Value through Innovation27 July 2016

Clinical Study Results

  • 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 ® - 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 ® - 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 ® - 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 ® - 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 ® - 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
  • 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 ® - Healthy
    Clinical Study Number 1222.47
    Study Indication Healthy
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of 10 µg olodaterol (solution for inhalation administered   with the Respimat®) at steady state alone or in combination with multiple doses  of 400 mg q.d. ketoconazole (tablet) in healthy male and female volunteers (an   open-label, fixed sequence, Phase I study)

    Study Document Trial synopsis 1222.47_DR english
  • STRIVERDI ® - Healthy
    Clinical Study Number 1222.48
    Study Indication Healthy
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of 10 µg olodaterol (solution for inhalation administered   with the Respimat®) at steady state alone or in combination with multiple doses  of 400 mg q.d. fluconazole (hard capsule) in healthy male and female volunteers   (an open label, fixed sequence, Phase I study)

    Study Document Trial synopsis 1222.48 english
  • STRIVERDI ® - Healthy
    Clinical Study Number 1222.1
    Study Indication Healthy
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase Ia
    Study Title

    A randomised, double-blind, placebo-controlled (within dose groups) study to assess safety, tolerability and pharmacokinetics of single rising inhaled doses (0.5 µg to 70 µg administered with the Respimat®) of BI 1744 CL in healthy male and female volunteers

    Study Document Trial synopsis 1222.1_CO english
  • STRIVERDI ® - Healthy
    Clinical Study Number 1222.2
    Study Indication Healthy
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase Ib
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising inhalative doses (2.5 µg, 10 µg, and 30 µg) of BI 1744 CL for 14 days in healthy male and female volunteers (double-blind, randomised, placebo controlled [at each dose level] study)

    Study Document Trial synopsis 1222.2 english
  • STRIVERDI ® - Healthy
    Clinical Study Number 1222.7
    Study Indication Healthy
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising doses of 0.5 mcg, 2.5 mcg, 5 mcg, 10 mcg, 15 mcg, 20 mcg, 25 mcg and 30 mcg BI 1744 CL (calculated as free base) given as intravenous infusion over 30 minutes to healthy male subjects. A single-centre, single-blind, placebo-controlled, randomised study.

    Study Document Trial synopsis 1222.7 english
  • STRIVERDI ® - Healthy
    Clinical Study Number 1222.8
    Study Indication Healthy
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, placebo-controlled, six-way crossover study including an open-label positive control (moxifloxacin) to assess the influence of via Respimat inhaled BI 1744 CL (single doses of 10 mcg, 20 mcg, 30 mcg and 50 mcg) on the QT/QTc interval of the ECG in healthy male and female volunteers.

    Study Document Trial synopsis 1222.8 english
  • STRIVERDI ® - Healthy
    Clinical Study Number 1222.9
    Study Indication Healthy
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the metabolism and pharmacokinetics of 20 µg (calculated as free base) [14C] BI 1744 CL administered as a 3-hour infusion and 40 µg (calculated as free base) [14C] BI 1744 CL administered as an oral solution

    Study Document Trial synopsis 1222.9_CO english
  • STRIVERDI ® - Healthy
    Clinical Study Number 1222.19
    Study Indication Healthy
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, single-blind, placebo-controlled (within dose groups) study to assess safety, tolerability and pharmacokinetics of single rising peroral doses (15, 30, 40 mcg free cation) BI 1744 CL in healthy volunteers.

    Study Document Trial synopsis 1222.19_CO english
  • STRIVERDI ® - Healthy
    Clinical Study Number 1222.20
    Study Indication Healthy
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, safety and tolerability of a single dose of BI 1744 CL (20mcg administered with the Rewpimat Inhalter) in patients with mild and moderate hepatic impairment (Child Pugh classification A and B) in comparison to a single dose of BI 1744 CL (30mcg administerd with the Respimat Inhaler) in subjects with normal hepatic function in a monocentric, open label, parallel group Phase I trial

    Study Document Trial synopsis 1222.20_CO english
  • STRIVERDI ® - Healthy
    Clinical Study Number 1222.21
    Study Indication Healthy
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, placebo-controlled (within a dose group) study to evaluate safety, tolerability and pharmacokinetics of multiple rising inhalative doses (5 mcg, 10 mcg and 20 mcg) of BI 1744 CL for 14 days in healthy male volunteers

    Study Document Trial synopsis 1222.21_CO english
  • STRIVERDI ® - Healthy
    Clinical Study Number 1222.35
    Study Indication Healthy
    Product STRIVERDI ®
    Generic Name Olodaterol
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, safety and tolerability of single dose of BI 1744 CL (30mcg administered with the Respimat Inhaler) in patients with severe renal impairment in comparison to subjects with normal renal function in a monocentric, open-label, parallel group Phase I trial

    Study Document Trial synopsis 1222.35_CO 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

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