Indacaterol-glycopyrronium-mometasone furoate combination consistently shows lung function benefits in patients with asthma

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 treatment of asthma. We report data from an active-comparator-controlled (B2208) and a placebo-controlled (B2209) study.

Methods: Both studies had a randomized, double-blind, 3-period crossover design. B2208 included 116 adult patients with moderate-to-severe asthma (on LABA and medium- or high-dose ICS, FEV1%predicted < 80%), comparing IND/GLY/MF o. d. 150/50/160 µg (highdose ICS) and 150/50/80 µg (medium-dose ICS) with twice-daily (b. i. d.) high-dose salmeterol/fluticasone (S/F [LABA/ICS], 50/500 µg) over 21 days. B2209 included 37 adult patients with mild-to-moderate asthma (on low- or medium-dose ICS, FEV1%predicted ≥ 60 −< 100%), comparing medium-dose IND/GLY/MF with placebo over 14 days.

Results: In B2208, both high- and medium-dose IND/GLY/MF showed superior treatment effect (mean difference) vs. S/F on trough FEV1 (124 mL [95%CI: 86, 161] and 105 mL [95% CI: 67, 143], respectively) and FVC (AUC 0 – 24h) (104 mL [95%CI: 66, 142] and 86 mL [95% CI: 48, 125], respectively [all p < 0.0001]). In B2209, mean improvement in trough FEV1 by IND/GLY/MF was 544 mL vs. placebo (95% CI: 460, 628 mL; p < 0.0001), with a mean increase of 304 mL in FVC (AUC 0 – 24 h) vs. placebo (95% CI: 243, 364 mL; p < 0.0001).

Conclusion: IND/GLY/MF o. d. consistently demonstrates clinically and statistically significant improvements in lung function compared with high-dose S/F b. i. d. and placebo in patients with mild, moderate and severe asthma in two separate Phase II studies.