RT Journal Article
SR Electronic
T1 Efficacy and tolerability of aclidinium bromide/formoterol fumarate fixed-dose combination in patients with COPD: A 1-year study
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P2413
VO 44
IS Suppl 58
A1 Barry Make
A1 James Donohue
A1 Weily Soong
A1 Xiaoyun Zhong
A1 Anne Leselbaum
A1 Cynthia Caracta
YR 2014
UL http://erj.ersjournals.com/content/44/Suppl_58/P2413.abstract
AB BACKGROUND: In two 24-week placebo-controlled trials, twice-daily (BID) fixed-dose combination of aclidinium 400µg/formoterol 12µg (FDC12) was safe and effective in COPD patients.AIMS: To evaluate long-term efficacy and safety of FDC12 in patients with moderate to severe COPD.METHODS: In this 1-year, double-blind, parallel-group study, patients were randomized (2:1) to FDC12 or formoterol 12µg (FOR) BID. Lung function, rescue medication use, and treatment-emergent adverse events (TEAEs) were assessed.RESULTS: Mean baseline postbronchodilator FEV1 was 51.3% of predicted (ITT, n=581). In patients treated with FDC12, significant improvements from baseline in morning predose (trough) FEV1 were observed at each time point assessed vs FOR (Figure). In both treatment groups, average daily rescue medication use over the course of the study was reduced compared with baseline(FDC12, -1.8 puffs; FOR, -1.6 puffs). The percentage of patients with ≥1 TEAE was similar between FDC12 (71.4%) and FOR (65.7%) (safety population, n=590). The most common TEAEs (≥5% of patients in both groups) were sinusitis (5.1% vs 5.6%) and urinary tract infection (6.6% vs 5.6%).CONCLUSIONS: Sustained improvements in lung function were observed in patients with COPD treated with a fixed-dose combination of aclidinium/formoterol for 1 year compared with formoterol. FDC tolerability was comparable to formoterol alone.