Efficacy and safety of fluticasone propionate/formoterol fumarate in pediatric asthma patients: a randomized controlled trial.

ABSTRACT:

Background

The efficacy and safety of fluticasone propionate/formoterol fumarate pressurized metered-dose inhaler (pMDI) (fluticasone/formoterol; Flutiform^®; 100/10 µg b.i.d.) was compared with fluticasone propionate (Flixotide^® Evohaler^® pMDI; 100 µg b.i.d.) and fluticasone/salmeterol (Seretide^® Evohaler^® pMDI; 100/50 µg b.i.d.) in a pediatric asthma population (EudraCT number: 2010-024635-16).

Methods

A double-blind, double-dummy, parallel group, multicenter study. Patients, aged 5-<12 years with persistent asthma ⩾ 6 months and forced expiratory volume in 1 s (FEV₁) ⩽ 90% predicted were randomized 1:1:1 to 12 weeks' treatment. The study objectives were to demonstrate superiority of fluticasone/formoterol to

SUBMITTER: Ploszczuk A 

PROVIDER: S-EPMC5985608 | biostudies-literature | 2018 Jan-Dec

REPOSITORIES: biostudies-literature