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