Lung function normalization with indacaterol/glycopyrronium/mometasone furoate in patients with asthma

Abstract

Introduction: Indacaterol (IND, LABA), glycopyrronium (GLY, LAMA) and mometasone furoate (MF, ICS) have been formulated as a once-daily (o.d.) fixed-dose combination therapy (IND/GLY/MF) delivered via the Breezhaler® device for the treatment of asthma. We report data from two Phase II studies (B2208 and B2209). Methods: Both studies had a randomized, double-blind, 3-period crossover design. B2208 included 116 adult patients with moderate-to-severe asthma (on LABA/ICS, FEV1 %predicted B2209 included 37 adult patients with mild-to-moderate asthma (on low- or medium-dose ICS, FEV1 %predicted ≥60− Results: In B2208, 44.6% and 47.3% of patients on high- or medium-dose IND/GLY/MF, respectively, achieved near-normal lung function (FEV1 [AUC0–24h] ≥80% of predicted normal) compared with 34.4% with S/F (p In B2209, 48.4% of patients on medium-dose IND/GLY/MF achieved normal lung function (FEV1 [AUC0–24h] ≥90% of predicted normal) vs 6.7% on placebo. The odds ratio (OR) (95% CI) of being rescue medication free was 1.87 (1.03, 3.41) and 1.44 (0.80, 2.59) when treated with high- or medium-dose IND/GLY/MF, respectively, compared with S/F (B2208). The OR (95% CI) was 11.51 (3.77, 35.14) for medium-dose IND/GLY/MF vs placebo (B2209). Conclusion: Patients with asthma are more likely to achieve normal or near-normal lung function and to remain rescue medication free with IND/GLY/MF compared with high-dose S/F or placebo.