TY - JOUR T1 - Fluticasone propionate/formoterol fumarate (FLUT/FORM) combination therapy has comparable efficacy to fluticasone propionate/salmeterol xinafoate (FLUT/SAL) in paediatric patients with asthma JF - European Respiratory Journal JO - Eur Respir J VL - 38 IS - Suppl 55 SP - p4822 AU - Tammy McIver AU - Andrzej Emeryk AU - Rabih Klink AU - Birgit Schwab Y1 - 2011/09/01 UR - http://erj.ersjournals.com/content/38/Suppl_55/p4822.abstract N2 - Background: A new asthma therapy combining FLUT/FORM in a single aerosol inhaler (flutiform®) has been shown to have comparable efficacy to FLUT/SAL (single inhaler) in adults. This study compared these combinations in a paediatric population.Methods: Patients aged 4-12yrs (N=211) with mild/moderate persistent asthma were randomized 1:1 to 12 weeks of treatment with FLUT/FORM (100/10μg) or FLUT/SAL (100/50μg), twice daily, in an open-label, parallel-group, multicentre study. The primary endpoint was change in mean pre-dose FEV1 values from Day 0 to Day 84. Secondary endpoints included change in mean FEV1 values from Day 0 pre-dose to Day 84 120mins post-dose, discontinuations due to lack of efficacy and time to onset of action.Results: FLUT/FORM was non-inferior to FLUT/SAL regarding change in LS mean pre-dose FEV1: +182mL for FLUT/FORM and +212mL for FLUT/SAL (treatment difference: -31mL; 95% CI: -0.093, 0.031; per protocol set (PPS), FLUT/FORM: n=102; FLUT/SAL: n=99; Day 84). Non-inferiority of FLUT/FORM to FLUT/SAL was also demonstrated for post-dose FEV1 values: change in LS mean post-dose FEV1 was +308mL for FLUT/FORM and +325mL for FLUT/SAL (treatment difference: -17mL. 95% CI: -0.089, 0.055; PPS, n: as above). No patients discontinued due to lack of efficacy. No relevant differences in time to onset of action were evident between the two treatment groups.Conclusion: Fluticasone/formoterol was comparable to fluticasone/salmeterol with regard to pre-dose and post-dose FEV1 values and discontinuations due to lack of efficacy. FLUT/FORM and FLUT/SAL had comparable efficacy and safety profiles. ER -