AsthmaT2AIRNCT07823842
T2AIR: Real-World Efficacy and Safety of Biologics Targeting Type 2 Inflammation in Asthma and COPD
An observational study of Asthma and COPD (Chronic Obstructive Pulmonary Disease), run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Biologics targeting Type 2 inflammation
- How many people
- 538 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2026to 16 May 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with chronic airway diseases (asthma, COPD) who have received biologics targeting Type 2 inflammation
Who may be able to join
- 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:
- 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%.
- 3. 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).
Show all 9Show fewer
- 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.
Who cannot join
- Subjects will be excluded if they meet any of the following criteria:
- 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);
- Pregnant, breastfeeding, or planning pregnancy during the study period;
- Known history of hypersensitivity or allergy to any component of the planned biologic agent;
- Expected life expectancy less than 12 months;
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200437
Yong-hua Gao, PhD, +8617321278520, gaoyonghuahust@163.com
Changwei Wu, Bs.c, 021-65115006, gaoyonghuahust@163.com
About this study
Official title: 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.
Read more
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.
Read the detailed description
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:
- 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) 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.
- Being tested
- Biologics targeting Type 2 inflammation, Patients with asthma and copd who received standard of care
- Keywords
- asthma, copd, bronchiectasis, ABPA, Biologics, Type 2 inflammation
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologics targeting Type 2 inflammationDrug
Also called Interventional group
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)
Patients with asthma and copd who received standard of careDrug
Also called Standard of Care Group
Patients with asthma and copd who received standard of care as recommended by relevant guidelines
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Biologics targeting Type 2 inflammation | |
| 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 Receives: Drug: Patients with asthma and copd who received standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual rate of protocol-defined exacerbations of chronic airway disease over 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.
Measured: 12 months
Secondary outcomes (14)
Time to first exacerbation;
Exacerbations of chronic airway diseases as defined by international guidelines: GINA 2026 (asthma) and GOLD 2026 (COPD).
Measured: 12 months
Frequency of severe exacerbations
Severe exacerbations of chronic airway diseases as defined by international guidelines: GINA 2026 (asthma), GOLD 2026 (COPD), ERS 2025 (bronchiectasis), and ERS 2024 (ABPA)
Measured: 12 months
Change from baseline in Asthma Control Test (ACT) total score at 3, 6, 9, 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.
Measured: 12 months
Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) score at 3, 6, 9, 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.
Measured: 12 months
Change from baseline in COPD Assessment Test (CAT) total score at 3, 6, 9, 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.
Measured: 12 months
Change from baseline in modified Medical Research Council (mMRC) dyspnea scale at 3, 6, 9, 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.
Measured: 12 months
Change from baseline in Quality of Life-Bronchiectasis Respiratory Symptoms Score (QoL-B RSS) at 3, 6, 9, 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.
Measured: 12 months
Change from baseline in Bronchiectasis Impact Measure (BIM) total score at 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.
Measured: 12 months
Change from baseline in Bronchiectasis Symptom Visual Analog Scale (BS-VAS) score at 3, 6, 9, 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.
Measured: 12 months
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score at 3, 6, 9, 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.
Measured: 12 months
Lung function parameters
Lung function parameters (FEV₁, FVC, and FEV₁/FVC ratio);
Measured: 12 months
Airway inflammation and immune biomarkers
Airway inflammation and immune biomarkers (fractional exhaled nitric oxide [FeNO], peripheral blood eosinophil [EOS] count, and serum IgE levels)
Measured: 12 months
Oral corticosteroid (OCS) sparing effect in asthma patients
Oral corticosteroid (OCS) sparing effect in asthma patients during treatment duration
Measured: 12 months
Treatment persistence rate of the biologics
Treatment persistence rate of the biologics during treatment duration
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start30 Jul 2026
- Primary completion31 Mar 2029 (estimated)
- Study completion16 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 538 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Yong-hua, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Gao Yong-hua, PhD, MD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823842
- Sponsor's protocol ID
- SHP2026-T2-AIR
- Acronym
- T2AIR
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Cole J, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Mannent LP, Patel N, Staudinger HW, Yancopoulos GD, Mortensen ER, Akinlade B, Maloney J, Lu X, Bauer D, Bansal A, Robinson LB, Abdulai RM; BOREAS Investigators. Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts. N Engl J Med. 2023 Jul 20;389(3):205-214. doi: 10.1056/NEJMoa2303951. Epub 2023 May 21.
