NCT00528996.
Methods | Design: 24 weeks, multinational, randomised, double‐blind, parallel group study |
Participants |
Population: 2080 patients with COPD Inclusion criteria: FEV1 of < 80% of predicted, FEV1/FVC ≤ 70%, > 40 years of age, smoking history of > 10 pack‐years |
Interventions |
1. 50 mcg BEA 2180 once daily 2. 100 mcg BEA 2180 once daily 3. 200 mcg BEA 2180 once daily 4. Placebo once daily 5. Tiotropium bromide once daily Inhaler device: Respimat soft mist inhaler |
Outcomes | Primary: trough FEV1 response after 24 weeks Secondary: trough FEV1 response after 1, 2, 4, 8, 12, and 18 weeks, safety |
Notes |
Funding: Boehringer Ingelheim Study number: Boehringer Ingelheim 1205.14, ClinicalTrials.gov NCT00528996 |