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

oleh: Santhalingam Balamurugan, Dalal Sonia, Deshmukh Vikrant, Khanra Monotosh, Sundar Raj Shyam, Akhtar Shamim, Kumar Vinay, Nandagopal Velayuthaswamy, Ahmed Masood, Gupta Manohar Lal, Godse Ajay, Chhowala Sushmeeta, Lopez Meena, Sawant Sandesh, Jadhav Sonali, Vaidya Abhijit, Gogtay Jaideep

Format: Article
Diterbitkan: SAGE Publishing 2022-12-01

Deskripsi

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).