EFFECT OF NASALLY ADMINISTERD BUDESONIDE RESPULES ON ADRENAL FUNCTION

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。鼻鼻窦炎的患病率和发病率正在增加，据估计，美国每年约有3100万患者受到影响。它会导致严重的身体症状，对生活质量产生负面影响，并可能严重损害日常功能。 鼻用类固醇是主要的治疗方法，尽管并非所有慢性鼻窦炎患者都能通过鼻用类固醇得到改善。普米克令舒由无菌混悬液组成，可通过喷射雾化器吸入，含有活性成分布地奈德。据信，雾化递送系统比标准鼻用类固醇制剂产生更好的治疗反应。根据PDR中包含的信息，通过喷射雾化器肺部给予普米克令舒后，哮喘儿童的总绝对生物利用度（即肺部+口服）约为标示剂量的6%。布地奈德的血浆峰浓度出现在雾化开始后10-30分钟。布地奈德鼻腔给药后的吸收量是已知的。 本研究的目的是评估普米克令舒鼻腔给药30天是否会因全身吸收而导致肾上腺功能抑制。将在12个月期间招募20名患有慢性鼻窦炎（伴或不伴鼻息肉）的成人患者。在促肾上腺皮质激素给药前和给药后30分钟测定患者的皮质醇水平（即，促肾上腺素试验）。研究期间将进行两次促肾上腺素试验。第一次将在普米克令舒开始时进行，第二次将在普米克令舒每日给药后30天进行。主要结果测量将是30天普米克令舒治疗后刺激的皮质醇绝对数量。这将被计算为促肾上腺皮质激素注射前的皮质醇数量与促肾上腺皮质激素注射后的数量之间的差异。次要结果测量将包括基线和促肾上腺皮质激素给药前30天的皮质醇值。

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.