Lung function improvements following inhaled indacaterol/glycopyrronium/mometasone furoate are independent of dosing time in asthma patients: a randomised trial.
ERJ Open Res
; 7(2)2021 Apr.
Article
em En
| MEDLINE
| ID: mdl-33898609
ABSTRACT
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 ß2-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 (150/50/80â
µg) dosed morning and evening versus placebo in patients with mild-moderate asthma. The primary end-point was weighted mean forced expiratory volume in 1â
s (FEV1) over 24â
h following 14â
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 18-72â
years; 21 male, 16 female) 34 completed all three treatment periods. At screening, median (range) pre-bronchodilator FEV1 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 FEV1 (area under the curve from 0 to 24â
h) by 610â
mL (90% CI 538-681 mL) and 615â
mL (90% CI 544-687 mL), respectively, versus placebo. Mean PEF over 14â
days increased by 70.7â
L·min-1 (90% CI 60.5-80.9 L·min-1) following a.m. dosing, and by 59.7â
L·min-1 (90% CI 49.5-69.9â
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 24â
h, irrespective of a.m. or p.m. dosing, in patients with mild-moderate asthma.
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Ano de publicação:
2021
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Article