A 12-week open-label, randomized, controlled trial and 24-week extension to assess the efficacy and safety of fluticasone propionate/formoterol in children with asthma.

ABSTRACT:

Objectives

The present study was conducted to assess the efficacy, safety and tolerability of fluticasone propionate/formoterol fumarate combination therapy (FP/FORM; Flutiform®) compared with fluticasone propionate/salmeterol xinafoate (FP/SAL; Seretide® Evohaler®) in children with asthma.

Methods

This was an open-label, randomized, controlled, phase III trial and extension. Patients aged 4-12 years with reversible asthma [% predicted forced expiratory volume in 1 second (FEV1) 60-100%; documented reversibility of ⩾15% in FEV1] were randomized to receive FP/FORM (100/10 µg b.i.d.) or FP/SAL (100/50 µg b.i.d.) for 12 weeks. Eligible patients completing the 12-week core phase entered a 24-week extension phase with FP/FORM (100/10 µg b.i.d.). The primary efficacy endpoint was

SUBMITTER: Emeryk A 

PROVIDER: S-EPMC5933684 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature