AsthmaNet: UW-Madison Clinical and Translational Research Center

描述（由申请人提供）：哮喘研究涉及症状严重程度、哮喘控制、恶化和治疗反应的机制，可以通过多学科网络进行优化。自1993年和1999年分别成立以来，麦迪逊中心一直是哮喘临床研究网络（ACRN）和儿童哮喘研究与教育（CARE）网络的一部分。我们的中心在临床试验方面有丰富的经验，有熟练的研究人员和综合的基础设施，使我们能够在成人和儿童参与者中实施哮喘方案。此外，麦迪逊中心在进行几项生理学研究方面经验丰富。麦迪逊中心在学科招募和保留方面有着出色的历史，在创造和培养合作精神方面有着丰富的经验。我们有足够的儿童、成人和严重成人哮喘患者的招募人群。华盛顿大学获得了其中一项CTSAs，允许建立华盛顿大学临床和转化研究所（ICTR），该研究所与威斯康星州的许多成员机构合作。该申请描述了四个新颖的方案，解决了RFA中所有被认为必不可少的临床研究领域。第一个主要试验称为PITSA，是一项针对严重哮喘成人的治疗性试验，旨在确定是否可以通过减少嗜酸性粒细胞和中性粒细胞炎症的联合方案改善哮喘控制，并将确定痰炎症粒细胞的表型谱是否预测对治疗的反应。第二个主要试验，称为LISA，通过比较两种哮喘控制者在哮喘控制的多个风险和损害领域的相对优势，回答了学龄前儿童的一个重要问题，以解决复发性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是一个概念证明，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，将前瞻性评估哮喘控制和恶化的重要决定因素：病毒性呼吸道感染。

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.