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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00452400 |
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy (how well it helps your breathing), safety evaluations and pharmacokinetic evaluations (the amount of the medication found in your blood).
Condition | Intervention | Phase |
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Pulmonary Disease, Chronic Obstructive Asthma |
Drug: BI 1744CL |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks of Treatment of Orally Inhaled BI 1744 CL (3 - 4 Doses) Delivered by the Respimat® Inhaler in Patients With COPD |
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, moderate to severe airway obstruction with a post-bronchodilator FEV1  30% of predicted normal and < 80% of predicted normal and a post-bronchodilator FEV1 / FVC < 70% at Visit 1
Exclusion Criteria:
Patients with any of the following conditions:
Patients with any of the following conditions:
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1222.5 |
Study First Received: | March 26, 2007 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00452400 |
Health Authority: | Canada: Therapeutic Products Directorate; Germany: BfArM Bundesinstitut fuer Arzneimittel und Medizinprodukte; Netherlands: Central Committee on Research Involving Human Subjects (CCMO); United States: Food and Drug Administration |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Asthma Chronic Disease Pulmonary Disease, Chronic Obstructive |
Disease Attributes Pathologic Processes |