Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Summary

The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)

Timeline

Start

2013-09

Primary completion

2014-08

Completion

2014-08

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); Aclidinium Bromide / Formoterol Fumarate vs Salmeterol / Fluticasone; p <0.001; Mean Difference (Final Values) 0.093 (95% CI 0.063 to 0.123); MMRM NCT01908140 ↗

Publications

• Vogelmeier C, Paggiaro PL, Dorca J, Sliwinski P, Mallet M, Kirsten AM, Beier J, Seoane B, Segarra RM, Leselbaum A. Efficacy and safety of aclidinium/formoterol versus salmeterol/fluticasone: a phase 3 COPD study. Eur Respir J. 2016 Oct;48(4):1030-1039. doi: 10.1183/13993003.00216-2016. Epub 2016 Aug 4.

Drugs

Indications