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 - 31/01/20
, Janos Mucsi b , Nadezda Kolosa c , Lorraine Bandelli d , Biswajit Sen e , Lisa C. Satlin d , Peter D'Andrea d 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.
Le texte complet de cet article est disponible en PDF.Highlights |
• | What is already known about this topic? |
Many patients remain symptomatic despite receiving ICS monotherapy. The recent update in GINA 2019 recommends the addition of long-acting β2-agonist (LABA) to ICS monotherapy as the preferred controller and maintenance therapy in patients with inadequately controlled asthma.
• | •What does this article add to our knowledge? |
To our knowledge, this is the first study to compare a low-dose ICS/LABA FDC o.d. to low-dose ICS monotherapy in adult and adolescent patients with inadequately controlled asthma.
• | •How does this study impact current management guidelines? |
Once-daily, low-dose IND/MF can be a potential option for treatment of adult and adolescent patients with asthma who remain inadequately controlled on ICS (with/without LABA). Data from this study add to the existing evidence supporting, the efficacy of ICS/LABA over ICS alone and the efficacy of a once-daily combination of low-dose IND/MF 150/80 μg o.d., in patients with inadequately controlled asthma.
Le texte complet de cet article est disponible en PDF.Keywords : Asthma, Treatment, Long acting beta agonists, Inhaled corticosteroids
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Vol 161
Article 105809- janvier 2020 Retour au numéro
Article précédent
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