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Results of a Randomized Controlled Trial

Fernando M. de Benedictis, MD; Alejandro Teper, MD; Robin J. Green, MD; Attilio L. Boner, MD; Lisa Williams, MSc; Hilary Medley, DipClinSci; for the International Study Group

Arch Pediatr Adolesc Med. 2001;155:1248-1254.

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.

From the Pediatric Division, University of Perugia, Perugia, Italy (Dr de Benedictis); Hospital de Niños "R. Gutiérrez," Buenos Aires, Argentina (Dr Teper); Sunninghill Hospital, Johannesburg, South Africa (Dr Green); the Pediatric Division, University of Verona, Verona, Italy (Dr Boner); and GlaxoSmithKline, Uxbridge, England (Mss Williams and Medley).

Corresponding author and reprints: Fernando M. de Benedictis, MD, Clinica Pediatrica, Policlinico Monteluce, 06100 Perugia, Italy (e-mail: debened{at}unipg.it).

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