EFFECT OF NASALLY ADMINISTERD BUDESONIDE RESPULES ON ADRENAL FUNCTION

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Rhinosinusistis is increasing in prevalence and incidence, and has been estimated to affect approximately 31 million patients in the United States each year. It causes significant physical symptoms, negatively affects quality of life, and can be substantially impair daily functioning. Nasal steroids are the mainstay of treatment, although not all patients with chronic rhinosinusitis improve with nasal steroids. Pulmicort Respules consist of a sterile suspension for inhalation via jet nebulizer and contain the active ingredient budesonide. It is believed that the nebulized delivery system leads to better treatment response than standard nasal steroid preparations. According to information contained in the PDR, total absolute bioavailability (ie, lung + oral) in asthmatic children following pulmonary administration of Pulmicort Respules via jet nebulizer was approximately 6% of the labeled dose. The peak plasma concentration of budesonide occurred 10-30 minutes after start of nebulization. The amount of budesonide absorbed following nasal application is known. The goal of this study is to assess whether nasal administration of Pulmicort Respules for 30 days results in suppression of adrenal function as a result of systemic absorption. Twenty adult patients with chronic rhinosinusitis, with or without nasal polyps, will be enrolled over a 12-month period. Patients will have cortisol levels determined before and 30 minutes after administration of cosyntropin (ie., cosyntropin test). The cosytropin test will be performed twice during the study. The first time will be at the initiation of Pulmicort respules and the second time will be 30 days aftewr Pulmicort respules on a daily basis. The primary outcome measure will be the absolute cortisol number stimulated after 30 days of Pulmicort respule therapy. This will be calculated as the difference between the cortisol number before cosyntropin injection and the number after cosyntropin injection. Secondary outcome measures will include baseline and 30-day cortisol value before cosyntropin administration.