PT  - JOURNAL ARTICLE
AU  - Anna Ploszczuk
AU  - Miroslava Bosheva
AU  - Kay Spooner
AU  - Tammy McIver
AU  - Sanjeeva Dissanayake
TI  - Efficacy and safety of fluticasone propionate/formoterol in paediatric patients with asthma
DP  - 2014 Sep 01
TA  - European Respiratory Journal
PG  - P1167
VI  - 44
IP  - Suppl 58
4099  - http://erj.ersjournals.com/content/44/Suppl_58/P1167.short
4100  - http://erj.ersjournals.com/content/44/Suppl_58/P1167.full
SO  - Eur Respir J2014 Sep 01; 44
AB  - 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 (100/10µg BID), FP 100µg BID) or fluticasone propionate/salmeterol (FP/SAL) (100/50µg 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 = 0.07L; 95%CI: 0.03, 0.11; P<0.001) and FEV1 AUC0-4h at Week 12 (treatment difference = 0.09L; 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 = -0.00L; 95%CI: -0.04, 0.04; P<0.001), AUC0-4h at Week 12 (treatment difference = 0.01; 95%CI: -0.03, 0.06; P<0.001) and change from predose FEV1 (treatment difference = -0.02L; 95%CI: -0.06, 0.02; P<0.001). The safety and tolerability profiles of all treatments were similar.Conclusions: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.Sponsor: Mundipharma Research Ltd.