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. 2014 Jul 21;2014(7):CD009285. doi: 10.1002/14651858.CD009285.pub3

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