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.


METHODS
Prospective, multicenter, randomized, double-blind, parallel-group study.


METHODS
Children requiring regular treatment with inhaled corticosteroids and with a sexual maturity rating of Tanner stage 1 (prepubertal).


METHODS
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.


METHODS
Fluticasone propionate or beclomethasone dipropionate, both at a dosage of 200 microg administered twice daily via a dry powder inhaler (Diskhaler) for 12 months.


METHODS
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.
de Benedictis
F M
FM
Clinica Pediatrica, Policlinico Monteluce, 06100 Perugia, Italy. debened@unipg.it
Teper
A
A
Green
R J
RJ
Boner
A L
AL
Williams
L
L
Medley
H
H
D000730:Androstadienes / Q000494:pharmacology* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy / Q000378:metabolism; D001507:Beclomethasone / Q000494:pharmacology* / Q000627:therapeutic use; D001827:Body Height / Q000187:drug effects*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D005938:Glucocorticoids / Q000494:pharmacology* / Q000627:therapeutic use; D006801:Humans; D006854:Hydrocortisone / Q000378:metabolism; D008297:Male; D011446:Prospective Studies
D000730:Androstadienes; D005938:Glucocorticoids; D000068298:Fluticasone; D001507:Beclomethasone; D006854:Hydrocortisone