Salmeterol/fluticasone (SFC) fixed-dose combination (FDC) treatment with a breath-actuated inhaler device for 12 weeks was associated with improved asthma control and lung function and was well tolerated in patients with asthma, according to study findings published in Therapeutic Advances in Respiratory Disease.
Researchers conducted the EVOLVE study to assess the efficacy, safety, and usability of administering SFC with Synchrobreathe (Cipla), a breath-actuated inhaler device. The 12-week, open-label, prospective, noncomparative study was conducted at 48 outpatient centers in India from December 2018 to May 2019.
Participants were all older than age 12 with a documented diagnosis of asthma. They were also treatment-naive or uncontrolled owing to poor inhaler technique associated with a previous device. Participants received SFC 25/125 µg or 25/250 µg via the Synchrobreathe device as part of their asthma management and were followed up at 4, 8, and 12 weeks after treatment initiation. The primary endpoint was a change from baseline in Asthma Control Questionnaire-6 (ACQ-6) score at week 12.
A total of 490 patients were in the intention-to-treat (ITT) and safety population and 476 in the modified ITT (mITT) group. The overall mean (SD) age of the cohort was 43.2 (16.4) years, and 269 (54.9%) were men. Participants had a mean asthma duration of 3.1 (6.9) years. In the ITT group, 371 patients received SFC 250 (75.7%) and 119 (24.3%) received SFC 125 via Synchrobreathe.
Over the 12-week study, participants’ mean ACQ-6 score significantly decreased — from 2.2 (1.1) at baseline to 0.4 (0.5) at week 12 (mean change, -1.9 (1.1); P <.0001) in the ITT group, with comparable trends observed in the mITT analysis. The minimal clinically important difference of 0.5 per the ACQ-6 was achieved at week 4. In subgroup analyses, statistically significant improvements in ACQ-6 scores were observed in patients who previously used dry powder inhalers, pressurized metered-dose inhalers (pMDIs), and SFC FDC with any inhaler device.
In the ITT group, the baseline peak expiratory flow rate increased by 35.1 (53.1) mL/min (P <.0001), 60.1 (65.5) mL/min (P <.0001), and 82.5 (75.7) mL/min (P <.0001) at weeks 4, 8, and 12, respectively, with similar findings observed in the mITT group.
SFC delivered via Synchrobreathe offers good efficacy and safety, and could have significant clinical implications for improving asthma control in real-world clinical settings.
A majority of participants (91%) reported that they preferred Synchrobreathe over their previous inhaler device, and 92.4% found it easy to use. A total of 15 adverse events and 2 serious adverse events were reported, with respiratory tract infection (0.6%) being the most frequently reported adverse event.
Study limitations include the open-label design with no comparator arm. Also, owing to the nonavailability of electronic medical records, the researchers were unable to establish a historical control. In addition, more than one-third of participants were treatment-naïve, and those with previous treatment may have been prescribed a higher dose of SFC, which could have affected outcomes.
“SFC delivered via Synchrobreathe offers good efficacy and safety, and could have significant clinical implications for improving asthma control in real-world clinical settings,” stated the investigators. “Overall, SFC Synchrobreathe is a new option for patients with asthma, including those who currently have poor inhaler techniques.”
Disclosure: This study was funded by Cipla Ltd, India. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.