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T2AIR: Real-World Efficacy and Safety of Biologics Targeting Type 2 Inflammation in Asthma and COPD (T2AIR)

2026年9月13日 更新者：Gao Yong-hua、Shanghai Pulmonary Hospital, Shanghai, China

Real-World Efficacy and Safety of Biologics Targeting Type 2 Inflammation Across the Spectrum of Chronic Airway Diseases - A Prospective Observational Study in Asthma and COPD

This prospective, real-world observational study (T2AIR Study) evaluates the long-term efficacy and safety of six biologics targeting Type 2 inflammation - omalizumab, mepolizumab, benralizumab, dupilumab, tezepelumab, and depemokimab - in patients with chronic airway diseases, including asthma and COPD under routine clinical practice in China.

The primary objective is to determine the annualized exacerbation rate (AER) over 12 months of treatment. Secondary objectives include time to first exacerbation, frequency of severe exacerbations, improvements in symptom control and quality of life (using disease-specific questionnaires), lung function (FEV₁, FVC), airway inflammatory biomarkers (FeNO, blood eosinophils, serum IgE), oral corticosteroid (OCS) sparing effect in asthma patients, and treatment persistence.

Safety outcomes will assess the incidence, types, and severity of adverse events (AEs) and serious adverse events (SAEs). Exploratory endpoints include high-resolution CT (HRCT)-based imaging markers of airway remodeling and the development of deep learning-based multimodal predictive models integrating clinical, biomarker, and radiomics data to support personalized treatment. Additionally, blood, sputum, and urine samples will be collected for translational research to explore underlying mechanisms and predictors of biologic response.

This study aims to generate robust real-world evidence on the effectiveness and safety of Type 2-targeted biologics across the broad spectrum of chronic airway diseases in a diverse Chinese patient population.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Chronic airway diseases, encompassing asthma and chronic obstructive pulmonary disease (COPD) are heterogeneous disorders characterized by chronic airway inflammation, persistent airflow limitation, and/or airway hyperresponsiveness. These conditions commonly present with chronic cough, sputum production, and dyspnea. Acute exacerbations can be life-threatening and represent a leading global cause of disability and premature mortality among chronic non-communicable diseases.

Although inhaled corticosteroids (ICS) combined with long-acting bronchodilators (LABA/LAMA) form the mainstay of treatment, a substantial proportion of patients - approximately 5-10% with asthma and selected COPD patients experience severe or refractory disease. These patients suffer from recurrent exacerbations, progressive lung function decline, impaired quality of life, and serious complications associated with long-term oral corticosteroid (OCS) use, including osteoporosis and increased infection risk.

Type 2 (T2-high) inflammation, driven by eosinophil activation and the IL-4/IL-5/IL-13 signaling pathways, plays a central role in the pathogenesis of most severe asthma cases and a significant subset of COPD patients. In recent years, biologics targeting key mediators of Type 2 inflammation - including IgE, IL-5/IL-5Rα, IL-4Rα, and thymic stromal lymphopoietin (TSLP) - have emerged as precision therapeutic options for patients inadequately controlled on standard therapy.

The six biologics evaluated in this study are:

  1. Omalizumab (anti-IgE monoclonal antibody)
  2. Mepolizumab (anti-IL-5 monoclonal antibody)
  3. Benralizumab (anti-IL-5Rα monoclonal antibody)
  4. Dupilumab (anti-IL-4Rα monoclonal antibody, blocking IL-4/IL-13 signaling)
  5. Tezepelumab (anti-TSLP monoclonal antibody, effective in both T2-high and T2-low phenotypes)
  6. Depemokimab (ultra-long-acting anti-IL-5 Fc-fusion protein enabling twice-yearly dosing) Current international guidelines (GINA 2026 and GOLD 2026) recommend these Type 2-targeted biologics as add-on therapy for moderate-to-severe patients with poor control despite optimized standard care, with selection often guided by biomarkers such as blood eosinophils (EOS) and fractional exhaled nitric oxide (FeNO). While these agents have demonstrated efficacy in randomized controlled trials (RCTs) for severe asthma and eosinophilic COPD, robust real-world evidence remains limited, long-term use, diverse phenotypes, elderly patients, and those with multiple comorbidities. Moreover, data specific to Chinese populations are scarce. This prospective real-world observational study aims to address these evidence gaps.

