Lung function improvements following inhaled indacaterol/glycopyrronium/mometasone furoate are independent of dosing time in asthma patients: a randomised trial. Issue 2 (19th April 2021)

• Record Type: Journal Article
• Authors: Beier, Jutta; Watz, Henrik; Diamant, Zuzana; Hohlfeld, Jens M.; Singh, Dave; Pinot, Pascale; Jones, Ieuan; Tillmann, Hanns-Christian
• Is Part Of: ERJ open research. Volume 7:Issue 2(2021)
• Publication Date: 2021-04-19
• Subjects: Respiratory organs -- Diseases -- Periodicals; Respiration -- Periodicals; Respiration; Respiratory organs -- Diseases; Respiratory organs -- Diseases -- Treatment; Respiratory Tract Diseases; Electronic journals; Fulltext; Internet Resources; Periodicals; Periodical; 616.2005
• DOI: 10.1183/23120541.00425-2020
• Languages: English
• ISSNs: 2312-0541

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 β2 -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 (FEV1 ) 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 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 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. This randomised study found single-inhaler indacaterol/glycopyrronium/mometasone furoate improved respiratory parameters FEV1 and PEF in asthma patients, and showed similar efficacy when taken once daily in the morning or evening https://bit.ly/3fH0I1K