 300 mg once daily on single-dose pharmacokinetics of Tiotropium (14.4 mcg) given intravenously over 15 minutes in healthy male and female subjects of 50 - 65 years (randomized, open label, two independent two-fold cross-over).

    Study Document Trial synopsis 205.222 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 ® - Healthy
    Clinical Study Number 205.239
    Study Indication Healthy
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, two-way cross-over study to investigate the pharmacokinetic and pharmacodynamic effects of a single additional dose of 500 mg ipratropium bromide unit dose vial inhaled via nebuliser versus placebo after 19 days of treatment with tiotropium inhalation capsules 18 mg q.d. in male healthy volunteers.

    Study Document Trial synopsis 205.239 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 ® - 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 ® - 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 ® - 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 ® - 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 ® - 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
  • 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
  • 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
  • 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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