12 / 48 wk Pivotal PFT vs PBO in COPD II
NCT00782509 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 644
Last updated 2014-06-27
Summary
This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD).
Conditions
- Pulmonary Disease, Chronic Obstructive
Interventions
- DRUG
-
Olodaterol (BI 1744)
Comparison of low and high doses on efficacy and safety in COPD patients
- DRUG
-
Olodaterol (BI 1744)
Comparison of low and high doses on efficacy and safety in COPD patients
- DRUG
-
Olodaterol (BI 1744) placebo inhaled orally once daily from the Respimat inhaler
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-02-28
- Primary Completion
- 2010-09-30
Countries
- United States
- China
- Germany
- Taiwan
Study Locations
More Related Trials
-
Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease
NCT01809262 ·Status: COMPLETED ·Phase: PHASE2
-
Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease
NCT01040689 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Japanese Patients With COPD
NCT00824382 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry II
NCT01040793 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of 4 Weeks of Treatment With Orally Inhaled BI1744/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00720499 ·Status: COMPLETED ·Phase: PHASE2
-
Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)
NCT01040403 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Safety and Efficacy of 4 Doses of BI 1744 CL Delivered Via the Respimat in Patients With Asthma.
NCT01013753 ·Status: COMPLETED ·Phase: PHASE2
-
A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease
NCT01040728 ·Status: COMPLETED ·Phase: PHASE3
-
Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
NCT00932646 ·Status: COMPLETED ·Phase: PHASE3
-
Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) Taking Salmeterol Xinafoate/Fluticasone Propionate Combination
NCT01321463 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry I
NCT01040130 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Doses of RV1729 for 28 Days in Patients With COPD
NCT02140346 ·Status: COMPLETED ·Phase: PHASE1
-
Comparison of Safety and Efficacy of Berodual® Administered Via the Respimat® Device With That Administered Via the Metered Dose Inhaler (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT02173782 ·Status: COMPLETED ·Phase: PHASE3
-
Combination of Orally Inhaled BI1744CL/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease ( COPD)
NCT00696020 ·Status: COMPLETED ·Phase: PHASE2
-
Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
NCT00931385 ·Status: COMPLETED ·Phase: PHASE3
-
To Evaluate the Effect of Inhaled Medication Together With Exercise and Activity Training on Exercise Capacity and Daily Activities in Patients With Chronic Lung Disease With Obstruction of Airways
NCT02085161 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetics and Safety of BI 1744 CL Plus Tiotropium Bromide in Chronic Obstructive Pulmonary Disease (COPD)
NCT02231177 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD
NCT02937584 ·Status: COMPLETED ·Phase: PHASE3
-
To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
NCT03081247 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
NCT01033487 ·Status: COMPLETED ·Phase: PHASE2
-
Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease
NCT01559116 ·Status: COMPLETED ·Phase: PHASE3
-
Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Tiotropium Bromide
NCT01543919 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Finding Study in COPD
NCT00122434 ·Status: COMPLETED ·Phase: PHASE2
-
24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003, Open-Label Spiriva® Respimat® as an Active Control, and Placebo
NCT02347072 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
NCT02643082 ·Status: COMPLETED ·Phase: PHASE3