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Clinical Trial
. 2020 Jan:161:105809.
doi: 10.1016/j.rmed.2019.105809. Epub 2019 Nov 14.

Efficacy and safety of inhaled once-daily low-dose indacaterol acetate/mometasone furoate in patients with inadequately controlled asthma: Phase III randomised QUARTZ study findings

Oliver Kornmann  1 , Janos Mucsi  2 , Nadezda Kolosa  3 , Lorraine Bandelli  4 , Biswajit Sen  5 , Lisa C Satlin  6 , Peter D'Andrea  7
Affiliations
Free article
Clinical Trial

Efficacy and safety of inhaled once-daily low-dose indacaterol acetate/mometasone furoate in patients with inadequately controlled asthma: Phase III randomised QUARTZ study findings

Oliver Kornmann et al. Respir Med. 2020 Jan.
Free article

Abstract

Background: Global initiative for asthma (GINA) 2019 recommends adding a long-acting β2-agonist (LABA) to an inhaled corticosteroid (ICS) as a maintenance controller therapy in patients with inadequately controlled asthma. Indacaterol acetate (IND, a LABA) in combination with mometasone furoate (MF, an ICS) is under development for the treatment of these patients.

Objective: This phase III QUARTZ was a multicentre, randomised, double-blind, double-dummy and parallel-group study to assess the efficacy and safety of low-dose IND/MF 150/80 μg once daily (o.d.) versus MF 200 μg o.d. in adult and adolescent patients with inadequately controlled asthma.

Methods: Eligible patients (n = 802) were randomised (1:1) to receive either low-dose IND/MF 150/80 μg o.d. via Breezhaler® or MF 200 μg o.d. via Twisthaler® for 12 weeks. Primary endpoint was trough forced expiratory volume in 1 s (FEV1) and key secondary endpoint was Asthma Control Questionnaire (ACQ-7) treatment difference after 12-week treatment. Other secondary endpoints included ACQ-7 responder analysis, morning and evening peak expiratory flow, Asthma Quality of Life Questionnaire total score, rescue medication use, daily symptom score, nighttime awakenings and rate of exacerbations, evaluated over 12-week treatment. Safety was also assessed including serious asthma outcomes.

Results: Low-dose IND/MF significantly improved trough FEV1 (least squares mean treatment difference [LSMTD]: 0.182 L; p < 0.001) and ACQ-7 (LSMTD: -0.218; p < 0.001) versus MF at Week 12. Improvements in all other secondary endpoints favoured low-dose IND/MF. Safety was comparable.

Conclusion: These results support the use of low-dose IND/MF 150/80 μg o.d. as a potential therapy for adult and adolescent patients with inadequately controlled asthma.

Keywords: Asthma; Inhaled corticosteroids; Long acting beta agonists; Treatment.

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Conflict of interest statement

Declaration of competing interest OK's institution received fees for conducting the study as participating site; OK reports personal fees from Sanofi, Boehringer Ingelheim, Novartis, AstraZeneca and GlaxoSmithKline outside the submitted work. JM declares financial support from Novartis during the conduct of the study; from AstraZeneca, Chiesi, Sanofi-Aventis, GlaxoSmithKline, Boehringer-Ingelheim, MSD, TEVA, and ACTELION outside the submitted work. NK has nothing to disclose. LCS, BS, LB and PDA are Novartis employees.

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