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.

BACKGROUND: Global initiative for asthma (GINA) 2019 recommends adding a long-acting ß2-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.

Improvement In Self-Reported Physical Functioning With Tiotropium/Olodaterol In Central And Eastern European COPD Patients.

Background: Reduced physical activity is associated with increased morbidity and mortality in patients with COPD. Studies suggest that treatment with the long-acting muscarinic antagonist tiotropium and the long-acting ß2-agonist olodaterol increases exercise capacity. This study assessed the effects of a fixed-dose combination (FDC) of tiotropium/olodaterol (delivered via Respimat®) on physical functioning in patients with stable COPD in a "real-world setting". Methods: An international, open-label, single-arm, non-interventional study conducted in nine countries measuring changes in self-reported physical functioning in COPD patients treated with tiotropium/olodaterol 5/5 µg FDC for approximately 6 weeks. The primary endpoint was therapeutic success, defined as a minimum 10-point increase in the 10-question Physical Functioning Questionnaire (PF-10) score. Secondary endpoints included absolute change in PF-10 from Visit 1 to Visit 2, patient general condition (measured by Physician's Global Evaluation score) and patient satisfaction with the treatment and device (assessed by Patient Satisfaction Questionnaire at the end of the study period). Results: Therapeutic success was observed in 67.8% of 7218 patients (95% CI 66.7, 68.8) in the final analysis set after approximately 6 weeks of treatment with tiotropium/olodaterol. Mean change in PF-10 score between Visit 1 and Visit 2 was 16.6 points (95% CI 16.2, 17.0). Therapeutic success was 64.3% (95% CI 63.0-65.6%) in patients with infrequent (≤1) and 76.1% (95% CI 74.3-77.9%) in patients with frequent (≥2) exacerbations (p<0.0001). Patient general condition improved as indicated by an improvement in Physician's Global Evaluation scores between visits. Most patients were very satisfied or satisfied with tiotropium/olodaterol treatment in general (81%), reported inhalation satisfaction (85%), and satisfactory handling of the device (84%). 1.3% of patients reported an investigator-defined drug-related adverse event. Conclusion: Treatment with tiotropium/olodaterol led to an improvement in self-reported physical functioning in patients with COPD.