严重哮喘方案中的序贯、多重分配、随机试验 (SMART-SA)-猫眼课题宝

严重哮喘方案中的序贯、多重分配、随机试验 (SMART-SA)

批准号：

9751962

负责人：

John V Fahy

金额：

$38.4万

依托单位：

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

依托单位国家：

美国

项目类别：

财政年份：

2017

资助国家：

美国

项目状态：

已结题

起止时间：

2017-09-23 至 2023-06-30

来源：

https://reporter.nih.gov/project-details/9751962

关键词：

Adopted Adrenal Cortex Hormones Asthma Biological Biological Markers Blood British Columbia California Chronic Clinical Clinical Research Clinical Trials Data Data Analyses Disease Doctor of Medicine Doxycycline Enrollment Eosinophilia Firmicutes Gammaproteobacteria Goals Guidelines Health IL4 gene IL5 gene IL6 gene Infection Inflammation Institute of Medicine (U.S.)Interleukin-1 Interleukin-1 Receptors Interleukin-13 International Intervention Knowledge Lead Lung Mucous body substance National Heart, Lung, and Blood Institute Obesity Obstruction Outcome Patient Care Patients Persons Phenotype Plasma Precision therapeutics Predisposition Protocols documentation Pulmonary Function Test/Forced Expiratory Volume 1 Reporting Research Research Institute San Francisco Site Source Specific qualifier value Sputum Steroids Subgroup Supervision Testing Treatment Failure Universities Withdrawal X-Ray Computed Tomography adaptive intervention airway obstruction anakinra asthma exacerbation asthmatic asthmatic patient base biomarker performance cohort cytokine design disorder subtype dysbiosis efficacy testing eosinophil experience follow-up gut microbiome improved inhibitor/antagonist injured airway mepolizumab microbial molecular subtypes mucin hypersecretion novel patient subsets personalized intervention precision medicine prevent primary outcome randomized trial recruit respiratory microbiome response trait treatment guidelines treatment response treatment trial

中文摘要

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英文摘要

Summary/Abstract The NHLBI Precision Interventions for Severe and Exacerbation Prone Asthma (PrecISE) Network will conduct adaptive clinical trials in severe and exacerbation prone asthma. In Aim 1 we propose to form an international consortium of four academic sites as a clinical center for PrecISE. The consortium will be led by the University of California (UC) San Francisco asthma group (consortium and site PI: John Fahy) in partnership with three other sites - the UC Davis Asthma Research Group (site PI: Nicholas Kenyon), the University of British Columbia Asthma Research Group (site PI: Mark FitzGerald), and the University of Leicester Asthma Research Group (site PI: Chris Brightling). All are academic sites highly experienced in conducting clinical studies in severe asthma, and all have made important contributions to current knowledge about disease mechanisms in asthma. Together, we propose to quickly recruit 100 patients with severe and exacerbation prone asthma for enrollment in PrecISE, and we will implement each network-wide protocol approved by the Steering Committee. In Aim 2 we propose that PrecISE should adopt the sequential multiple assignment randomized trial (SMART) approach to conduct adaptive trials in subgroups of asthmatics defined by the presence or absence of systemic IL6 inflammation or systemic eosinophilia. We specifically propose three clinical trials, each in approximately one third of the 800 person PrecISE cohort. Trial #1 will sequentially test the efficacy of Tocilizumab and Anakinra in IL6-high asthma. Trial #2 will sequentially test the efficacy of Mepolizumab and Dupilumab in reversing airflow obstruction in patients with “type 2-high” asthma. Trial #3 will sequentially test the efficacy of Doxycycline and steroid withdrawal on asthma control in patients with “type 2- low” asthma. In all of these trials, our overarching goal is to advance precision medicine for patients with more severe forms of asthma.

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