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Once-daily asthma treatment should prevent night-time deterioration, irrespective of the time of dosing. IND/GLY/MF, a fixed-dose combination of inhaled indacaterol acetate (IND, long-acting β 2 -agonist (LABA)), glycopyrronium bromide (GLY, long-acting muscarinic antagonist) and mometasone furoate (MF, inhaled corticosteroid (ICS)) delivered by Breezhaler, is indicated in adult asthma patients inadequately controlled on LABA/ICS.  A randomised, double-blind, placebo-controlled, three-period, crossover, phase II study was performed to investigate the bronchodilator effect of IND/GLY/MF (150/50/80 μg) dosed morning and evening  versus  placebo in patients with mild-moderate asthma. The primary end-point was weighted mean forced expiratory volume in 1 s (FEV 1 ) over 24 h following 14 days of IND/GLY/MF dosed a.m. and p.m.  versus  placebo. Secondary end-points included the effect of dosing time on peak expiratory flow (PEF) and safety/tolerability.  Of 37 randomised patients (age 18–72 years; 21 male, 16 female) 34 completed all three treatment periods. At screening, median (range) pre-bronchodilator FEV 1  was 75.8% (60–96%). Patients were using stable low- (83.8%) or medium-dose (16.2%) ICS. Morning and evening dosing of IND/GLY/MF improved FEV 1  (area under the curve from 0 to 24 h) by 610 mL (90% CI 538–681 mL) and 615 mL (90% CI 544–687 mL), respectively,  versus  placebo. Mean PEF over 14 days increased by 70.7 L·min −1  (90% CI 60.5–80.9 L·min −1 ) following a.m. dosing, and by 59.7 L·min −1  (90% CI 49.5–69.9 L·min −1 ) following p.m. dosing of IND/GLY/MF  versus  placebo. IND/GLY/MF demonstrated a safety profile comparable with placebo.  Once-daily inhaled IND/GLY/MF was well tolerated and provided sustained lung function improvements over 24 h, irrespective of a.m. or p.m. dosing, in patients with mild–moderate asthma.

erj open research

Lung function improvements following inhaled indacaterol/glycopyrronium/mometasone furoate are independent of dosing time in asthma patients: a randomised trial