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

13 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

538

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200437
        • Reclutamento
        • Shanghai Pulmonary Hospital
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Yong-hua Gao, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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
Droga: 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)
Altri nomi:
  • Gruppo interventista
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
Droga: 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
Altri nomi:
  • Gruppo standard di cura

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Annual rate of protocol-defined exacerbations of chronic airway disease over 12 months
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to first exacerbation;
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 12 months
Lung function parameters (FEV₁, FVC, and FEV₁/FVC ratio);
12 months
Airway inflammation and immune biomarkers
Lasso di tempo: 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
Lasso di tempo: 12 months
Oral corticosteroid (OCS) sparing effect in asthma patients during treatment duration
12 months
Treatment persistence rate of the biologics
Lasso di tempo: 12 months
Treatment persistence rate of the biologics during treatment duration
12 months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety Objective
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Investigatori

  • Investigatore principale: Gao Yong-hua, PhD, MD, Shanghai Pulmonary Hospital, Shanghai, China

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 luglio 2026

Completamento primario (Stimato)

31 marzo 2029

Completamento dello studio (Stimato)

16 maggio 2029

Date di iscrizione allo studio

Primo inviato

8 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 settembre 2026

Primo Inserito (Effettivo)

16 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SHP2026-T2-AIR

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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