drugset / Trial / NCT00891462
Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-up phone visit.
Timeline
- Start
- 2009-04
- Primary completion
- 2009-11
- Completion
- 2009-11
Outcome
Met primary endpoint
registry Placebo vs Aclidinium Bromide, 200µg; p <0.0001; Least Squares Mean Difference 0.086 (95% CI 0.05 to 0.13); ANCOVA NCT00891462 ↗
registry Placebo vs Aclidinium Bromide, 400µg; p <0.0001; Least Squares Mean Difference 0.124 (95% CI 0.08 to 0.16); ANCOVA NCT00891462 ↗
Publications
- McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.
- Kerwin EM, D'Urzo AD, Gelb AF, Lakkis H, Garcia Gil E, Caracta CF; ACCORD I study investigators. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD. 2012 Apr;9(2):90-101. doi: 10.3109/15412555.2012.661492. Epub 2012 Feb 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aclidinium | Unknown | 200 ug | Inhaled |
| Subject | Aclidinium | Unknown | 400 ug | Inhaled |