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Long-term effect of budesonide on hypothalamic-pituitary-adrenal axis function in children with mild to moderate
Leonard B Bacharier1, Hengameh H Raissy, Laura Wilson
1Division of Allergy and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine and St Louis Children's Hospital, St Louis, Missouri 63110, USA. bacharier_l@kids.wustl.edu
Insights
Long-term budesonide for pediatric asthma showed no negative impact on the hypothalamic-pituitary-adrenal (HPA) axis. This 3-year study confirms budesonide safety in children with mild to moderate asthma.
Area of Science:
- Pediatric Endocrinology
- Respiratory Medicine
- Pharmacology
Background:
- Inhaled corticosteroids (ICS) are standard therapy for persistent asthma in children.
- Concerns exist regarding the long-term safety of ICS, particularly effects on the hypothalamic-pituitary-adrenal (HPA) axis.
- Budesonide is a commonly prescribed ICS for pediatric asthma management.
Purpose of the Study:
- To evaluate the safety of 36-month budesonide administration on HPA axis function in children with mild to moderate asthma.
- To assess the cumulative effects of budesonide on HPA axis function over a three-year period.
Main Methods:
- Ancillary study of the Childhood Asthma Management Program (CAMP) involving 63 children.
- HPA axis function assessed via serum cortisol response to adrenocorticotrophic hormone (ACTH) stimulation and 24-hour urinary free cortisol excretion at baseline, 12, and 36 months.
- Children received continuous therapy with budesonide (400 microg/day), nedocromil (16 mg/day), or placebo.
Main Results:
- No significant differences in serum cortisol levels post-ACTH stimulation were observed between treatment groups at any time point.
- Urinary free cortisol excretion remained similar across groups at 36 months, after adjusting for relevant covariates.
- Cumulative exposure to inhaled budesonide did not correlate with altered HPA axis function.
Conclusions:
- Chronic budesonide treatment at 400 microg/day is safe for HPA axis function in children with mild to moderate asthma.
- No cumulative adverse effects on HPA axis function were detected over a three-year treatment period.
- These findings support the long-term safety profile of budesonide in pediatric asthma management.
Objective:
To determine the safety of long-term (36 months) administration of an inhaled corticosteroid (budesonide) on hypothalamic-pituitary-adrenal (HPA) axis function in children with mild to moderate asthma.
Methods:
This was an ancillary study of the Childhood Asthma Management Program (CAMP). Sixty-three children who had mild to moderate asthma and were enrolled in CAMP underwent evaluation of HPA axis function before and 12 and 36 months after receiving continuous therapy with either an inhaled anti-inflammatory agent (budesonide 400 microg/day or nedocromil 16 mg/day) or placebo. HPA axis function was assessed by serum cortisol levels 30 and 60 minutes after 0.25 mg of adrenocorticotrophic hormone (ACTH) and 24-hour urinary free cortisol excretion.
Results:
There were no differences in serum cortisol levels after ACTH stimulation between treatment groups, regardless of time after ACTH administration or months of follow-up. Urinary cortisol excretion per body surface area was similar in both treatment groups at 36 months, after adjusting for age at randomization, race, gender, and clinic. Cumulative inhaled corticosteroid exposure did not influence serum cortisol response to ACTH or urinary free cortisol excretion at 36 months.
Conclusions:
We found no effects of chronic budesonide treatment at a dose of 400 micro g/day on HPA axis function in children with mild to moderate asthma and demonstrated the absence of a cumulative effect on HPA axis function over a 3-year period.
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