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Growth in asthmatic children treated with fluticasone propionate. Fluticasone Propionate Asthma Study Group
D B Allen1, E A Bronsky, C F LaForce
1University of Wisconsin Children's Hospital, Madison 53792-4108, USA.
Insights
Inhaled fluticasone propionate did not affect growth in children with persistent asthma. Studies show similar growth rates compared to placebo over one year in prepubescent children.
Area of Science:
- Pediatric pulmonology
- Pharmacological effects on growth
- Asthma management
Background:
- Persistent asthma affects children's quality of life.
- Inhaled corticosteroids are a common asthma treatment.
- Concerns exist regarding potential growth suppression in children.
Purpose of the Study:
- To evaluate the long-term impact of inhaled fluticasone propionate on growth in children with persistent asthma.
- To compare growth rates in children treated with different doses of fluticasone propionate versus placebo.
Main Methods:
- A double-blind, randomized, placebo-controlled trial involving 325 prepubescent children.
- Children received either placebo or inhaled fluticasone propionate (50 or 100 microg twice daily) for one year.
- Monthly growth assessments and periodic pulmonary function tests were conducted.
Main Results:
- No statistically significant differences in mean height, growth velocity, or skeletal age were observed between treatment groups.
- Mean height increase over one year was comparable across placebo, 50 microg, and 100 microg fluticasone propionate groups.
- The overall p-value for height increase was 0.308, indicating no significant treatment effect.
Conclusions:
- Inhaled fluticasone propionate at 50 and 100 microg twice daily for one year did not adversely affect growth in prepubescent children with persistent asthma.
- Growth rates were similar to those of placebo-treated children and consistent with expected velocity for age.
- These findings support the safety of inhaled fluticasone propionate for growth in pediatric asthma patients.
Objective:
To determine whether inhaled fluticasone propionate has long-term effects on growth in children with persistent asthma.
Study Design:
In a double-blind, randomized, parallel-group, multicenter study, 325 prepubescent children with persistent asthma and normal growth rates were treated with placebo or inhaled fluticasone propionate powder 50 microg or 100 microg administered twice daily by a breath-actuated device for 1 year. Growth was evaluated monthly, whereas other safety variables and pulmonary function were evaluated periodically.
Results:
The prepubescent patients showed no statistically significant differences in mean height, mean growth velocity, or mean skeletal age between any of the treatment groups at any time. Over a period of 1 year, mean height (+/- SE) increased 6.15 +/- 0.17 cm in the placebo group, 5.94 +/- 0.16 cm in the fluticasone propionate 50 microg group, and 5.73 +/- 0.13 cm in the fluticasone propionate 100 microg group (p = 0.308, overall).
Conclusions:
Prepubescent children treated with fluticasone propionate 50 microg and 100 microg administered twice daily for 1 year grew at rates similar to placebo-treated control subjects and at rates equal to expected growth velocity for age.
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