An Open-Label, Single-Arm, Multicenter, Prospective, Post-Marketing Study to Evaluate the Effectiveness and Safety of Fluticasone Furoate/Vilanterol (FF/VI) Dry Powder Inhaler (DPI) in the Management of Asthma Patients (PROMISE-OD)

Background: A combination of inhaled corticosteroids (ICS) and long-acting β₂-agonists (LABA) is recommended for symptomatic asthma patients. Asthma control with single maintenance and reliever therapy (SMART) in patients remains poor with frequent nighttime awakenings, increased reliever use & severe exacerbations, including non-adherence. Once-daily FF/VI, an ultra LABA/ICS, has proven efficacy and safety in asthma with better adherence than multi-day regimens. Methods: This prospective, multi-center, post-marketing (PROMISE-OD) study evaluated FF/VI DPI (100/25 mcg or 200/25 mcg) over 12 weeks in symptomatic asthma patients (≥12 years) on conventional therapies. Results: Among 178 enrolled patients, 177 completed the study (53.9% females & mean age 44.8±15 years). Mean trough FEV1 improved by 180.5±810.7 ml (p=0.003) at week 4 & by 258.8±846.6 ml (p<0.0001) at week 12. The mean ACQ-5 score also reduced by -0.8±0.8 at week 4 and -1.3±0.9 at week 12 (p<0.0001). Adverse events occurred in 15.7% of patients, with no SAEs reported. Rescue medication was low (3.4% at week 4 & 5.1% at week 12). High patient and physician satisfaction was also observed. Conclusion: FF/VI DPI demonstrated significant improvements in lung function and asthma control with high patient satisfaction and a favorable safety profile, establishing it as a promising maintenance therapy for asthma management in Indian patients.