Long-term treatment with fluticasone propionate/formoterol fumarate (FLUT/FORM) combination therapy is well-tolerated and provides sustained effectiveness in paediatric patients with asthma

Abstract

Background: A new asthma therapy combining FLUT/FORM in a single aerosol inhaler (flutiform®) has been shown to be well-tolerated and effective in adolescents and adults over a 9 month period. This study examined the long-term safety and efficacy of FLUT/FORM in paediatric patients.

Methods: Patients aged 4-12yrs (N = 208) with mild/moderate persistent asthma received FLUT/FORM 100/10μg b.i.d. in a 24-week open-label, multicentre extension study. In the core study, patients had received 12 weeks of treatment with FLUT/FORM (100/10μg b.i.d.) or fluticasone propionate/salmeterol xinafoate (FLUT/SAL; 100/50μg b.i.d.). Safety was evaluated on the basis of adverse events (AEs), laboratory parameters, height and weight. The main efficacy endpoint was the change in mean pre-dose FEV₁ values during the extension study (from Day 84 to Day 252).

Results: The overall rate of AEs during the extension study (43.8%; n=208) was comparable to the core study treatment groups (FLUT/FORM: 44.2%, n=104; FLUT/SAL: 43.3%, n=104). The majority of AEs were mild, not considered study treatment related and did not result in withdrawal. Mean and median plasma cortisol values remained stable during the extension study, with no evidence of effects on normal growth (mean increases in weight and height were 2.1kg and 2.8cm respectively). Mean pre-dose FEV₁ increased by 105mL from 1.859L at the start of extension phase.

Conclusion: Long-term fluticasone/formoterol combination therapy has a good safety and tolerability profile and provides sustained effectiveness in paediatric patients with mild/moderate persistent asthma.