Abstract
Introduction: Indacaterol is a once-daily inhaled β2-agonist bronchodilator for COPD.
Aim: Pooled analysis to determine indacaterol efficacy in subgroups of COPD patients (pts) receiving ICS or not.
Methods: Data from 4088 pts with moderate-to-severe COPD in 3 randomized, double-blind, placebo-controlled studies of indacaterol 150 and 300μg od, tiotropium 18μg od (open-label), formoterol 12μg bid & salmeterol 50μg bid were pooled: 44% of pts had baseline ICS use, 56% no ICS use. Endpoints at 6 months: trough FEV1, transition dyspnoea index (TDI) and St George's Respiratory Questionnaire (SGRQ) total scores. The% of pts with clinically important difference in TDI and SGRQ were analysed as odds ratios (OR).
Results: Differences vs placebo (n=661 not on ICS, 524 on ICS) (*p<0.05, **p<0.01, ***p≤0.001) in pts not on ICS (“no”) or on ICS (“ICS”) (†p<0.05 vs tiotropium, ‡p<0.05 vs formoterol, §p<0.05 vs salmeterol, ¶p<0.05 vs indacaterol 150μg).
Conclusions: Indacaterol improved FEV1 and clinical outcomes after 6 months in patients not receiving ICS and those on ICS.
- © 2011 ERS