ABSTRACT
Inhaled corticosteroids are indicated in children who have more than mild persistent asthma. Fluticasone propionate is a newer corticosteroid agent with more potency compared with previous generations. However, still few dose ranging studies have investigated optimal dosing of inhaled corticosteroids particularly in children regarding the tolerability and safety of the drug. The primary purpose of this study is to compare and evaluate the efficacy and safety of Fluticasone to Beclomethosone in the treatment of childhood asthma that is unresponsive to non-steroidal medications and also in persistent, moderate and severe asthma. 70 children, aged 6 to 14 years, were enrolled in the open randomized trial of parallel group design. 52 children with moderate, severe or persistent asthma received Fluticasone 100microg twice daily for 12 weeks compared with 18 asthmatic children on Beclomethasone 200microg daily. The outcome was assessed by data on questionnaires, changes in clinical symptoms, results of peak flowmetery [PEFR]. More over safety was assessed by 24 hour urinary cortisol measuring at the beginning of the study and comparison of the data with urinary cortisol at the end of 12 weeks. Of 70 children, 13 [18.6%] had a history of contact with pets during their life. At the beginning of the study in Beclomethasone group the following signs and symptoms were found: cough 88.9%, post exercise cough 88.9%, dyspnea 66.7% and wheeze 72.2%; however, these figures were as follow in Fluticasone group: 75%, 76.9%, 46.2%, and 59.6%, respectively. After 3 months of therapy they have been changed as follow 16.7%, 11.1%, 11.1% and 16.7%, respectively, in Beclomethasone group and 15.4%, 11.1%, 1.9% and 3.8%, respectively, in Fluticasone group. Data showed a better improvement in clinical signs of patients with Fluticasone [p<0.05]. Pulmonary function test revealed a better lung function in Fluticasone group [p<0.05]. In addition 24 hour urinary cortisol level were measured at the beginning and after 12 weeks of therapy and it was within normal range for both drugs. Fluticasone was associated with better improvement in lung function and controlled asthma symptoms much better than Beclomethasone, therefore, it is efficient in the treatment of persistent, moderate and severe asthma in children