Introduction: Indacaterol is a once-daily inhaled β 2 -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 FEV 1 , 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). Indacaterol 150μg Indacaterol 300μg Tiotropium Formoterol Salmeterol n No 438 455 270 276 181 ICS 308 398 145 280 152 Trough FEV1 (mL) No 180*** ‡ § 170*** ‡ § 140*** 120*** 120*** ICS 130*** ‡ § 170*** † ‡ § ¶ 120*** 80*** 80*** TDI score No 1.2*** 1.2*** 0.8** 0.9** 0.6* ICS 0.8*** 1.4*** ‡ ¶ 1.0*** 0.6* 1.2*** TDI OR No 2.17*** † 2.59*** † § 1.41 2.25*** 1.47 ICS 1.64** 2.84*** † ¶ 1.64* 1.88** 2.19*** SGRQ score <jats:td align="center" row
Dahl et al. (Thu,) studied this question.