Pulmonary Disease, Chronic Obstructive
Conditions
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.
Interventions
DRUGBEA 2180 BR
DRUGtiotropium
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to 83 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trough forced expiratory volume (FEV1) response after four weeks of treatment. | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Trough FVC response after 1, 2 and 4 weeks | after 1, 2 and 4 weeks |
| FEV1, FVC AUC0-6h and peak response after 0, 1, 2 and 4 weeks | after 0, 1, 2 and 4 weeks |
| Individual FEV1 and FVC measurements at each time point | 4 weeks |
| Weekly mean pre-dose morning and evening PEFR | 4 weeks |
| Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol] | 4 weeks |
| COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest) | 4 weeks |
| Trough FEV1 response after 1 and 2 weeks | after 1 and 2 weeks |
| All adverse events | 7 weeks |
| Pulse rate and blood pressure (seated) recorded in conjunction with spirometry up to the three hour pulmonary function test (PFT) | 4 weeks |
| 12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose (Visits 2 and 5) | 4 weeks |
| drug plasma concentrations | 4 or 7 weeks |
| drug urine concentrations | 4 or 7 weeks |
| Physician's Global Evaluation | 4 weeks |
Countries
Belgium, Netherlands, United States
Outcome results
None listed