Randomized, double-blind trial evaluating the efficacy and safety of fluticasone propionate and fluticasone propionate/salmeterol delivered via multidose dry powder inhalers in patients with persistent asthma aged 12 years and older

Abstract

Objective: To assess the efficacy and safety of fluticasone propionate (Fp) and Fp/salmeterol (FS) administered via a novel multidose dry powder inhaler (MDPI) that is easy to use correctly in asthma patients.

Methods: This phase-3, multicenter, double-blind, parallel-group study evaluated asthmatic patients (≥12 years of age) previously treated with either low- or mid-dose inhaled corticosteroids (ICSs) or ICS/long-acting beta agonists. After a 14- to 21-day run-in, patients were randomized to Fp MDPI 50 mcg, Fp MDPI 100 mcg, FS MDPI 50/12.5 mcg, FS MDPI 100/12.5 mcg, or placebo twice daily for 12 weeks. Change from baseline in forced expiratory volume in 1 second (FEV₁; primary endpoint) was evaluated at week 12, and serial spirometry was collected at day 1 and week 12 (subset of patients). Safety was assessed by adverse events (AEs).

Results: The full analysis and serial spirometry subset included 640 and 312 patients, respectively. At week 12, FS MDPI significantly improved FEV₁ from baseline at each dose vs corresponding Fp MDPI doses (p < 0.05). Change from baseline in FEV₁ for active treatment groups was significantly greater vs placebo (p < 0.05). After 12 weeks, serial spirometry was significantly greater at all time points in the FS MDPI groups vs corresponding Fp MDPI groups (p < 0.05). Improvements in serial spirometry on day 1 were maintained through week 12. AEs were similar across groups.

Conclusions: Pulmonary function was significantly improved with Fp MDPI and FS MDPI vs placebo and FS MDPI vs Fp MDPI. Active treatments had a safety profile comparable to placebo.

Trial registration: ClinicalTrials.gov NCT02139644.

Keywords: Adverse events; NCT02139644; device; inhaled corticosteroids; long-acting beta 2 agonists; pulmonary function; tolerability.