Real-life study of Type 2 inflammation biologics in asthma and COPD
Follows adults with asthma or COPD treated with biologics in routine care.
Plain-language title generated from the registry record
Registry title: T2AIR: Real-World Efficacy and Safety of Biologics Targeting Type 2 Inflammation in Asthma and COPD
Key facts
- Where
- Shanghai, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with asthma or COPD whose specialist has decided to start or switch to a Type 2 biologic drug. They are followed for at least 12 months.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Asthma that is poorly controlled despite optimized high-dose ICS-LABA, with allergic or eosinophilic markers, or severe asthma needing daily oral corticosteroids. COPD with frequent exacerbations despite triple inhaled therapy (ICS + LABA + LAMA), blood eosinophils ≥ 300/μL and chronic bronchitis.
- Earlier treatment
- People with COPD must have had triple inhaled therapy (ICS + LABA + LAMA). People with asthma must have had optimized high-dose ICS-LABA therapy. The specialist must plan to start or switch to omalizumab, mepolizumab, benralizumab, dupilumab, tezepelumab or depemokimab.
- Biomarker or test result
- For COPD: blood eosinophil count of 300/μL or more. For asthma: allergic or eosinophilic inflammation markers, unless the asthma is severe and needs oral corticosteroids.
Main reasons for not taking part
- Severe or uncontrolled lung or other body disease, such as active cancer or autoimmune disease
- Active lung infection, such as active tuberculosis or infectious pneumonia
- Pregnant, breastfeeding, or planning pregnancy during the study
- Known allergy to any part of the planned biologic drug
- Expected life expectancy under 12 months
Read by machine on 12 November 2026.
Where in China
- Shanghai Pulmonary HospitalShanghai, ChinaContact: Yong-hua Gao, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai Pulmonary Hospital, Shanghai, China
- Trial code
- NCT07823842
- Record updated
- 16 September 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Subjects must meet all of the following criteria:; Age ≥ 18 years; 2. Confirmed diagnosis of at least one of the following chronic airway diseases:; 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); 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%; Meets clinical indications for biologic therapy as judged by a respiratory or allergy specialist according to current guidelines:; 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); COPD: Frequent exacerbations despite triple inhaled therapy (ICS + LABA + LAMA), with blood eosinophil count (EOS) ≥ 300/μL and chronic bronchitis phenotype; 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); Able and willing to provide written informed consent and commit to at least 12 months of follow-up.
Exclusion: 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); Known history of hypersensitivity or allergy to any component of the planned biologic agent; 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); Subjects will be excluded if they meet any of the following criteria:; Pregnant, breastfeeding, or planning pregnancy during the study period; Expected life expectancy less than 12 months.