Clinical Centers for the NHLBI Asthma Network (AsthmaNet)

NHLBI 哮喘网络 (AsthmaNet) 临床中心

• 批准号: 8691988
• 负责人: Stanley J Szefler
• 金额: $ 69.18万
• 依托单位: NATIONAL JEWISH HEALTH
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8691988
• 关键词: Address; Adolescent; Adrenal Cortex Hormones; Adult; Age; Antioxidants; Asthma; Body mass index; Breathing; Characteristics; Child; Clinical; Clinical Investigator; Clinical Research; Clinical Sciences; Clinical Trials; Colorado; Communities; Development; Dose; Double-Blind Method; Exercise-Induced Bronchospasm; Genetic Markers; Health; Institutes; Leadership; Leukotriene Antagonists; Measures; Metered Dose Inhaler Device; Mitogen Activated Protein Kinase 1; National Heart, Lung, and Blood Institute; Nebulizer; Nutritional; Obesity; Oral; Outcome; Pathway interactions; Patients; Physiological; Placebo Control; Placebos; Quality Control; Randomized; Research Personnel; Role; Running; Site; Steroids; Supplementation; Symptoms; Training and Education; Translational Research; Vitamin D; Vitamin D Deficiency; base; career development; design; experience; face mask; follower of religion Jewish; improved; innovation; novel; response; skills; treatment duration; treatment strategy

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.

描述（由申请人提供）：为了解决通过哮喘的新治疗方法，国家犹太人健康将在DRS的指导下贡献专业知识。理查德·马丁（Richard Martin）和斯坦利·斯泽夫勒（Stanley Szefler）以及来自ACRN和Care Networks的经验丰富的调查员，以及Lisa Cicutto博士作为教育，培训和职业发展核心的领导者以及科罗拉多州临床和转化科学研究所的社区参与核心。为了了解哮喘，维生素D缺乏症和成人肥胖的关系，我们将研究补充维生素D在增强吸入皮质类固醇（ICS）反应的作用。经过一定的ICS，基于维生素D缺乏症的证据并分层为体重指数，患有哮喘的受试者，年龄在18至70岁之间，将在6个月内随机分配给ICS加上维生素D或安慰剂，在双盲，平行的，安慰剂的控制型设计中，以评估Asthma Control的变化。一项相关的机械研究将检查与MAP激酶-1途径相关的类固醇反应的细胞机制。为了改善幼儿的哮喘治疗，我们将评估三种治疗方法：通过雾化器/面罩提供的低剂量IC，通过计量剂量吸入器/间隔者/面罩的低剂量IC，或口服白细胞拮抗剂。安慰剂失败后，患有哮喘的儿童1至不到5岁，将在一年的研究期间以双盲平行设计中随机分配给一种治疗。我们将根据患者特征在内的患者特征（包括生物标志物和遗传学）来衡量症状控制和加剧，并确定是否可以个性化治疗。为了评估一种新的治疗策略，我们将使用双盲，安慰剂控制的，平行的，平行的，在三个月的治疗期间，研究omega3/抗氧化剂营养公式对运动诱导的支气管痉挛的作用。我们还将实施临床研究技能发展核心计划，并在生理临床成果的质量控制方面贡献专业知识，以发展哮喘的独立学术临床研究者。国家犹太人网站将贡献合作经验，领导能力和承诺，以招募成人和儿童参加哮喘试验。