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Systemic activity of inhaled steroids in 1- to 3-year-old children with asthma
Jacob Anhøj1, Anne Marie Bisgaard, Hans Bisgaard
1Pulmonary Service, Department of Paediatrics, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Insights
Inhaled corticosteroids fluticasone propionate (FP) and budesonide (BUD) show systemic activity in young children with asthma. Both FP and BUD reduced leg growth, indicating potential side effects in preschool children.
Area of Science:
- Pediatric Pulmonology
- Pharmacology
- Endocrinology
Background:
- Inhaled corticosteroids (ICS) are a common treatment for pediatric asthma.
- Assessing the systemic activity of ICS in young children is crucial for understanding potential growth impacts.
Purpose of the Study:
- To evaluate the systemic activity of inhaled fluticasone propionate (FP) and budesonide (BUD) in children aged 1 to 3 years.
- To compare the effects of FP and BUD on growth velocity.
Main Methods:
- A randomized, double-blind, placebo-controlled crossover trial involving 40 children with mild asthma.
- Systemic steroid activity was assessed using knemometry to measure lower-leg length growth over 4 weeks.
- Treatments included FP (400 mcg/day), BUD (400 mcg/day), and placebo, delivered via metered-dose inhalers and spacers.
Main Results:
- Both FP and BUD significantly reduced lower-leg growth velocity compared to placebo.
- FP reduced growth by 51 microm/day and BUD by 40 microm/day, with no significant difference between the two steroids.
- The study analyzed the intention-to-treat population using analysis of variance.
Conclusions:
- Inhaled fluticasone propionate and budesonide are systemically active in young children (1-3 years) at a daily dose of 400 mcg.
- These findings highlight the need for further studies on the clinical side effects of these inhaled steroid regimens in preschool children.
Objective:
To study the systemic activity of inhaled steroids in young children.
Methods:
Forty children with mild asthma aged 1 to 3 years were studied in a 3-way crossover, randomized, placebo-controlled, double-blind trial. Treatment with inhaled fluticasone propionate, 200 microg twice daily delivered via pressurized metered-dose inhaler (pMDI) and Babyhaler (FP400), was compared with budesonide, 200 microg twice daily delivered via pMDI and NebuChamber (BUD400), and to placebo. The Babyhaler was primed before use. Knemometry was used to detect systemic steroid activity. It was performed with a hand-held knemometer after 1 and 4 weeks of treatment. The increase in lower-leg length within this 3-week period was used as the outcome measure. The intention-to-treat population was analyzed by analysis of variance.
Results:
The increases in the lower-leg length during placebo, BUD400, and FP400 treatments were 85, 45, and 34 microm/d, respectively (adjusted mean). The growth in lower-leg length was significantly reduced from both steroid treatments. The difference between BUD400 and placebo was -40 microm/d (n = 25; 95% confidence interval [CI]: -8 to -72). The difference between FP400 and placebo was -51 microm/d (n = 26; 95% CI: -19 to -83). The difference between FP and BUD was -11 microm/d and was not statistically significant (n = 28; 95% CI: 20 to -42).
Conclusion:
FP and BUD are both systemically active in children 1 to 3 years old when administered for 4 weeks from their dedicated spacer devices in daily doses of 400 microg with no difference between the 2 steroid regimens. These findings call for studies of clinical side effects from these treatments of preschool children.
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