Effects of 2 inhaled corticosteroids on growth: Results of a randomized controlled trial

Objective: To compare the long-term effect of treatment with fluticasone propionate or beclomethasone dipropionate on growth in asthmatic children. Design: Prospective, multicenter, randomized, double-blind, parallel-group study. Setting: Children requiring regular treatment with inhaled corticosteroids and with a sexual maturity rating of Tanner stage 1 (prepubertal). Patients: Three hundred forty-three children aged 4 to 11 years with asthma. The growth population (excluding patients with protocol violations likely to affect growth measurements) included 277 patients. Interventions: Fluticasone propionate or beclomethasone dipropionate, both at a dosage of 200 μg administered twice daily via a dry powder inhaler (Diskhaler) for 12 months. Main Outcome Measures: Growth velocity, lung function, and serum and urinary cortisol levels. Results: The adjusted mean growth velocity in the fluticasone group was significantly greater than that in the beclomethasone group (5.01 [SE, 0.14] vs 4.10 [SE, 0.15] cm/y; difference, 0.91 cm; 95% confidence interval, 0.63-1.20 cm; P<.001). Both treatments improved lung function, with significant differences in favor of fluticasone. Adverse events were similar in both groups, and there were no significant differences in effect on serum and urinary cortisol levels. Conclusions: The more favorable risk-benefit ratio of fluticasone indicates that this agent is preferable to beclomethasone for the long-term treatment of children with asthma, especially if moderate doses are required.