Efficacy and safety of aclidinium/formoterol fixed-dose combination in patients with moderate to severe airflow obstruction, stratified by severity

Background: This was a secondary pooled analysis of ACLIFORM (NCT01462942) and AUGMENT (NCT01437397), two 24-week, randomised, double-blind, Phase III studies of twice-daily (BID) aclidinium/formoterol (AB/FF) fixed-dose combination in patients with COPD and moderate to severe airflow obstruction. Pooled data were stratified by airflow obstruction severity. Methods: Patients received AB/FF 400/12 µg, AB/FF 400/6 µg, AB 400 µg, FF 12 µg or placebo (PBO), BID. Assessments: change from baseline in morning pre-dose (trough) and 1-hour morning post-dose forced expiratory volume in 1 second (FEV1) at Wk 24 and Transit…