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Effects of 2 inhaled corticosteroids on growth: results of a randomized controlled trial
F M de Benedictis1, A Teper, R J Green
1Clinica Pediatrica, Policlinico Monteluce, 06100 Perugia, Italy. debened@unipg.it
Insights
Fluticasone propionate showed significantly greater growth velocity in children with asthma compared to beclomethasone dipropionate. This suggests fluticasone is a preferred long-term treatment option for pediatric asthma management.
Area of Science:
- Pediatric Pulmonology
- Pharmacology
- Clinical Research
Background:
- Inhaled corticosteroids (ICS) are standard therapy for persistent asthma in children.
- Long-term effects of different ICS on growth are a critical consideration for pediatric use.
Purpose of the Study:
- To compare the long-term effects of fluticasone propionate (FP) versus beclomethasone dipropionate (BDP) on growth in prepubertal children with asthma.
Main Methods:
- A prospective, multicenter, randomized, double-blind, parallel-group study.
- 277 children (aged 4-11 years) with asthma received either FP or BDP (200 mcg twice daily) via dry powder inhaler for 12 months.
- Growth velocity, lung function, and cortisol levels were assessed.
Main Results:
- Fluticasone propionate group exhibited significantly greater adjusted mean growth velocity (5.01 cm/y) compared to the beclomethasone dipropionate group (4.10 cm/y).
- Both ICS improved lung function, with FP showing a statistically significant advantage.
- No significant differences in adverse events or cortisol levels were observed between the groups.
Conclusions:
- Fluticasone propionate demonstrates a more favorable risk-benefit profile than beclomethasone dipropionate for long-term asthma treatment in children.
- FP is recommended over BDP for pediatric asthma, particularly when moderate doses are necessary.
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 microg 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.