Pulmonary Disease, Chronic Obstructive
Conditions
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 daily for four weeks in patients with COPD.
Interventions
DRUGBEA 2180 BR
DRUGtiotropium
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to 84 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 | baseline to 24 hours post drug administration |
| forced expiratory volume in one second (FEV1) area under curve 3 to 6 hours (AUC0-6h) after four weeks of treatment. | after 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| FEV1 and FVC peak response after 0 and 4 weeks | after 0 and 4 weeks |
| FVC AUC0-6h after 0 and 4 weeks | after 0 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 |
| Physician's Global Evaluation | 4 weeks |
| All adverse events | 28 weeks |
| Pulse rate and blood pressure (seated) recorded in conjunction with spirometry for the first three hours following dosing | 28 weeks |
| 12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose on Day 1 and 29 of each treatment period (Visits 2-9) | 28 weeks |
| COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest | 4 weeks |
| Trough FVC response after 4 weeks | after 4 weeks |
Countries
United States
Outcome results
None listed