Status:
COMPLETED
Dose Finding Study in COPD
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-83 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to determine the optimum dose of BEA 2180 BR inhalation solut ion delivered by the Respimat ? inhaler once daily for four weeks in patients with COPD.
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 :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
389 Patients enrolled
Trial Details
Trial ID
NCT00122434
Start Date
July 1 2005
Last Update
December 28 2017
Active Locations (43)
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1
UAB Lung Health Center
Birmingham, Alabama, United States
2
Vapahcs 111P
Palo Alto, California, United States
3
Boehringer Ingelheim Investigational Site
San Diego, California, United States
4
GLAHS Sepulveda
Sepulveda, California, United States