Therapeutic Advances in Respiratory Disease (Dec 2022)

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

  • 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

DOI
https://doi.org/10.1177/17534666221137272
Journal volume & issue
Vol. 16

Abstract

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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).