Comparison of clinical effects of beclomethasone dipropionate & budesonide in treatment of children with mild persistent asthma: A double-blind, randomized, controlled study

BACKGROUND & OBJECTIVES: Various inhaled corticosteroids (ICSs) are available to control the symptoms of asthma. Although beclomethasone dipropionate (BDP) and budesonide (BUD) are one of the oldest ICSs, their wide availability and low cost make them attractive options in developing countries. Due to lack of consensus on which of the two drugs is better for controlling mild persistent asthma, we undertook this study to compare the efficacy of these two drugs by measuring the change in percentage predicted forced expiratory volume in one second (FEV(1)) from baseline in children with mild persistent asthma. METHODS: A double-blind, randomized, parallel group study was conducted in children 7-15 yr of age with newly diagnosed asthma. Of the 85 cases of mild persistent asthma, 42 received BUD while 43 received BDP at a dose of 400 µg/day using pressurized metered-dose inhaler with valved spacer for two months. The outcomes measured were change in FEV(1), symptom scores and side effects. RESULTS: There was a significant (P < 0.05) improvement in FEV(1) in BUD group (98.43 ± 4.63%) than in BDP group (95.65 ± 5.66%) at the end of two months of treatment. The mean symptom scores in BUD group (0.28 ± 1.22) and BDP group (0.43 ± 1.52) were comparable after two months. No side effects were seen in either group. INTERPRETATION & CONCLUSIONS: FEV(1) was significantly greater in BUD group than BDP group. Improvement in symptoms and incidence of side effects were similar. Our findings indicate that both BDP and BUD can be used effectively in the management of children with mild persistent asthma. [CTRI No: CTRI/2013/03/003495].