Abstract:
BACKGROUND:Smoking continues to be a major risk factor for COPD and may impact the efficacy of COPD treatments, with guidelines supporting the crucial importance for current smokers of smoking cessation. A post-hoc analysis of the FLIGHT1 and FLIGHT2 studies assessed the impact of smoking status on the efficacy and safety of indacaterol/glycopyrrolate (IND/GLY) 27.5/15.6 μg twice daily versus its monocomponents or placebo in patients with COPD. METHODS:This post-hoc analysis of pooled data from the replicate, 12-week, placebo-controlled FLIGHT1 and FLIGHT2 studies compared the efficacy and safety of IND/GLY with that of IND, GLY, and placebo in patients with moderate-to-severe COPD. Baseline data from 2038 patients were pooled and grouped by smoking status (52% were current smokers and 48% were ex-smokers). The effects of treatment on lung function, patient-reported outcomes (PROs), and safety were evaluated by baseline smoking status. RESULTS:Treatment with IND/GLY resulted in significant improvements in lung function measurements compared with placebo, irrespective of smoking status. Improvements in St George's Respiratory Questionnaire and transition dyspnea index were significantly greater than placebo in both current and ex-smokers, whereas changes in COPD assessment test were significant only among current smokers. Improvements in lung function and PROs were greater with IND/GLY compared with its monocomponents in current and ex-smokers. The incidences of AEs and SAEs were similar between current and ex-smokers. CONCLUSIONS:IND/GLY demonstrated significant improvements in lung function and PROs, independent of baseline smoking status. The safety profile of IND/GLY did not differ between current and ex-smokers.
journal_name
Respir Medjournal_title
Respiratory medicineauthors
Tashkin DP,Goodin T,Bowling A,Price B,Ozol-Godfrey A,Sharma S,Sanjar Sdoi
10.1016/j.rmed.2019.07.019subject
Has Abstractpub_date
2019-08-01 00:00:00pages
113-120eissn
0954-6111issn
1532-3064pii
S0954-6111(19)30243-4journal_volume
155pub_type
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