Efficacy, Safety and Usability of BAI Containing Salmeterol/Fluticasone FDC in Persistent Asthma
23 Feb, 23


The need for coordinating actuation and inhalation with pressurized metered-dose inhalers (pMDI) and ensuring forceful inspiration in dry powder inhalers (DPI) are some of the limitations which can be overcome with breath-actuated inhalers (BAIs). Recently, a fixed dose combination BAI with salmeterol/fluticasone (SFC) has been introduced. Apart from efficacy and safety of the drug, the patient’s preference, acceptance of the device, and ease to use are crucial in the management of asthma.


This real-world study assessed the efficacy, safety, and usability of BAI containing fixed-dose combination (FDC) of SFC in Indian patients with persistent asthma (EVOLVE study).


Study Design

  • Prospective, open-label, non-comparative, multi-center, observational study.

Patient Profile

  • Asthmatic patients >12 years of age, treatment-naïve or uncontrolled asthma due to poor inhaler technique

Treatment Strategy

  • A total of 490 patients were prescribed SFC BAI 25/125 µg or 25/250 µg and were followed up at weeks 4, 8 and 12 after treatment initiation
  • Medical history, previous inhalers, physical examination, vital signs were recorded at screening.

End Points

Primary Endpoints

  • Change from baseline in the Asthma Control Questionnaire-6 (ACQ-6) score at week 12.

Secondary Endpoints

  • Change in ACQ-6 score at weeks 4 and 8
  • % Treatment responders
  • Change in peak expiratory flow rate (PEFR) at weeks 4, 8 and 12
  • Device usability at week 4

Safety Endpoints

  • Adverse events (AEs) recorded throughout study period (12 -weeks)
  • Serious adverse events (SAEs) recorded throughout study period (12 weeks)


  • Baseline characteristics of intention-to-treat (ITT) cohort were as follows
  • Mean age 43.2+16.4 years
  • 54.9% males
  • 94.9% were non-smokers
  • Treatment-naïve or newly diagnosed cases were 36.7% and 63.3% were receiving asthma treatment
  • About ~76% received SFC 250 and ~24% received SFC 125
  • A significant reduction in mean ACQ-6 score was noted from 2.2 ± 1.07 to 0.4 ± 0.49; p < 0.0001 at week 12, with a minimal clinically important difference of 0.5 from week 4 onwards
  • There was an increase in the proportion of well-controlled responders from week 4 to week 12 as seen in Figure 1.

Figure 1. % of well-controlled responders



  • PEFR improved by 82.5 ± 75.74 ml/min (p < 0.0001) at week 12
  • A majority of the patients as high as 91% preferred using this BAI over their previous inhaler device; 92.4% found it easy to use and 91.3% found it very easy to inhale from the device
  • This device was rated very high for usability, portability, patient confidence, and satisfaction.
  • The most common AE was respiratory tract infection in 0.6%


  • Treatment with salmeterol/fluticasone (SFC) fixed-dose combination administered through breath-actuated inhaler for 12 weeks resulted in consistent improvement in asthma control and lung function in Indian patients with persistent asthma
  • It was safe and well tolerated and preferred by majority of the patients over their previous inhaler and could be a new option in case of patients with poor inhaler techniques

Ther Adv Respir Dis. 2022; 16:1-13. Doi: 10.1177/17534666221137272