Lung Function Improvements with Twice-Daily Aclidinium/formoterol Fixed-Dose Combination in Two 24-Week Studies in Patients with COPD

BACKGROUND: Fixed-dose combinations (FDC) of different bronchodilators improve lung function through complementary mechanisms. AIM: To assess bronchodilation with an FDC comprising aclidinium bromide and formoterol fumarate in patients with moderate to severe COPD. METHODS: In 2 phase 3 trials, ACLIFORM COPD (S1) and AUGMENT COPD (S2), patients were randomized to 24 weeks of twice-daily inhaled aclidinium/formoterol 400µg/12µg (FDC 400/12), 400µg/6µg (FDC 400/6), aclidinium 400µg (ACL), formoterol 12µg (FOR), or placebo (PBO). Lung function coprimary outcomes were change from baseline to week 24 for 1-hr morning postdose FEV 1 (FDC vs ACL) and morning predose (trough) FEV 1 (FDC vs FOR). RESULTS: Baseline mean FEV 1 were 1.38L (S1) and 1.36L (S2) (54.2% and 53.5% predicted). At the first time point assessed, treatment with either FDC resulted in significant improvements in the coprimary endpoints that were generally maintained at study end (Table). Each FDC showed clinically significant improvements in both endpoints vs PBO that were evident as early as 5 min postdose on day 1 (range: 100–128 mL, p CONCLUSIONS: Fixed-dose combination of aclidinium/formoterol showed rapid and sustained improvements in bronchodilation compared with each monotherapy and placebo, with numerically greater improvements observed with FDC 400/12 vs FDC 400/6.