Status:
COMPLETED
High Dose Trial in COPD
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-84 years
Phase:
PHASE2
Brief Summary
The primary objective of this study was to compare the efficacy and safety of 200 μg and 400 μg of BEA 2180 BR to tiotropium 5 μg and placebo when each was delivered by the Respimat® Inhaler once dail...
Eligibility Criteria
Inclusion
- Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 \>=30% and \<= 60% of predicted normal and FEV1 \<=70% of FVC at the baseline PFTs at Visit 1 (at both timepoints).
- All patients must have an increase in FEV1 of at least 12% from baseline (th e -10 minute measurement) 45 min after inhalation of 80 ?g Atrovent MDI.
- Male or female patients 40 years of age or older.
- Smoker or ex-smoker with a history of more than 10 pack years.
- 1\. Patients with any other significant disease will be excluded. 2. Patients with a history of asthma or allergic rhinitis will be excluded.
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00128440
Start Date
August 1 2005
Last Update
October 29 2013
Active Locations (13)
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1
Boehringer Ingelheim Investigational Site
Lakewood, California, United States
2
Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
3
Boehringer Ingelheim Investigational Site
Pembroke Farms, Florida, United States
4
Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho, United States