Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)
Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients will receive the higher Aclidinium Bromide during the 40-week open label treatment period.
Timeline
- Start
- 2009-03
- Primary completion
- 2011-06
- Completion
- 2011-06
Outcome
Met primary endpoint
paper were significantly higher for aclidinium than for placebo (200 μg, 51 mL; 400 μg, 72 mL; both p < 0.05). PMID 24085591 ↗
registry analysis (superiority or other test); Placebo vs Aclidinium Bromide 200 μg; p = 0.019; Least Squares Mean Difference 0.051 (95% CI 0.01 to 0.09); ANCOVA NCT01045161 ↗
registry analysis (superiority or other test); Placebo vs Aclidinium Bromide 400 μg; p = 0.0012; Least squares mean difference 0.072 (95% CI 0.03 to 0.12); ANCOVA NCT01045161 ↗
registry analysis (superiority or other test); Placebo - Aclidinium Bromide 400 μg vs Aclidinium Bromide 200 μg - Aclidinium Bromide 400 μg; p = 0.0192; Least Squares Mean Difference 0.051 (95% CI 0.01 to 0.09); ANCOVA NCT01045161 ↗
registry analysis (superiority or other test); Placebo - Aclidinium Bromide 400 μg vs Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg; p = 0.0012; Least Squares Mean difference 0.072 (95% CI 0.03 to 0.12); ANCOVA NCT01045161 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aclidinium | Unknown | 200 ug | Inhaled |
| Subject | Aclidinium | Unknown | 400 ug | Inhaled |