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

(2018) 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, Journal of Asthma, 55:6, 640-650, DOI: 10.1080/02770903.2017 ABSTRACTObjective: 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 (FEV 1 ; 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 FEV 1 from baseline at each dose vs corresponding Fp MDPI doses (p < 0.05). Change from baseline in FEV 1 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.

Maintenance Therapy for Children and Adolescents with Asthma: Guidelines and Recommendations from the Emilia-Romagna Asthma (ERA) Study Group

“…In particular, the proportion of patients achieving at least 15% improvement in FEV 1 was higher in the ICS/LABA arms than in the ICS alone arms. No difference among groups was found in asthma symptoms score, average use of as needed albuterol/salbutamol, or adverse events [50].…”

Impact of inhaled fluticasone propionate/salmeterol on health-related quality of life in asthma: A network meta-analysis

“…The database searches yielded 1109 unique publications and six records were identified through other sources (Figure 1). Overall, 27 publications that described the results from 19 unique studies [37,38,[49][50][51][52][53][54][55][56][57][58][59][60][61][62][63][64][65][66][67][68] were included in the SLR, of which 15 studies [37,38, 49,50,52-55, 57-62, 55-68] were deemed suitable for inclusion in the base case NMA (Table 2).…”