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Sustained Asthma Remission and Reduced RElapse Using a COmprehensive Management Strategy Randomized Control Trial (SARRE-COMS)

2026年9月8日 更新者:Hana Serajeddini
This study will evaluate whether specialized tests of airway inflammation and lung abnormalities can better predict asthma remission and relapse than standard clinical assessments in adults with severe asthma who are starting biologic therapy. Participants will be randomly assigned to receive either standard asthma care or a comprehensive management approach guided by specialized biomarker results. Participants will be followed for 12 months and will undergo assessments including questionnaires, lung function testing, blood collection, sputum analysis, CT imaging, and MRI imaging. The results of this study may help improve the prediction of asthma outcomes and support more personalized treatment strategies for patients with severe asthma.

研究概览

详细说明

Current clinical assessments and conventional biomarkers have limited ability to predict which patients will respond most favorably to treatment.

This pilot randomized controlled trial will evaluate whether specialized biomarkers of airway inflammation and lung abnormalities can better predict important asthma outcomes, including remission and relapse, than conventionally available biomarkers. The study will also assess whether a comprehensive management strategy guided by specialized biomarker assessments improves asthma outcomes compared with standard care.

Fifty adults with severe asthma who are initiating biologic therapy will be enrolled and randomized in a 1:1 ratio to either a standard of care group or a comprehensive management group. Participants assigned to the comprehensive management group will have treatment decisions informed by specialized biomarker results, while clinicians caring for participants in the standard of care group will remain blinded to these results.

Participants will be followed for 12 months and will undergo study assessments that include asthma questionnaires, pulmonary function testing, fractional exhaled nitric oxide (FeNO) testing, blood biomarker assessments, sputum cell analysis, computed tomography (CT) imaging, and magnetic resonance imaging (MRI). The study will compare asthma remission, relapse, airway inflammation, and structural airway abnormalities between groups.

The findings from this study will provide preliminary evidence regarding the utility of specialized biomarkers and biomarker-guided management strategies in severe asthma and may inform future larger clinical trials and personalized treatment approaches.

研究类型

介入性

注册 (估计的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Ontario
      • London、Ontario、加拿大、N6A 4V2
        • St. Joseph's Health Care London
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • • Patient understands study procedures and is will to participate in the study as indicated by the patient's signature.

    • Provision of written, informed consent prior to any study specific procedures.
    • Males and females ≥ 18 years of age.
    • Diagnosis of severe asthma, as defined by ATS/ERS guidelines (requiring high-dose ICS plus second controller and/or OCS, or uncontrolled despite this therapy).
    • Eligible for initiation of biologic therapy for treatment of asthma.
    • Women of childbearing potential (after menarche) must ensure that they are using an effective form of birth control for at least 2 months prior to each imaging visit. Examples of effective birth control include:
    • True sexual abstinence
    • A vasectomized sexual partner
    • Implanon®
    • Female sterilization by tubal occlusion
    • Effective intrauterine device (IUD)/levonogestrel intrauterine system (IUS)
    • Depo-Provera™ injections
    • Oral contraceptive
    • Evra Patch™
    • Nuvaring™
    • Women of childbearing potential (after menarche) must agree to use a highly effective form of birth control, as defined above, from enrollment, throughout the study duration, and X weeks after last dose of study drug, with negative urine pregnancy test result at Visit 1 and Visit 5.
    • Male participants who are sexually active must agree to use a double barrier method of contraception (male condom with diaphragm or male condom with cervical cap) from the first dose of the study drug until X weeks after last dose.

Exclusion Criteria:

  • • Primary respiratory diagnoses other than asthma (e.g., COPD, bronchiectasis).

    • Patients with incomplete medical records.
    • Patients who have received biologic treatment for asthma within the last 6 months.
    • Patient has an implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist).
    • In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI or CT, such as severe claustrophobia.
    • Patients with contraindications to PFT, sputum induction, CT or MRI imaging.
    • Patients who are pregnant or breastfeeding.
    • Patients who are unable or unwilling to comply with study procedures.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Comprehensive Management (Intervention)
Participants will receive asthma management according to routine clinical practice plus a comprehensive biomarker-guided management strategy. Specialized biomarker results will be made available to the treating clinician and may be used to guide treatment decisions.

Intervention Description

Participants will receive asthma management according to routine clinical practice in addition to a comprehensive biomarker-guided management strategy. Specialized biomarker assessments, including sputum cell analysis and imaging biomarkers, will be made available to the treating clinician and may be incorporated into clinical decision-making regarding asthma management. Treatment decisions may be informed by these specialized biomarker results throughout the 12-month study period.

有源比较器:Standard of Care
Participants will receive asthma management according to routine clinical practice. Specialized biomarker assessments will be performed, but the results will not be disclosed to the treating clinician and will not be used to guide treatment decisions.
Participants will receive asthma management according to routine clinical practice. Specialized biomarker assessments will be performed, but the results will not be disclosed to the treating clinician and will not be used to guide treatment decisions.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Predictive Performance of Specialized Biomarkers for Asthma Remission and Relapse
大体时间:Baseline to Month 12
To evaluate the association between baseline specialized clinical, physiologic, airway inflammatory, and imaging biomarkers and asthma outcomes, including sustained remission and relapse, over the 12-month follow-up period. The predictive performance of specialized biomarkers will be compared with that of conventionally available biomarkers.
Baseline to Month 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月2日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2029年3月30日

研究注册日期

首次提交

2026年9月8日

首先提交符合 QC 标准的

2026年9月8日

首次发布 (实际的)

2026年9月14日

研究记录更新

最后更新发布 (实际的)

2026年9月14日

上次提交的符合 QC 标准的更新

2026年9月8日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

The study team has not yet determined whether IPD will be shared with other researchers. Any future data-sharing plans will be developed in accordance with applicable ethics approvals, participant consent, and institutional policies.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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