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)

TL;DR

A study found that a once-daily asthma medication improved lung function and asthma control with high satisfaction and few side effects.

Contribution

This study evaluates the effectiveness and safety of a once-daily asthma medication in a real-world setting.

Findings

FF/VI DPI improved lung function (FEV1) significantly over 12 weeks.

Asthma control scores improved, with high patient and physician satisfaction.

Low adverse event rate and minimal rescue medication use were observed.

Abstract

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.

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