研究の種類

観察的

入学 (推定)

538

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

  • 中国
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200437
        • 募集
        • Shanghai Pulmonary Hospital
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Yong-hua Gao, PhD

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

サンプリング方法

非確率サンプル

調査対象母集団

Adult patients with chronic airway diseases (asthma, COPD) who have received biologics targeting Type 2 inflammation

説明

Inclusion Criteria

Subjects must meet all of the following criteria:

1. Age ≥ 18 years; 2. Confirmed diagnosis of at least one of the following chronic airway diseases:

  1. Asthma: Diagnosed according to the 2025 GINA guidelines, with typical variable respiratory symptoms (wheeze, shortness of breath, chest tightness, or cough) and objective evidence of variable expiratory airflow limitation (positive bronchodilator reversibility test, positive bronchial provocation test, average daily PEF variability >10%, improvement in lung function after ICS treatment, or significant variability in lung function between two visits).
  2. Chronic Obstructive Pulmonary Disease (COPD): Diagnosed according to the 2026 GOLD guidelines, with symptoms of dyspnea, chronic cough, or sputum production, and/or history of exposure to risk factors, and post-bronchodilator FEV₁/FVC < 70%.

3. Meets clinical indications for biologic therapy as judged by a respiratory or allergy specialist according to current guidelines:

  1. Asthma: Poor control despite optimized high-dose ICS-LABA therapy, presence of allergic or eosinophilic inflammatory biomarkers, or severe/refractory disease requiring maintenance oral corticosteroids (OCS).
  2. COPD: Frequent exacerbations despite triple inhaled therapy (ICS + LABA + LAMA), with blood eosinophil count (EOS) ≥ 300/μL and chronic bronchitis phenotype.

4. The treating respiratory or allergy specialist has decided to initiate or switch to one of the following approved biologics targeting Type 2 inflammation, based on 2025 GINA and 2026 GOLD guidelines: omalizumab, mepolizumab, benralizumab, dupilumab, tezepelumab, or depemokimab (tezepelumab may be used in both Type 2 and non-Type 2 inflammation).

5. Able and willing to provide written informed consent and commit to at least 12 months of follow-up.

Exclusion Criteria

Subjects will be excluded if they meet any of the following criteria:

  1. Presence of severe or uncontrolled pulmonary or systemic diseases (e.g., active malignancy, autoimmune disease) or active infectious respiratory diseases (e.g., active pulmonary tuberculosis or infectious pneumonia);
  2. Pregnant, breastfeeding, or planning pregnancy during the study period;
  3. Known history of hypersensitivity or allergy to any component of the planned biologic agent;
  4. Expected life expectancy less than 12 months;
  5. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation (e.g., poor compliance or inability to complete follow-up).

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

コホートと介入

グループ/コホート
介入・治療
Adults with chronic airway diseases who have been treated with biologics
Patients with chronic airway diseases who have been treated with biologics targeting Type 2 inflammation and met the study's inclusion criteria
薬：Biologics targeting Type 2 inflammation
Biologics targeting Type 2 inflammation, including Omalizumab (anti-IgE monoclonal antibody), Mepolizumab (anti-IL-5 monoclonal antibody), Benralizumab (anti-IL-5Rα monoclonal antibody), Dupilumab (anti-IL-4Rα monoclonal antibody, blocking IL-4/IL-13 signaling), Tezepelumab (anti-TSLP monoclonal antibody, effective in both T2-high and T2-low phenotypes), Depemokimab (ultra-long-acting anti-IL-5 Fc-fusion protein enabling twice-yearly dosing)
他の名前：
  • 介入群
Adults with chronic airway diseases who received the standard of care
Adults with chronic airway diseases who received the standard of care as recommended by relevant guidelines
薬：Patients with asthma and copd who received standard of care
Patients with asthma and copd who received standard of care as recommended by relevant guidelines
他の名前：
  • 標準治療グループ

