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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00696020 |
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 mic tiotropium bromide solution for inhalation, delivered by the Respimat inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).
Condition | Intervention | Phase |
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Pulmonary Disease, Chronic Obstructive |
Drug: BI1744/Tiotropium bromide Drug: Tiotropium bromide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomised, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of 3 Doses of Orally Inhaled BI 1744 CL, Each in Fixed Dose Combination With 5 Microgram Tiotropium Bromide (Delivered by the Respimat Inhaler) Compared With 5 Microgram Tiotropium Bromide Monoproduct (Delivered by the Respimat Inhaler) in Patients With COPD |
Estimated Enrollment: | 350 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | January 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 and must meet the following spirometric criteria:
Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 greater or equal 30% of predicted normal and <80% of predicted normal and a post-bronchodilator FEV1 / FVC <70% at Visit 1
Exclusion Criteria:
Contact: Boehringer Ingelheim Study Coordinator | 800-542-6257 ext Option 4 | clintriage.rdg@boehringer-ingelheim.com |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1237.4, EudraCT No: 2007-005087-26 |
Study First Received: | June 10, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00696020 |
Health Authority: | Canada: Health Canada (TPD); Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration |
Lung Diseases, Obstructive Respiratory Tract Diseases Bromides Lung Diseases |
Respiration Disorders Chronic Disease Tiotropium Pulmonary Disease, Chronic Obstructive |
Respiratory System Agents Parasympatholytics Disease Attributes Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Cholinergic Agents |
Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents Central Nervous System Agents Anticonvulsants |