Article Text

PDF
P228 Efficacy And Safety Of Fluticasone Propionate/formoterol In Paediatric Patients With Asthma
  1. A Ploszczuk1,
  2. M Bosheva2,
  3. K Spooner3,
  4. T McIver3,
  5. S Dissanayake3
  1. 1Department of Allergology and Internal Medicine, University of Bialystok, Bialystok, Poland
  2. 2MHAT "Sveti Georgi", Plovdiv, Bulgaria
  3. 3Mundipharma Research Ltd, Cambridge, UK

Abstract

Background Fluticasone propionate (FP) and formoterol (FORM) have been combined in a single inhaler (FP/FORM;flutiform ®) for the treatment of adolescents and adults with asthma. This study assessed the efficacy and safety of FP/FORM in paediatric asthma patients.

Methods A total of 512 patients aged 5 to <12yrs were randomised 1:1:1 to 12 weeks of treatment with either FP/FORM (100/10 µg BID), FP (100 µg BID) or fluticasone propionate/salmeterol (FP/SAL) (100/50 µg BID) in a double-blind, parallel group, multicentre study. The objectives were to demonstrate superiority of FP/FORM to FP and non-inferiority to FP/SAL. The primary endpoint was the change from predose FEV1 at baseline to 2-hour postdose FEV1 over the 12 weeks. The two key secondary endpoints were FEV1 AUC0–4h at Week 12 and change from pre-dose FEV1 over the 12 weeks.

Results FP/FORM was superior to FP for change from predose FEV1 at baseline to 2-hour postdose FEV1 (treatment difference = 0.07 L; 95% CI: 0.03, 0.11; p < 0.001) and FEV1 AUC0–4h at Week 12 (treatment difference = 0.09 L; 95% CI: 0.04, 0.13; p < 0.001). FP/FORM was non-inferior to FP/SAL for change from predose FEV1 at baseline to 2-hour postdose FEV1 (treatment difference = -0.00 L; 95% CI: -0.04, 0.04; p < 0.001), AUC0–4h at Week 12 (treatment difference = 0.01 L; 95% CI: -0.03, 0.06; p < 0.001) and change from predose FEV1 (treatment difference = -0.02 L; 95% CI: -0.06, 0.02; p < 0.001). The safety and tolerability profiles of all treatments were similar.

Conclusion In children 5 to <12yrs with asthma, FP/FORM was superior to FP, and non-inferior to FP/SAL for improvements in lung function, with a similar tolerability profile to both FP and FP/SAL.

Disclaimer Acknowledgement: Reproduced with permission of the European Respiratory Society: Eur Resp J September 2014; 44, Suppl. 58: In Press

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.