Sequential, Multiple Assignment, Randomized Trial in Severe Asthma Protocol (SMART-SA)
严重哮喘方案中的序贯、多重分配、随机试验 (SMART-SA)
基本信息
- 批准号:10454345
- 负责人:
- 金额:$ 32.89万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2017
- 资助国家:美国
- 起止时间:2017-09-23 至 2024-06-30
- 项目状态:已结题
- 来源:
- 关键词:AdoptedAdrenal Cortex HormonesAsthmaBiologicalBiological MarkersBloodBritish ColumbiaCaliforniaChronicClinicalClinical ResearchClinical TrialsDataData AnalysesDiseaseDoctor of MedicineDoxycyclineEnrollmentEosinophiliaFirmicutesGammaproteobacteriaGoalsGuidelinesHealthIL-6 inhibitorIL4 geneIL5 geneIL6 geneInfectionInflammationInstitute of Medicine (U.S.)Interleukin-1Interleukin-1 ReceptorsInterleukin-13InternationalInterventionKnowledgeLeadLungMucous body substanceNational Heart, Lung, and Blood InstituteObstructionOutcomePatient CarePatientsPersonsPhenotypePlasmaPrecision therapeuticsPredispositionProtocols documentationPulmonary Function Test/Forced Expiratory Volume 1ReportingResearchResearch InstituteSan FranciscoSequential Multiple Assignment Randomized TrialSiteSourceSpecific qualifier valueSputumSteroidsSubgroupSupervisionTestingTreatment FailureUniversitiesWithdrawalX-Ray Computed Tomographyadaptive interventionairway obstructionanakinraasthma exacerbationasthmaticasthmatic patientbasebiomarker performanceclinical centercohortcytokinedesigndisorder subtypedysbiosisefficacy testingeosinophilexperiencefollow-upgut microbiomeimprovedinhibitorinjured airwaymepolizumabmicrobialmolecular subtypesmucin hypersecretionnovelobese patientsolder patientpatient subsetspersonalized interventionprecision medicinepreventprimary outcomerecruitrespiratory microbiomeresponsetocilizumabtraittreatment guidelinestreatment responsetreatment trial
项目摘要
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.
总结/摘要
NHLBI针对重度和急性发作倾向哮喘的精确干预(Precise)网络将开展
适应性临床试验在严重和急性发作倾向的哮喘。在目标1中,我们建议建立一个国际
作为Precise临床中心的四个学术研究中心的联盟。该联盟将由大学领导
加州(UC)旧金山弗朗西斯科研究小组(联合会和研究中心PI:John Fahy)与三个
其他网站-加州大学戴维斯分校哮喘研究小组(网站PI:尼古拉斯凯尼恩),英国大学
哥伦比亚哮喘研究小组(研究中心PI:Mark FitzGerald)和莱斯特哮喘大学
研究小组(研究中心PI:Chris Billing)。所有这些都是在开展临床研究方面经验丰富的学术研究中心。
所有这些研究都对当前关于疾病的知识做出了重要贡献
哮喘的机制我们共同建议快速招募100名重度和急性发作患者,
易患哮喘的患者入组Precise,我们将实施
指导委员会。在目标2中,我们建议Precise应采用顺序多重分配
随机试验(SMART)方法,在哮喘患者亚组中进行适应性试验,
存在或不存在全身性IL 6炎症或全身性嗜酸性粒细胞增多。我们特别提出三个
临床试验,每项试验约占800人Precise队列的三分之一。试验1将按顺序测试
托珠单抗和阿那白滞素治疗IL-6高水平哮喘的疗效。试验#2将依次测试
美泊利单抗和Dupilumab逆转“2型高”哮喘患者的气流阻塞。试验#3将
序贯测试强力霉素和类固醇停药对“2型-
低”哮喘。在所有这些试验中,我们的首要目标是为患有更多疾病的患者推进精准医学。
严重的哮喘。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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John V Fahy其他文献
Development of an asthma health-care burden score as a measure of severity and predictor of remission in SARP III and U-BIOPRED: results from two major longitudinal asthma cohorts
开发哮喘保健负担评分作为 SARP III 和 U-BIOPRED 中严重程度的衡量指标和缓解预测因子:来自两个主要纵向哮喘队列的结果
- DOI:
10.1016/s2213-2600(24)00250-9 - 发表时间:
2025-01-01 - 期刊:
- 影响因子:32.800
- 作者:
Joe G Zein;Nazanin Zounemat-Kermani;Ian M Adcock;Bo Hu;Amy Attaway;Mario Castro;Sven-Erik Dahlén;Loren C Denlinger;Serpil C Erzurum;John V Fahy;Benjamin Gaston;Annette T Hastie;Elliot Israel;Nizar N Jarjour;Bruce D Levy;David T Mauger;Wendy Moore;Michael C Peters;Kaharu Sumino;Elizabeth Townsend;Eugene R Bleecker - 通讯作者:
Eugene R Bleecker
John V Fahy的其他文献
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{{ truncateString('John V Fahy', 18)}}的其他基金
Evaluating the Impact of Metabolic Dysfunction on Asthma Pathology and Physiology
评估代谢功能障碍对哮喘病理学和生理学的影响
- 批准号:
10688260 - 财政年份:2022
- 资助金额:
$ 32.89万 - 项目类别:
Evaluating the Impact of Metabolic Dysfunction on Asthma Pathology and Physiology
评估代谢功能障碍对哮喘病理学和生理学的影响
- 批准号:
10503780 - 财政年份:2022
- 资助金额:
$ 32.89万 - 项目类别:
Sequential, Multiple Assignment, Randomized Trial in Severe Asthma Protocol (SMART-SA)
严重哮喘方案中的序贯、多重分配、随机试验 (SMART-SA)
- 批准号:
10221035 - 财政年份:2017
- 资助金额:
$ 32.89万 - 项目类别:
Sequential, Multiple Assignment, Randomized Trial in Severe Asthma Protocol (SMART-SA)
严重哮喘方案中的序贯、多重分配、随机试验 (SMART-SA)
- 批准号:
9751962 - 财政年份:2017
- 资助金额:
$ 32.89万 - 项目类别:
A thiol-saccharide therapy to treat COVID-19
治疗 COVID-19 的硫醇糖疗法
- 批准号:
10226074 - 财政年份:2016
- 资助金额:
$ 32.89万 - 项目类别:
Carbohydrate-based Therapy for Lung Disease
以碳水化合物为基础的肺部疾病治疗
- 批准号:
10225939 - 财政年份:2016
- 资助金额:
$ 32.89万 - 项目类别:
Epithelial cell reprogramming and mucus gel pathology in self-sustaining type 2 airway niches in asthma
哮喘自我维持型 2 型气道微环境中的上皮细胞重编程和粘液凝胶病理学
- 批准号:
10226878 - 财政年份:2012
- 资助金额:
$ 32.89万 - 项目类别:
Exploring the biology of persistent type 2 airway niches in asthma
探索哮喘持续性 2 型气道生态位的生物学
- 批准号:
10472526 - 财政年份:2012
- 资助金额:
$ 32.89万 - 项目类别: