Dose Finding Study in COPD
Status: | Completed |
---|---|
Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 40 - 83 |
Updated: | 12/30/2017 |
Start Date: | July 2005 |
A Randomized, Multiple-dose, Double-blind, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Study to Determine the Optimum Dose of BEA 2180 BR Delivered by the Respimat® Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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.
inhalation solut ion delivered by the Respimat ? inhaler once daily for four weeks in
patients with COPD.
1. 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).
2. 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.
3. Male or female patients 40 years of age or older.
4. 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.
We found this trial at
28
sites
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