Abstract
BACKGROUND: India bears a significant burden of asthma, and asthma in India is characterized by high mortality rates. Poor adherence to treatment guidelines is observed. Several inhaled corticosteroid (ICS) with long-acting beta (β) 2 agonist (LABA) combinations are commercially marketed in India, formoterol fumarate-fluticasone propionate being one of them. Real-world Indian studies on fluticasone-formoterol from India are scarce. This study aims to evaluate the effectiveness and safety of formoterol fumarate (6 µg) and fluticasone propionate (250 µg) administered through a dry powder inhaler (DPI) or metered-dose inhaler (MDI) in Indian asthma patients.
MATERIALS AND METHODS: This 24-week prospective, multicenter study (CTRI/2023/08/056250) evaluated Formoflo 250 (formoterol fumarate 6 µg with fluticasone propionate 250 µg) transcaps (DPI), and Formoflo 250 transhaler (MDI) in adults aged 18-65 years. The primary endpoint was the mean change in trough forced expiratory volume in 1 second (FEV1) at week-24. Secondary endpoints included changes in trough forced vital capacity (FVC), asthma control test (ACT), and asthma quality of life questionnaire (AQLQ) scores. Safety was assessed through adverse events (AEs) and asthma exacerbations, with appropriate statistical analyses conducted on the modified intention-to-treat (mITT) population.
RESULTS: A total of 503 patients were enrolled, with 495 included in the mITT analysis and all 503 in the safety analysis. At week-24, a mean increase of 312.2 ± 121.1 mL was observed in trough FEV1, while trough FVC improved by 279.3 ± 147.3 mL (p < 0.0001). The mean ACT score increased by 11.6 ± 3.7 (p < 0.0001), while the mean AQLQ score improved by 2.5 ± 1.2 (p < 0.0001) at week-24. Adverse events were reported in 7.0% of patients, primarily mild, with no serious AEs or fatalities. The findings were consistent across both Formoflo DPI and MDI formulations.
CONCLUSION: The combination of formoterol fumarate and fluticasone propionate significantly improved lung function, asthma control, and quality of life, demonstrating marked effectiveness and safety with both DPI and MDI in Indian asthma patients.