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