EFFECT OF NASALLY ADMINISTERD BUDESONIDE RESPULES ON ADRENAL FUNCTION

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。鼻窦炎的患病率和发病率都在增加，据估计，美国每年约有3100万患者受到鼻窦炎的影响。它会引起严重的身体症状，对生活质量产生负面影响，并可能严重损害日常功能。鼻腔类固醇是治疗的主要方法，但并非所有慢性鼻窦炎患者使用鼻腔类固醇均能改善。Pulmicort Respules由无菌悬浮液组成，可通过喷射雾化器吸入，并含有有效成分布地奈德。据信，雾化递送系统比标准鼻腔类固醇制剂具有更好的治疗反应。根据PDR中包含的信息，哮喘儿童在通过喷射雾化器给药后的总绝对生物利用度（即肺+口服）约为标记剂量的6%。布地奈德的血药浓度峰值出现在开始雾化后10-30分钟。布地奈德经鼻应用后吸收量是已知的。本研究的目的是评估经鼻给药普米克30天是否会由于全身吸收而抑制肾上腺功能。20名患有慢性鼻窦炎的成年患者，伴或不伴鼻息肉，将在12个月的时间内入选。患者将在服用共syntropin（即cosyntropin）前和30分钟后测定皮质醇水平。（共syntropin试验）。在研究期间，将进行两次促性腺激素测试。第一次是在服药后，第二次是在服药后30天。主要观察指标是普米克治疗30天后刺激的绝对皮质醇数。这将被计算为注射共syntropin前和注射共syntropin后皮质醇数的差值。次要结局指标包括给药前的基线和30天皮质醇值。

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.