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）：为了通过AsthmaNet解决新的治疗方法，国家犹太健康中心将在博士的指导下提供专业知识。Richard Martin和Stanley Szefler以及来自ACRN和CARE网络的经验丰富的研究人员，以及Lisa Cicutto博士作为科罗拉多临床和转化科学研究所教育，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缺乏和肥胖之间的关系，我们将研究补充维生素D对增强吸入皮质类固醇（ICS）反应的作用。根据维生素D缺乏的证据和体重指数分层，经过一段ICS适应期后，18至70岁的哮喘患者将随机分为ICS加维生素D或安慰剂组，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。为了改善幼儿哮喘管理，我们将评估三种治疗方法：通过雾化器/面罩给药的低剂量ICS，通过计量吸入器/间隔器/面罩给药的低剂量ICS，或口服白三烯拮抗剂。在安慰剂试验后，1岁至5岁以下的哮喘儿童将在双盲平行设计中随机接受一种治疗，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）进行个体化治疗。为了评估一种新的治疗策略，我们将采用双盲、安慰剂对照、平行设计，在三个月的治疗期内，研究omega - 3/抗氧化营养配方在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，并在生理临床结果的质量控制方面提供专业知识，以培养哮喘领域独立的学术临床研究者。国家犹太网站将为招募成人和儿童参与AsthmaNet试验贡献合作经验、领导技能和承诺。