Abstract
BACKGROUND: Inhalation therapy with corticosteroids and long-acting β(2)-agonists has been the mainstay of asthma management. However, choosing the correct inhaler technique is essential to effectively deliver the medication to the lungs to attain good asthma control. OBJECTIVE: This study aimed to evaluate asthma control and device usability with salmeterol/fluticasone fixed-dose combination (FDC) administered through Synchrobreathe(®), a breath-actuated inhaler (BAI), in Indian patients with persistent asthma (EVOLVE study). DESIGN: The present study was a prospective, open-label, non-comparative, multi-center, observational study. METHODS: The study enrolled 490 patients with documented diagnoses of asthma who were treatment-naive or uncontrolled due to poor inhaler technique associated with a previous device. The primary endpoint was a change from baseline in the Asthma Control Questionnaire-6 (ACQ-6) score at week 12. RESULTS: Mean ACQ-6 score reduced from 2.2 ± 1.07 (baseline) to 0.4 ± 0.49 (mean change: -1.9 ± 1.12, p < 0.0001) at week 12 in the intention-to-treat (ITT) population, and minimal clinically important difference of 0.5 was observed from week 4 onwards. Peak expiratory flow rate improved by 82.5 ± 75.74 ml/min (p < 0.0001) at week 12 in the ITT population. The proportion of well-controlled responders increased from 39.9% (week 4) to 77.1% (week 12). Most (91%) patients preferred the Synchrobreathe(®) and rated it very high for usability, portability, patient confidence, and satisfaction. Salmeterol/fluticasone FDC administered through Synchrobreathe(®) was well tolerated. CONCLUSION: Treatment with salmeterol/fluticasone FDC administered through Synchrobreathe(®) for 12 weeks persistently improved asthma control and lung function and was well tolerated. Most patients were satisfied with it and preferred Synchrobreathe(®) BAI over their previous device. REGISTRATION: The study was registered with the Clinical Trial Registry of India (CTRI/2018/12/016629).