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

Ther Adv Respir Dis. 2022 Jan-Dec:16:17534666221137272. doi: 10.1177/17534666221137272.

Abstract

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 < 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).

Keywords: ACQ-6 score; BAI; Seroflo; Synchrobreathe®; asthma; salmeterol/fluticasone.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Albuterol / adverse effects
  • Androstadienes
  • Asthma* / diagnosis
  • Asthma* / drug therapy
  • Bronchodilator Agents*
  • Double-Blind Method
  • Drug Combinations
  • Fluticasone-Salmeterol Drug Combination
  • Forced Expiratory Volume
  • Humans
  • Prospective Studies
  • Treatment Outcome

Substances

  • Bronchodilator Agents
  • Drug Combinations
  • Fluticasone-Salmeterol Drug Combination
  • Androstadienes
  • Albuterol

Associated data

  • CTRI/CTRI/2018/12/016629