Abstract

Background: Few dose ranging studies have investigated optimal dosing with inhaled corticosteroids in children with asthma.

Aims: To compare the efficacy and tolerability of fluticasone propionate 100 or 200 μg twice daily in children with moderate to severe asthma for one year.

Methods: One year, randomised, double blind, parallel group, multicentre study. Children aged 4–11 years (n = 528) with moderate to severe asthma who had previously received high dose inhaled corticosteroids were given fluticasone propionate 100 or 200 μg twice daily for the 52 week treatment period. Efficacy (exacerbations, lung function, and symptoms) and tolerability (adverse events and cortisol levels) were measured.

Results: There was a non-significant decreased risk of experiencing an exacerbation at any time with fluticasone propionate 200 μg twice daily compared with fluticasone propionate 100 μg twice daily. This difference reached significance among patients with more severe asthma (defined by previous inhaled corticosteroid dose >800 μg/day). Daily record card morning peak expiratory flow (PEF) in the total population improved significantly more with the higher dose of fluticasone propionate (between group difference, weeks 1–52: 11.4 l/min). Clinic visit mean PEF improved from baseline with both doses, but the response was significantly greater with the higher dose (between group difference, week 52: 17.8 l/min). Both doses were equally well tolerated and overnight urinary cortisol concentrations were unchanged or slightly increased during treatment with either dose.

Conclusion: This long term dose comparison study shows that treatment with fluticasone propionate 200 μg twice daily may offer benefits over a lower dose, particularly in children with more severe asthma.