Fluticasone for the treatment of symptomatic bronchial asthma in children treated with sodium cromogylate--a prospective, randomised trial

Abstract

Background: Children with persistent mild to moderate bronchial asthma require anti-inflammatory therapy. According to current treatment guidelines both sodium cromoglycate (SCG) and inhaled corticosteroids can be used. If children remain symptomatic despite regular SCG therapy, corticosteroids are the next therapeutic option.

Aims: To determine whether combined SCG and fluticasone (inhaled corticosteroid) therapy is of additional benefit in children who are symptomatic on SCG compared with simply switching to fluticasone.

Patients and methods: Children with mild or moderate persistent asthma aged 6 to 16 years who had been treated with inhaled SCG for at least 3 months prior to the study received either 2 mg SCG four times daily from a metered dose inhaler plus fluticasone propionate powder 50 microg b.i.d. from the Diskus inhaler (group FS) or fluticasone 50 microg b.i.d. only (group F). The randomised, controlled, parallel-group study had a 2 week run-in phase and an 8 week treatment period. Morning and evening peak expiratory flow rates (PEFR) were measured daily by patients and recorded in diaries. Asthma symptoms, use of rescue medication and spirometry were also documented.

Results: Paediatricians from 21 study centres recruited 124 children with asthma, of whom 104 fulfilled randomisation criteria and were allocated to study medication. Morning PEFR increased by 47 l/min and by 45 l/min after 8 weeks of treatment in groups F and FS, respectively. The adjusted difference between groups was 0.84% of predicted (95% CI, -7.3 to 5.6, p=0.80). Asthma symptoms and lung function also improved with no significant differences between treatment groups (p>0.24). Frequency and severity of adverse events was similar in both groups.

Conclusion: In children who are symptomatic while taking sodium cromoglycate four times daily, the combination of inhaled fluticasone and SCG is not superior to fluticasone alone. SCG can safely be withdrawn when commencing fluticasone, thus facilitating asthma treatment.