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New Data Presented at ACAAI Informs on the Safety and Efficacy of Nasacort AQ Nasal Spray in a Trial of Children Aged 2-5 Years Old with Year-Round Allergic Rhinitis
Date:11/10/2007

adrenal function from a subset of patients who participated in the same study described above. Adrenal function is responsible for many body processes such as response to stress, metabolism, the immune system, and sexual development and function.

Results reported by Dr. Nayak showed that 4 weeks of Nasacort AQ, given as 1 spray in each nostril once daily, did not significantly affect the average blood levels of the adrenal hormone "cortisol" compared with placebo among children 2-5 years with year-round allergic rhinitis.

"Traditionally there has been a concern regarding potential effects of the widely-used intranasal corticosteroids on adrenal function in children," said lead investigator Dr. Anjuli Nayak, University of Illinois College of Medicine. "We are encouraged by the results of this study which showed that during the 6 month study, Nasacort AQ did not cause significant adrenal suppression in children aged 2-5 years who suffer from year-round allergies."

Adrenal function was assessed in a subset of 61 children aged 2-5 years with PAR who received Nasacort AQ (n=33) or placebo (n=28) in the 4-week double-blind treatment phase; and in a subset of 49 children who continued on in a 6-month long open label extension period receiving Nasacort AQ once daily. To participate, patients had year-round allergic rhinitis for one year or longer and a positive skin prick test for allergens. Also, upon entering the study, patients needed normal morning cortisol levels. Cortisol measurements were conducted before and after adrenal stimulation with 1 mcg of cosyntropin hormone. A reduction in cortisol levels while receiving an intranasal corticosteroid treatment may signal adrenal suppression.

The patients' blood cortisol levels after cosyntropin are reported before and after the 4 weeks and 6 months of treatment. After four weeks, there was no significant reduction from baseline in the average level of morning cortisol in patients treated with Nasacor
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