Department of Pediatrics, NRITLD, Shaheed Beheshti University of Medical Sciences and Health Services, TEHRAN-IRAN.
Background: Inhaled corticosteroids are indicated in children who have mild persistent asthma. Fluticasone propionate is a newer corticosteroid agent with higher potency compared with previous generations. However, still few dose-ranging studies have been investigated for optimal dosing of inhaled corticosteroids particularly in children with regard to the tolerability and safety of the drug. The primary purpose of this study was to compare and evaluate the efficacy and safety of fluticasone with beclomethosone in the treatment of childhood asthma unresponsive to non-steroidal medications and also in persistent, moderate and severe asthma. Materials and Methods: Seventy children, aged 6 to 14 years were enrolled in an open randomized trial with a parallel group design. Fiftytwo children with moderate, severe or persistent asthma received fluticasone 100 µg twice daily for 12 weeks compared with 18 asthmatic children on beclomethasone 200 µg daily. The outcome was assessed by data on questionnaires, changes in clinical symptoms, and results of peak flowmetery (PEFR). Moreover, safety was assessed by 24 hour urinary cortisol measurement at the beginning of the study and comparison of the data with urinary cortisol at the end of 12 weeks. Results: A total of 70 children between 6 to 14 years (33 girls and 37 boys) were randomized to start treatment with fluticasone or beclomethasone. From 70 children 13(18.6%) had a history of contact with pets during their life. At the beginning in beclomethasone group: 88.9% had cough, 88.9% had post exercise cough, 66.7% had dyspnea and 72.2% had wheezing. In Fluticasone group: 75% had cough,76.9% had post exercise cough, 46.2% had dyspnea and 59.6% had wheezing. After 3 months of therapy in beclomethasone group: cough was seen in 16.7%, post exercise cough in 11.1%, dyspnea in 11.1%, wheezing in 16.7% and in fluticasone group: cough in 15.4%, post exercise cough in 11.1%, dyspnea in 1.9% and wheezing in 3.8%.Data showed a better improvement in clinical signs of patients with fluticasone (p <0.05). Pulmonary function tests revealed better lung function in fluticasone group (p <0.05). In addition, 24 hours urinary cortisol level was measured at the beginning and after 12 weeks of therapy and it was within the normal range for both drugs. Conclusion: Fluticasone produced significantly greater improvement in lung function and control of asthma symptoms compared to beclomethasone and is efficient in the treatment of persistent, moderate and severe asthma in children. In addition these improvements were achieved with no greater degree of cortisol suppression compared with beclomethasone. (Tanaffos 2007; 6(1): 29-35)