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Effects of 2 Inhaled Corticosteroids on Growth
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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