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PEDIATRICS Vol. 113 No. 6 June 2004, pp. 1693-1699

Long-Term Effect of Budesonide on Hypothalamic-Pituitary-Adrenal Axis Function in Children With Mild to Moderate Asthma

Leonard B. Bacharier, MD*, Hengameh H. Raissy, PharmD{ddagger}, Laura Wilson, ScM§, Bennie McWilliams, MD{ddagger}, Robert C. Strunk, MD* and H. William Kelly, PharmD{ddagger}

* Division of Allergy and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine and St Louis Children’s Hospital, St Louis, Missouri
{ddagger} Department of Pediatrics, The University of New Mexico Health Science Center, Albuquerque, New Mexico
§ Johns Hopkins Bloomberg School of Hygiene and Public Health, Baltimore, Maryland

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 µg/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 µg/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.

Key Words: asthma • inhaled corticosteroids • hypothalamic-pituitary-adrenal axis • children • cortisol

Abbreviations: ICS, inhaled corticosteroid • HPA, hypothalamic-pituitary-adrenal • UFC, urinary free cortisol • Bud, budesonide • CAMP, Childhood Asthma Management Program • Ned, nedocromil • ACTH, adrenocorticotrophic hormone • BSA, body surface area

Received for publication Apr 7, 2003; Accepted Aug 14, 2003.


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eLetters:

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Physiological dose of ACTH
Brian J Lipworth
Pediatrics Online, 14 Jun 2004 [Full text]
Response to Dr. Lipworth's Comments
Leonard B Bacharier, et al.
Pediatrics Online, 15 Jun 2004 [Full text]