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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
---|---|
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00528996 |
The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.
Condition | Intervention | Phase |
---|---|---|
Pulmonary Disease, Chronic Obstructive |
Drug: BEA 2180 BR Drug: tiotropium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multinational, Randomised, Double-Blind, Placebo- and Active-Controlled, Parallel Group Efficacy and Safety Comparison Over 24 Weeks of Three Doses (50µg, 100µg, 200µg) of BEA 2180 BR to Tiotropium 5µg, Delivered by the Respimat Inhaler and Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD) |
Estimated Enrollment: | 2048 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All patients must have a diagnosis of chronic obstructive pulmonary disease (P95 4381) and must meet the following spirometric criteria:
Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 (post-bronchodilator, 30 minutes post salbutamol/albuterol) <80% of predicted normal and FEV1 less than or equal to 70% of FVC at the PFTs at Visit 1 (screening).
Exclusion Criteria:
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1205.14, 2007-007946-42 |
Study First Received: | September 12, 2007 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00528996 |
Health Authority: | Canada: Therapeutic Products Directorate branch of Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Drug Organisation; Hungary: National Institute of Pharmacy (OGYI), H-1051 Budapest; Korea, Republic of: KOREA Food and Drug Administration (KFDA); Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS); Poland: CEBK, Warsaw; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Spain: Spanish Medicines and Healthcare Products Agency; Taiwan: Department of Health, Executive Yuan, Taiwan; United States: Food and Drug Administration |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders |
Chronic Disease Tiotropium Pulmonary Disease, Chronic Obstructive |
Respiratory System Agents Parasympatholytics Disease Attributes Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents |
Cholinergic Agents Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |