Clinical efficacy of salmeterol/fluticasone compared with beclomethasone and fluticasone in children with moderate to severe bronchial asthma

Abstract

The aim was to compare effects of salmeterol/fluticasone propionate 50/100 μg bd (FSL) via Discus™ device with fluticasone propionate (FP) 100 pg bd via Dischaler or beclomethasone dipropionate (BDP 200 pg bid) via Dischaler in 12-week multtcentre randomised controlled trial involved 250 symptomatic children aged 4 to 10 yrs with moderate to severe asthma who had previosly received beclomethasone dipropionate less than 400 pg daily or cromones. The treatment effectiveness was assessed using a dairy card including measurement of asthma symptoms, peak expiratory flow (PEF), need in short-acting β₂-agonists, and a patient's consideration of treatment. The patients receiving FSL had significantly more symptom-free days (64.8 ± 21.8) versus the patients receiving FP (55 ± 23.9, p < 0,05) or BDP (52 ± 24.8, p < 0.05). The FSL patients had fewer days with rescue medication (10.2 ± 12.6) in comparison with the FP (24.9 ± 21.7, p < 0.001) and the BD patients (23.8 ±20.1 p < 0.001). During first 4 weeks of the treatment the morning PEF rates were slightly higher in the FSL patients (114 ±7 % pred.) versus the FP ones (107 ± 8 %) and BDP (106 ± 8 %). Significantly more FSL children and their parents were satisfied with the treatment (97 %) compared with 82 % of the FP and 68 % of the BDP patients (p < 0.001). Children did not have problems using the dry powder inhalers Discus and Dischaler. Adverse events were found in 4 FSL, 7 FP and 12 BDP patients (cold, cough after inhalation, sore throat). These effects were not severe. Thus, the combined treatment with low-dose FP and SL was more effective than two-fold higher dose BDP and the single therapy with low-dose FP in pediatric asthma patients.