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，国家犹太健康将在Richard Martin博士和Stanley Szefler博士的指导下，与来自ACRN和CARE网络的经验丰富的研究人员一起提供专业知识，并由Lisa Cicutto博士领导科罗拉多州临床和转化科学研究所的教育、培训和职业发展核心以及社区参与核心。为了了解成人哮喘、维生素D缺乏和肥胖的关系，我们将研究补充维生素D对增强吸入性皮质类固醇(ICS)反应的作用。在根据维生素D缺乏的证据和体重指数进行分层的ICS磨合期之后，年龄在18到70岁的哮喘患者将被随机分成ICS加维生素D或安慰剂，为期6个月，采用双盲、平行、安慰剂对照设计，以评估哮喘控制的变化。一项相关的机制研究将检验与MAP激酶-1途径相关的类固醇反应的细胞机制。为了改善幼儿哮喘的治疗，我们将评估三种治疗方法：通过雾化器/面罩提供的低剂量ICS，通过计量吸入器/间隔物/面罩提供的低剂量ICS，或口服白三烯拮抗剂。在安慰剂磨合后，1岁至5岁以下的哮喘儿童将按双盲平行设计随机接受一种治疗，为期一年。我们将测量症状控制和恶化情况，并根据患者的特征(包括生物标志物和遗传学)确定是否可以个体化治疗。为了评估一种新的治疗策略，我们将采用为期三个月的双盲、安慰剂对照、平行设计，研究omega3/抗氧化剂营养配方在12至18岁青少年运动性支气管痉挛中的作用。我们还将实施临床研究技能发展核心计划，并提供生理临床结果质量控制方面的专业知识，以培养哮喘的独立学术临床研究人员。国家犹太网站将为招募成人和儿童参加哮喘网络试验提供合作经验、领导技能和承诺。

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.