AsthmaNet: UW-Madison Clinical and Translational Research Center

AsthmaNet：威斯康星大学麦迪逊分校临床和转化研究中心

• 批准号: 8099480
• 负责人: Robert F Lemanske
• 金额: $ 83.3万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 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/8099480
• 关键词: Address; Adult; Adult asthma; Affect; Age; Area; Asthma; Center for Translational Science Activities; Childhood; Childhood Asthma; Clinical Research; Clinical Trials; Collaborations; Development; Doctor of Pharmacy; Education; Environment; Fostering; Human Resources; Impairment; Inflammation; Inflammatory; Institutes; Leadership; Participant; Physiological; Policies; Population; Preschool Child; Principal Investigator; Procedures; Process; Protocols documentation; Recording of previous events; Recurrence; Regimen; Relative (related person); Research; Research Infrastructure; Risk; Role; Severities; Site; Sputum; Supplementation; Symptoms; Therapy Clinical Trials; Toddler; Translational Research; Viral Respiratory Tract Infection; Vitamin D; Wheezing; Wisconsin; asthma inhaler; atopy; experience; granulocyte; high risk; improved; member; multidisciplinary; novel; response

DESCRIPTION (provided by applicant): Asthma research addressing the mechanisms of severity of symptoms, asthma control, exacerbations, and response to therapy can be optimized with a multidisciplinary network. The Madison center has been a part of the Asthma Clinical Research Network (ACRN) and the Childhood Asthma Research and Education (CARE) Network since their inceptions in 1993 and 1999, respectively. Our center has extensive experience in clinical trials, skilled study personnel, and an integrated infrastructure that will allow us to conduct asthma protocols in both adult and pediatric participants.. In addition, the Madison center is experienced in performing several physiologic studies. The Madison center has an excellent history of subject recruitment and retention and has considerable experience in creating, and fostering a spirit of collaboration. We have access to adequate recruitment populations for pediatric, adult, and severe adult asthma subjects. UW received one of the CTSAs, permitting the establishment of the UW Institute for Clinical and Translational Research (ICTR), which collaborates with numerous member sites across Wisconsin. The application describes four novel protocols that address all of the clinical research areas deemed essential in the RFA. The first main trial, termed PITSA, is a therapeutic trial in adults with severe asthma to determine if asthma control can be improved using a combination regimen directed at reducing both eosinophilic and neutrophilic inflammation and will determine if the phenotypic profile of sputum inflammatory granulocytes predicts response to the treatment. The second main trial, termed LISA, answers an important question in preschool children by comparing the relative superiority of two asthma controllers on multiple risk and impairment domains of asthma control to address an important need in high-risk toddlers with recurrent wheezing and how atopy affects response to therapy. VIVA is a proof of concept and will evaluate the contribution of vitamin D levels to asthma control and the ability to modulate control through vitamin D supplementation. VISA is an overarching (age, severity, and environment) protocol that will prospectively evaluate an important determinant of asthma control and exacerbations: viral respiratory tract infections.

描述（由申请人提供）：解决症状严重程度、哮喘控制、恶化和治疗反应机制的哮喘研究可以通过多学科网络进行优化。自 1993 年和 1999 年成立以来，麦迪逊中心一直是哮喘临床研究网络 (ACRN) 和儿童哮喘研究和教育 (CARE) 网络的一部分。我们的中心在临床试验方面拥有丰富的经验、熟练的研究人员和综合基础设施，使我们能够对成人和儿童参与者进行哮喘方案。此外，麦迪逊中心在进行多项生理学研究方面经验丰富。麦迪逊中心在受试者招募和保留方面拥有悠久的历史，并且在创造和培养合作精神方面拥有丰富的经验。我们可以获得足够的儿童、成人和严重成人哮喘受试者的招募人群。威斯康辛大学获得了一项 CTSA，允许建立威斯康辛大学临床和转化研究所 (ICTR)，该研究所与威斯康星州的众多成员机构进行合作。该申请描述了四种新颖的方案，涉及 RFA 中认为重要的所有临床研究领域。第一个主要试验称为 PITSA，是一项针对患有严重哮喘的成人的治疗试验，以确定是否可以使用旨在减少嗜酸性粒细胞和中性粒细胞炎症的联合方案来改善哮喘控制，并将确定痰炎性粒细胞的表型特征是否可以预测反应到治疗。第二项主要试验名为 LISA，通过比较两种哮喘控制药物在哮喘控制的多个风险和损伤领域的相对优越性，回答了学龄前儿童的一个重要问题，以满足反复喘息的高风险幼儿的重要需求以及特应性如何影响对治疗的反应。 VIVA 是一个概念验证，将评估维生素 D 水平对哮喘控制的贡献以及通过补充维生素 D 调节控制的能力。 VISA 是一项总体（年龄、严重程度和环境）方案，它将前瞻性地评估哮喘控制和恶化的一个重要决定因素：病毒性呼吸道感染。