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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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

50

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Ontario
      • London、Ontario、カナダ、N6A 4V2
        • St. Joseph's Health Care London
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Predictive Performance of Specialized Biomarkers for Asthma Remission and Relapse
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

協力者

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年12月2日

一次修了 (推定)

2028年12月31日

研究の完了 (推定)

2029年3月30日

試験登録日

最初に提出

2026年9月8日

QC基準を満たした最初の提出物

2026年9月8日

最初の投稿 (実際)

2026年9月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月14日

QC基準を満たした最後の更新が送信されました

2026年9月8日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • SJHC 005

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

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.

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米国FDA規制機器製品の研究

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