Patient-Reported Outcomes and Quality of Life Improved with Fluticasone Propionate and Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhalers Versus Placebo in Patients with Persistent Asthma

Abstract

Patient-reported outcomes, including quality of life, were evaluated in patients receiving fluticasone propionate (Fp) and fluticasone propionate/salmeterol (FS) via a novel multidose dry powder inhaler (MDPI). This phase 3, double-blind, parallel-group study (FSS-AS-301; NCT02139644) evaluated asthmatic patients (ages ≥12 years) using inhaled corticosteroids (ICS) or ICS/long-acting beta2-agonists. After a 14- to 21-day run-in during which patients received albuterol metered-dose inhaler for rescue, beclomethasone dipropionate metered-dose inhaler, 40 mcg twice daily (BID), and placebo MDPI BID, patients randomly received Fp MDPI 50 mcg, Fp MDPI 100 mcg, FS MDPI 50/12.5 mcg, FS MDPI 100/12.5 mcg, or placebo BID for 12 weeks. Efficacy and safety outcomes were previously reported. Patient-reported outcomes including asthma symptoms, rescue medication use, Asthma Quality of Life Questionnaire (AQLQ) scores (patients ≥18 years), and adverse events are reported. The full analysis and safety populations included 640 and 641 patients, respectively. All active treatments significantly improved asthma symptom scores (p<0.05) and significantly decreased rescue medication use (p<0.05) versus placebo over 12 weeks. Improvements in AQLQ from baseline to endpoint for active treatment groups were significantly greater versus placebo (p<0.05). AQLQ improvements from baseline achieved the minimal important difference (≥0.5) for all active treatment groups. Comparisons between Fp MDPI and FS MDPI were not significant for any assessed outcome except AQLQ for Fp MDPI 100 mcg versus FS MDPI 100/12.5 mcg (p<0.05). Adverse events were similar across groups. Low- and mid-dose Fp MDPI and FS MDPI significantly improved patient-reported outcomes and quality of life versus placebo.