Overview

Dose Finding Study in COPD

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Tiotropium Bromide
Criteria
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.