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Effect of budesonide aqueous nasal spray on hypothalamic-pituitary-adrenal axis function in children with allergic
Kenneth T Kim1, Nathan Rabinovitch, Thomas Uryniak
1Allergy, Asthma & Respiratory Care Medical Center, Long Beach, California 90806, USA. drkkim@wcctrials.com
Insights
Budesonide aqueous nasal spray is safe for young children with allergic rhinitis. This study found no significant impact on hypothalamic-pituitary-adrenal (HPA) axis function in children aged 2-5 years.
Area of Science:
- Pediatric Allergy and Immunology
- Endocrinology
- Pharmacology
Background:
- Intranasal corticosteroids are standard for adult allergic rhinitis.
- Pediatric systemic corticosteroid exposure raises safety concerns.
- Evaluating HPA axis function is crucial for pediatric corticosteroid safety.
Purpose of the Study:
- To assess the impact of budesonide aqueous nasal spray on HPA axis function in young children with allergic rhinitis.
- To determine safety and tolerability of budesonide in pediatric patients.
- To evaluate effects at the recommended once-daily dose.
Main Methods:
- A 6-week, multicenter, double-blind, placebo-controlled study.
- 78 children aged 2-5 years with allergic rhinitis participated.
- HPA axis function assessed via plasma cortisol levels post-cosyntropin stimulation.
Main Results:
- No significant differences in plasma cortisol levels between budesonide and placebo groups.
- HPA axis function remained unaffected in the budesonide treatment group.
- Safety and tolerability profiles were comparable to placebo.
Conclusions:
- Budesonide aqueous nasal spray is safe and well-tolerated in children aged 2-5 years.
- No measurable suppressive effects on HPA axis function were observed.
- Supports the use of budesonide for pediatric allergic rhinitis.
Background:
Intranasal corticosteroids are safe and effective for treating allergic rhinitis in adults. Since children may receive more systemic corticosteroid on a dose-per-weight basis than adults, the safety of corticosteroid therapy in pediatric patients is an important issue.
Objective:
To determine the effects of treatment with budesonide aqueous nasal spray using the recommended once-daily dose for adults and children 6 years and older on hypothalamic-pituitary-adrenal (HPA) axis function in pediatric patients with allergic rhinitis.
Methods:
In a 6-week, multicenter, double-blind, placebo-controlled study, 78 patients aged 2 to 5 years with allergic rhinitis were treated with budesonide aqueous nasal spray (64 microg/d) or placebo. Mean change in morning plasma cortisol levels from baseline to study end 0, 30, and 60 minutes after low-dose (10-microg) cosyntropin stimulation and mean change in the difference from 0 to 30 minutes and from 0 to 60 minutes after cosyntropin stimulation were used to evaluate HPA axis function.
Results:
Mean change from baseline to study end in plasma cortisol levels 0, 30, and 60 minutes after cosyntropin stimulation and the difference from 0 to 30 minutes and from 0 to 60 minutes were not significantly different between the treatment and placebo groups (P > .05 for all). At the end of the study, 3 budesonide aqueous nasal spray and 6 placebo patients were classified as having subnormal HPA axis function. The safety and tolerability profile of budesonide aqueous nasal spray was comparable to that of placebo.
Conclusions:
Administration of budesonide aqueous nasal spray for 6 weeks was well tolerated and safe and had no measurable suppressive effects on HPA axis function in patients aged 2 to 5 years with allergic rhinitis.
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