Efficacy and safety of aclidinium/formoterol fixed-dose combination in patients with COPD, stratified by ICS use
ED Bateman, K Chapman, S Rennard, L Rekeda, M Moya, EG Gil · Pneumologie · 2016 · Heft 02
Bibliografische Angaben
Zusammenfassung
Background: A secondary analysis of pooled data, stratified by concomitant inhaled corticosteroid (ICS) use, is presented from ACLIFORM (NCT01462942) and AUGMENT (NCT01437397), two Phase III, 24-week, randomised, double-blind studies of twice-daily (BID) aclidinium/formoterol (AB/FF) fixed-dose combination in patients (pts) with moderate to severe airflow obstruction. Methods: Pts received BID AB/FF 400/12 µg, AB/FF 400/6 µg, AB 400 µg, FF 12 µg or placebo (PB). Assessments: change from baseline in 1-hour morning post-dose and morning pre-dose (trough) forced expiratory volume in 1 second (FEV1) at Week 24, Tran…