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
| Autor: | Oliver Kornmann, Nadezda Kolosa, Biswajit Sen, Peter D'Andrea, Janos Mucsi, Lorraine Bandelli, Lisa C. Satlin |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male Pulmonary and Respiratory Medicine medicine.medical_specialty Time Factors Evening medicine.drug_class Mometasone furoate Quinolones Young Adult 03 medical and health sciences 0302 clinical medicine Quality of life Forced Expiratory Volume Surveys and Questionnaires Internal medicine Administration Inhalation medicine Clinical endpoint Humans 030212 general & internal medicine Asthma business.industry Middle Aged medicine.disease Drug Combinations Treatment Outcome 030228 respiratory system Asthma Control Questionnaire Indans Quality of Life Indacaterol Corticosteroid Female business Mometasone Furoate medicine.drug |
| Zdroj: | Respiratory Medicine. 161:105809 |
| ISSN: | 0954-6111 |
| Popis: | 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 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. |
| Databáze: | OpenAIRE |
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