이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 9월 8일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

50

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Ontario
      • London, Ontario, 캐나다, N6A 4V2
        • St. Joseph's Health Care London
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Predictive Performance of Specialized Biomarkers for Asthma Remission and Relapse
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 12월 2일

기본 완료 (추정된)

2028년 12월 31일

연구 완료 (추정된)

2029년 3월 30일

연구 등록 날짜

최초 제출

2026년 9월 8일

QC 기준을 충족하는 최초 제출

2026년 9월 8일

처음 게시됨 (실제)

2026년 9월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 8일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다