UCSF AsthmaNet Clinical Center

加州大学旧金山分校哮喘网络临床中心

• 批准号: 8106287
• 负责人: Homer A Boushey
• 金额: $ 84.73万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 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/8106287
• 关键词: 10 year old; Accident and Emergency department; Accounting; Address; Adrenal Cortex Hormones; Adult; Affect; African American; Aftercare; Ally; Antibiotics; Asthma; Azithromycin; Biopsy; Breathing; Bronchitis; Caring; Charge; Child; Childhood; Childhood Asthma; Chronic Disease; Climate; Clinical; Clinical Trials Network; Conduct Clinical Trials; Defense Mechanisms; Development; Direct Costs; Disease; Dose; Double-Blind Method; Elderly; Ensure; Frequencies; Goals; Health; Hospitalization; Immune; Infection; Intake; Interleukin-13; Irrigation; Life; Lower Respiratory Tract Infection; Malabsorption Syndromes; Measures; Methods; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Nature; Nose; Obesity; Observational Study; Office Visits; Organism; Outcome; Parents; Patients; Pediatric Hospitals; Pharmaceutical Preparations; Pigments; Play; Population; Premature Birth; Prevalence; Pulmonary function tests; Randomized; Reporting; Resistance; Resources; Respiratory Tract Infections; Respiratory physiology; Rest; Risk; Risk Factors; Role; Sampling; Schools; Sea; Severities; Sinusitis; Skin; Source; Sputum; Sunlight; Supplementation; Surveys; Symptoms; Testing; The Sun; United States National Institutes of Health; Viral; Virus Diseases; Visit; Vitamin D; Vitamin D Deficiency; Wheezing; airway remodeling; asthmatic patient; base; bronchial epithelium; clinical practice; control trial; cost; design; health care service utilization; improved; middle age; novel; pathogen; prenatal; prevent; primary outcome; programs; protective behavior; receptor; respiratory; response; treatment as usual; treatment effect; young adult

DESCRIPTION (provided by applicant): This proposal is for the establishment of a UCSF/Children's Hospital Oakland Clinical Center in an NIHsupported network charged with conducting clinical trials of therapies for asthma in adults and children, including patients with severe asthma. As examples ofthe Clinical Trials this network could conduct, this application describes two studies. One trial derives from evidence on the importance of vitamin D for innate defense mechanisms in the bronchial epithelium. This trial would compare the effects of two doses of vitamin D on the frequency of asthma exacerbations in children: the current recommended dose of 400 IU/ day vs. the higher but well-tolerated dose of 2000 lU/day. The second trial examines the effects of treatment of asthma exacerbations with the antibiotic, azithromycin. Use of this antibiotic is common practice in treating asthma exacerbations, but rests on an extraordinarily slender body of evidence. Only one of (only) three previous studies showed any benefit, and that study examined a different antibiotic and showed small and inconsistent effects. Given the effects of widespread use of an antibiotic on the costs of care and on the emergence of resistant organisms, we believe the actual benefit of azithromycin treatment of asthma exacerbations needs to be determined. We also believe that such a study should examine a large enough population to allow examination of differential responses in sub-groups, such as those with symptoms of purulent bronchitis or sinusitis, those with positive culture or PCR for potential bacterial pathogens, and those with evidence of respiratory viral infection by PCR testing of sputum or nasal lavage samples. This proposal also describes two "Concept" studies of mechanisms of asthma that an NIH "AsthmaNet" network could undertake: one applying a highly novel, culture-independent method, the "PhyloChip" to examine differences in the bronchial microbiota in asthmatic patients regularly using - or naive to - inhaled corticosteroid treatment, how these bacterial populations are alTected by prolonged azithromycin treatment, and whether these effects are related to the effects of such treatment on markers of asthma control. The second "concept" study will examine the effects of an 1L-4/IL-13 receptor-antagonist on markers of airway remodeling by applying Designed-Based Stereology to bronchial biopsies obtained before and after treatment. The straightforward nature of these studies, the resources of UCSF/CHRCO, and the highly diverse nature of the populations they serve, will ensure generalizability to clinical practice of the findings made.

描述（由申请人提供）：该提案是用于建立UCSF/儿童医院奥克兰临床中心，该中心在NIHSPUPTRAPT的网络中，该网络负责进行成人和儿童哮喘疗法的临床试验，包括严重哮喘患者。作为该网络可以进行的临床试验的例子，该应用程序描述了两项研究。一项试验来自关于维生素D对支气管上皮的先天防御机制的重要性的证据。该试验将比较两种剂量维生素D对儿童哮喘恶化频率的影响：当前建议的剂量为400 IU/天，而较高但耐受良好的剂量为2000 lu/ day。第二次试验研究了用抗生素azithromycin治疗哮喘加重的影响。这种抗生素的使用是治疗哮喘恶化的常见实践，但基于一个非常细长的证据。 （只有）以前的三项研究中只有一项显示出任何好处，该研究检查了另一种抗生素，并显示出小且不一致的作用。鉴于广泛使用抗生素对护理成本和抗性生物的出现的影响，我们认为需要确定阿奇霉素治疗哮喘患病的实际好处。我们还认为，这样的研究应检查足够大的人群，以允许在亚组中检查差异反应，例如患有脓性支气管炎症状或鼻窦炎的症状，具有阳性培养或PCR的潜在细菌病原体的差异，以及通过PCR检测尖峰或鼻腔灌注样品的呼吸道病毒感染的证据。 This proposal also describes two "Concept" studies of mechanisms of asthma that an NIH "AsthmaNet" network could undertake: one applying a highly novel, culture-independent method, the "PhyloChip" to examine differences in the bronchial microbiota in asthmatic patients regularly using - or naive to - inhaled corticosteroid treatment, how these bacterial populations are alTected by prolonged azithromycin治疗以及这些影响是否与这种治疗对哮喘控制标志物的影响有关。第二项“概念”研究将检查1L-4/IL-13受体抗抗酸剂对气道重塑标记的影响，通过将设计的基于设计的立体学应用于治疗前和治疗后获得的支气管活检。这些研究的直接性质，UCSF/CHCO的资源以及他们所服务的人群的高度多样性，将确保对发现结果的临床实践的普遍性。