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 the change in predose FEV1 from day 0 to day 84. Secondary efficacy endpoints included change in predose to 2-hours postdose FEV1 from day 0 to day 84, peak expiratory flow rate (PEFR), patient-reported outcomes, rescue-medication use and asthma exacerbations.

RESULTS:

In total, 211 patients were randomized and 210 completed the core phase; of these patients, 208 entered and 205 completed the extension phase of the study. Predose FEV1 increased from day 0 to day 84 [FP/FORM, 182 ml; 95% confidence interval (CI), 127, 236; FP/SAL, 212 ml, 95% CI, 160, 265] and FP/FORM was noninferior to FP/SAL: least squares (LS) mean treatment difference: -0.031 (95% CI, -0.093, 0.031; p = 0.026). Secondary efficacy analyses indicated similar efficacy with both therapies. There were no notable differences observed in the safety and tolerability profile between treatments. No safety concerns were identified with long-term FP/FORM therapy, and there was no evidence of an effect of FP/FORM on plasma cortisol.

CONCLUSIONS:

FP/FORM improved lung function and measures of asthma control with comparable efficacy to FP/SAL, and demonstrated a favourable safety and tolerability profile in children aged 4-12 years.

• Authors: Andrzej Emeryk, Rabih Klink, Tammy McIver, Prashant Dalvi
• Journal: Therapeutic advances in respiratory disease (Ther Adv Respir Dis) Vol. 10 Issue 4 Pg. 324-37 (08 2016) ISSN: 1753-4666 [Electronic] England
• PMID: 27185164 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial)
• Copyright: © The Author(s), 2016.

Chemical References

• Androstadienes
• Anti-Asthmatic Agents
• Bronchodilator Agents
• Drug Combinations
• Ethanolamines
• Fluticasone-Salmeterol Drug Combination
• fluticasone-formoterol
• Fluticasone
• Formoterol Fumarate

Topics

• Androstadienes (adverse effects, therapeutic use)
• Anti-Asthmatic Agents (adverse effects, therapeutic use)
• Asthma (drug therapy)
• Bronchodilator Agents (adverse effects, therapeutic use)
• Child
• Child, Preschool
• Drug Combinations
• Ethanolamines (adverse effects, therapeutic use)
• Female
• Fluticasone
• Fluticasone-Salmeterol Drug Combination (adverse effects, therapeutic use)
• Forced Expiratory Volume
• Formoterol Fumarate
• Humans
• Male
• Peak Expiratory Flow Rate
• Respiratory Function Tests
• Treatment Outcome