Clinical Centers for the NHLBI Asthma Network (AsthmaNet)

描述（由申请人提供）：为了通过AsthmaNet解决新的治疗方法，National Jewish Health将在Richard Martin博士和Stanley Szefler沿着以及来自ACRN和CARE网络的经验丰富的研究人员的指导下提供专业知识，丽莎Cicutto博士将担任科罗拉多临床和转化科学研究所的教育，培训和职业发展核心和社区参与核心的领导者。为了了解成人哮喘、维生素D缺乏和肥胖的关系，我们将研究维生素D补充剂对增强吸入性皮质类固醇（ICS）反应的作用。ICS导入期后，根据维生素D缺乏的证据并按体重指数分层，年龄18 - 70岁的哮喘受试者将随机接受ICS+维生素D或安慰剂治疗6个月，采用双盲、平行、安慰剂对照设计，以评价哮喘控制的变化。相关的机制研究将检查与MAP激酶-1通路相关的类固醇反应的细胞机制。为了改善幼儿哮喘的管理，我们将评估三种治疗方法：通过雾化器/面罩给予低剂量ICS，通过定量吸入器/喷雾器/面罩给予低剂量ICS，或口服白三烯拮抗剂。在安慰剂导入期后，1至5岁以下的哮喘儿童将在为期一年的研究期内以双盲、平行设计随机接受一种治疗。我们将测量症状控制和加重，并确定是否可以根据患者特征（包括生物标志物和遗传学）进行个性化治疗。为了评估一种新的治疗策略，我们将在三个月的治疗期内，采用双盲、安慰剂对照、平行设计，研究omega 3/抗氧化剂营养配方对12至18岁青少年运动诱发支气管痉挛的作用。我们还将实施临床研究技能发展核心计划，并在生理临床结果的质量控制方面提供专业知识，以培养独立的哮喘学术临床研究人员。国家犹太网站将贡献协作经验，领导技能和承诺招募成人和儿童参加哮喘试验。

DESCRIPTION (provided by applicant): To address new treatment approaches through AsthmaNet, National Jewish Health will contribute expertise under the direction of Drs. Richard Martin and Stanley Szefler along with experienced investigators from the ACRN and CARE Networks, and Dr. Lisa Cicutto as leader in the Education, Training and Career Development Core and the Community Engagement Core of the Colorado Clinical and Translational Sciences Institute. To understand the relationship of asthma, vitamin D deficiency and obesity in adults, we will examine the role of vitamin D supplementation to enhance inhaled corticosteroid (ICS) response. After a run-in period of ICS, based on evidence of vitamin D deficiency and stratified for body mass index, subjects with asthma, ages 18 to 70 years, will be randomized to ICS plus vitamin D or placebo for a 6-month period in a double-blind, parallel, placebo controlled design to evaluate change in asthma control. An associated mechanistic study will examine cellular mechanisms of steroid response related to the MAP kinase-1 pathway. To improve asthma management in young children, we will evaluate three treatments: low dose ICS delivered via nebulizer/face mask, low dose ICS via metered dose inhaler/spacer/face mask, or an oral leukotriene antagonist. After a placebo run-in, children with asthma, ages 1 to less than 5 years, will be randomized to one treatment in a double-blind, parallel design for a one-year study period. We will measure symptom control and exacerbations and also determine whether therapy can be individualized based on patient characteristics including biomarkers and genetics. To evaluate a novel treatment strategy, we will examine the role of an omega3/antioxidant nutritional formula on exercise-induced bronchospasm in adolescents, ages 12 to 18 years, using a double-blind, placebo controlled, parallel design over a three month treatment period. We will also implement a Clinical Research Skills Development Core Plan and contribute expertise in quality control of physiological clinical outcomes to develop independent academic clinical investigators in asthma. The National Jewish site will contribute collaborative experience, leadership skills and commitment for recruitment of adults and children to participate in AsthmaNet trials.