Effectiveness and safety of salmeterol/fluticasone fixed-dose combination delivered through Synchrobreathe® in patients with asthma: the real-world EVOLVE study

Background: Inhalation therapy with corticosteroids and long-acting β2-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