COMPARISON OF FLUTICASONE PROPIONATE AND SODIUM CROMOGLYCATE FOR THE TREATMENT OF CHILDHOOD ASTHMA (AN OPEN PARALLEL-GROUP STUDY)

Inhaled corticosteroids are highly effective in the treatment of asthm a at all ages and their use in younger children is increasing. As conc erns exist about the long-term systemic side-effects of high dose inha led corticosteroids, current guidelines continue to recommend sodium c romoglycate (SCG) as first line regular medication for children with f requent symptoms. Few published studies have compared the safety and e fficacy of inhaled corticosteroids with SCG in children. This study co mpares SCG with the new inhaled corticosteroid, fluticasone propionate (FP), which has theoretical advantages over other currently available corticosteroids due to its negligible oral bioavailability. This was a randomized, open, multi-centre, parallel group comparison of 50 mu g FP twice daily and 20 mg SCG four times daily over 8 weeks, preceded by a 2-week baseline period. Sixty-two general practices and two hospi tal centres enrolled 225 asthmatic children aged 4-12 years (110 recei ved FP; 115 received SCG). Outcome measures improved in both groups, w ith a significant difference in favour of FP for the key variables of mean morning and evening % predicted PEFR and % of symptom-free days a nd nights. No significant difference was observed for FEV(1), or relie f medication use. Two children taking FP and 10 children taking SCG wi thdrew because of adverse events. This study showed that low dose FP w as effective and superior to SCG in young children with mild-moderate asthma. Safety studies of longer duration are needed before changing t he current recommendations for inhaled corticosteroid therapy.