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
Annual rate of protocol-defined exacerbations of chronic airway disease over 12 months
時間枠：12 months
Number of protocol-defined exacerbations per participant-year during the 12-month follow-up. An exacerbation is defined according to the disease-specific international criteria applicable to the participant's primary diagnosis: GINA 2026 for asthma; GOLD 2026 for COPD; ERS 2025 for bronchiectasis; and ERS 2024 for allergic bronchopulmonary aspergillosis (ABPA). Events are ascertained from participant report, medical records, and investigator assessment at scheduled and unscheduled visits.
12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Time to first exacerbation;
時間枠：12 months
Exacerbations of chronic airway diseases as defined by international guidelines: GINA 2026 (asthma) and GOLD 2026 (COPD).
12 months
Frequency of severe exacerbations
時間枠：12 months
Severe exacerbations of chronic airway diseases as defined by international guidelines: GINA 2026 (asthma), GOLD 2026 (COPD), ERS 2025 (bronchiectasis), and ERS 2024 (ABPA)
12 months
Change from baseline in Asthma Control Test (ACT) total score at 3, 6, 9, 12 months
時間枠：12 months
The Asthma Control Test (ACT) is a 5-item patient-reported questionnaire assessing asthma control over the previous 4 weeks. Total score ranges from 5 to 25; higher scores indicate better asthma control. Change is calculated as 3, 6, 9, 12-month score minus baseline score.
12 months
Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) score at 3, 6, 9, 12 months
時間枠：12 months
The Asthma Control Questionnaire-6 (ACQ-6) assesses asthma symptom control. Each of 6 items is scored from 0 to 6; the total score is the mean of item scores and ranges from 0 to 6. Higher scores indicate worse asthma control. Change is 12-month score minus baseline score.
12 months
Change from baseline in COPD Assessment Test (CAT) total score at 3, 6, 9, 12 months
時間枠：12 months
The COPD Assessment Test (CAT) is an 8-item questionnaire. Total score ranges from 0 to 40; higher scores indicate worse health status. Change is 3, 6, 9, 12-month score minus baseline score.
12 months
Change from baseline in modified Medical Research Council (mMRC) dyspnea scale at 3, 6, 9, 12 months
時間枠：12 months
The modified Medical Research Council (mMRC) dyspnea scale ranges from 0 to 4; higher scores indicate more severe dyspnea. Change is 3, 6, 9, 12-month grade minus baseline grade.
12 months
Change from baseline in Quality of Life-Bronchiectasis Respiratory Symptoms Score (QoL-B RSS) at 3, 6, 9, 12 months
時間枠：12 months
The Quality of Life-Bronchiectasis (QoL-B) Respiratory Symptoms Score is a domain of the QoL-B questionnaire. Domain scores range from 0 to 100; higher scores indicate fewer respiratory symptoms / better health status. Change is 3, 6, 9, 12-month score minus baseline score. This instrument is only measured for patients with bronchiectasis.
12 months
Change from baseline in Bronchiectasis Impact Measure (BIM) total score at 12 months
時間枠：12 months
The Bronchiectasis Impact Measure (BIM) is a patient-reported instrument assessing the impact of bronchiectasis. Total score ranges from 0 to 100; higher scores indicate greater disease impact (worse outcome). Change is 3, 6, 9, 12-month score minus baseline score. This instrument is only measured for patients with bronchiectasis.
12 months
Change from baseline in Bronchiectasis Symptom Visual Analog Scale (BS-VAS) score at 3, 6, 9, 12 months
時間枠：12 months
The Bronchiectasis Symptom Visual Analog Scale (BS-VAS) measures overall bronchiectasis symptom burden on a 10-mm visual analog scale ranging from 0 to 10. Higher scores indicate worse symptoms. Change is 3, 6, 9, 12-month score minus baseline score. This instrument is only measured for patients with bronchiectasis.
12 months
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score at 3, 6, 9, 12 months
時間枠：12 months
The St. George's Respiratory Questionnaire (SGRQ) total score ranges from 0 to 100; higher scores indicate worse health-related quality of life. Administered to participants with asthma or COPD, and to participants with ABPA who have comorbid asthma. Change is 3, 6, 9, 12-month score minus baseline score.
12 months
Lung function parameters
時間枠：12 months
Lung function parameters (FEV₁, FVC, and FEV₁/FVC ratio);
12 months
Airway inflammation and immune biomarkers
時間枠：12 months
Airway inflammation and immune biomarkers (fractional exhaled nitric oxide [FeNO], peripheral blood eosinophil [EOS] count, and serum IgE levels)
12 months
Oral corticosteroid (OCS) sparing effect in asthma patients
時間枠：12 months
Oral corticosteroid (OCS) sparing effect in asthma patients during treatment duration
12 months
Treatment persistence rate of the biologics
時間枠：12 months
Treatment persistence rate of the biologics during treatment duration
12 months

その他の成果指標

結果測定
メジャーの説明
時間枠
Safety Objective
時間枠：12 months
To evaluate the incidence, types, and severity of adverse events (AEs) and serious adverse events (SAEs) occurring within 12 months of treatment with the different biologics in patients with chronic airway diseases.
12 months
Exploratory Objectives
時間枠：12 months
To explore novel endpoints for biologic treatment in chronic airway diseases, particularly imaging markers derived from high-resolution computed tomography (HRCT), such as airway wall thickness and functional small airway disease;
12 months
Discriminative performance (AUROC) of a multimodal deep-learning model for predicting protocol-defined treatment response at 12 months
時間枠：12 months
Area under the receiver operating characteristic curve (AUROC) for a pre-specified deep-learning model that integrates baseline clinical variables, biomarkers, and chest CT radiomics features to predict protocol-defined treatment response at 12 months. Treatment response is defined as absence of protocol-defined exacerbation during 12-month follow-up. Model input features and the response definition are specified in the statistical analysis plan. AUROC ranges from 0 to 1; higher values indicate better discrimination.
12 months

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

Shanghai Pulmonary Hospital, Shanghai, China

捜査官

  • 主任研究者：Gao Yong-hua, PhD, MD、Shanghai Pulmonary Hospital, Shanghai, China

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

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 (実際)

2026年7月30日

一次修了 (推定)

2029年3月31日

研究の完了 (推定)

2029年5月16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13日

最初の投稿 (実際)

2026年9月16日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月16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13日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • SHP2026-T2-AIR

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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いいえ

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