ATLANTA, GA—Quality of life and patient-reported outcomes (PROs) significantly improved among patients using low- and mid-dose fluticasone propionate (Fp) or fluticasone propionate/salmeterol (FS) administered with a multidose dry powder inhaler (MDPI), according to authors of the Phase 3, double-blind, placebo-controlled FSS-AS-301 study (NCT02139644). The findings were reported at the 2017 AAAAI Annual Meeting.
“Fp MDPI and FS MDPI significantly improved PROs and health-related quality of life compared with placebo over the 12-week treatment period as measured by total daily asthma symptom scores, daily albuterol/salbutamol use, and AQLQ(S) [Standardized Asthma Quality of Life Questionnaire] scores,” reported lead study author Gordon Raphael, MD, of the Bethesda Allergy, Asthma and Research Center, in Bethesda, MD.
A total of 640 asthmatic patients aged ≥12 years old participated in the study. Patients were using inhaled corticosteroids (ICS) or ICS/long-acting β2-agonists. Patient-reported outcomes included adverse events, asthma symptoms, rescue medication, and for patients ≥18 years old, AQLQ scores.
The study’s first, run-in phase involved a 14 to 21 day period during which patients received albuterol metered-dose inhaler (MDI) as needed for rescue, beclomethasone dipropionate MDI 40mcg twice daily, or placebo MDPI twice daily. Patients were then randomly assigned to receive Fp MDPI 50mcg, Fp MDPI 100mcg, FS MDPI 50/12.5mcg, FS MDPI 100/12.5mcg, or placebo twice daily, for a second, 12-week phase of the study.
“All active treatments significantly improved asthma symptom scores (P<0.05) versus placebo over 12 weeks and significantly decreased rescue medication use (P<0.05) versus placebo over 12 weeks,” the authors reported. “Improvements in AQLQ from baseline to endpoint for active treatment groups were significantly greater versus placebo (P<0.05).”
Outcomes were statistically similar for Fp MDPI and FS MDPI.