PubMed 37272521Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, Sproule S, Gilmartin G, Aurivillius M, Werkstrom V, Goldman M; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting beta2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115-2127. doi: 10.1016/S0140-6736(16)31324-1. Epub 2016 Sep 5.
PubMed 27609408Castro M, Corren J, Pavord ID, Maspero J, Wenzel S, Rabe KF, Busse WW, Ford L, Sher L, FitzGerald JM, Katelaris C, Tohda Y, Zhang B, Staudinger H, Pirozzi G, Amin N, Ruddy M, Akinlade B, Khan A, Chao J, Martincova R, Graham NMH, Hamilton JD, Swanson BN, Stahl N, Yancopoulos GD, Teper A. Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med. 2018 Jun 28;378(26):2486-2496. doi: 10.1056/NEJMoa1804092. Epub 2018 May 21.
PubMed 29782217Sciurba FC, Criner GJ, Christenson SA, Martinez FJ, Papi A, Roche N, Bourbeau J, Korn S, Bafadhel M, Han MK, Kolterer S, Miller K, Mouneimne D, Fletcher J, Mayer B, Min J, Pavord ID; MATINEE Study Investigators. Mepolizumab to Prevent Exacerbations of COPD with an Eosinophilic Phenotype. N Engl J Med. 2025 May 1;392(17):1710-1720. doi: 10.1056/NEJMoa2413181.
PubMed 40305712Jia N, Jin M, Liu Y, Su N, Sun Y, Tang W, Wang G, Xie H, Xie J, Xie M, Yao X, Zhang H, Chen R, Liu C, Li J. The management of type 2 inflammatory respiratory diseases: a Chinese expert consensus [2024]. J Thorac Dis. 2025 Apr 30;17(4):1807-1831. doi: 10.21037/jtd-2024-2092. Epub 2025 Mar 25.
PubMed 40400979Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, Adcock IM, Bateman ED, Bel EH, Bleecker ER, Boulet LP, Brightling C, Chanez P, Dahlen SE, Djukanovic R, Frey U, Gaga M, Gibson P, Hamid Q, Jajour NN, Mauad T, Sorkness RL, Teague WG. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014 Feb;43(2):343-73. doi: 10.1183/09031936.00202013. Epub 2013 Dec 12.
PubMed 24337046Bhatt SP, Agusti A, Bafadhel M, Christenson SA, Bon J, Donaldson GC, Sin DD, Wedzicha JA, Martinez FJ. Phenotypes, Etiotypes, and Endotypes of Exacerbations of Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2023 Nov 15;208(10):1026-1041. doi: 10.1164/rccm.202209-1748SO.
PubMed 37560988
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07823842
- Acronym / sponsor ID
- T2AIR / SHP2026-T2-AIR
- Keywords
- asthma, copd, bronchiectasis, ABPA, Biologics, Type 2 inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 538 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 16 May 2029 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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) 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults with chronic airway diseases who have been treated with biologics | – | Drug: Biologics targeting Type 2 inflammationPatients with chronic airway diseases who have been treated with biologics targeting Type 2 inflammation and met the study's inclusion criteria |
| Adults with chronic airway diseases who received the standard of care | – | Drug: Patients with asthma and copd who received standard of careAdults with chronic airway diseases who received the standard of care as recommended by relevant guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic airway diseases (asthma, COPD) who have received biologics targeting Type 2 inflammation
Key inclusion criteria (9 listed)
- 1. 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%.
- 3. 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).
Key exclusion criteria (6 listed)
- 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);
- Pregnant, breastfeeding, or planning pregnancy during the study period;
- Known history of hypersensitivity or allergy to any component of the planned biologic agent;
- Expected life expectancy less than 12 months;
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biologics targeting Type 2 inflammationAlso: Interventional groupBiologics 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) | Drug | Adults with chronic airway diseases who have been treated with biologics |
| Patients with asthma and copd who received standard of careAlso: Standard of Care GroupPatients with asthma and copd who received standard of care as recommended by relevant guidelines | Drug | Adults with chronic airway diseases who received the standard of care |
Primary outcome
Annual rate of protocol-defined exacerbations of chronic airway disease over 12 months
Time frame: 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.
14 secondary outcomes
Time to first exacerbation;
Time frame: 12 months
Frequency of severe exacerbations
Time frame: 12 months
Change from baseline in Asthma Control Test (ACT) total score at 3, 6, 9, 12 months
Time frame: 12 months
Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) score at 3, 6, 9, 12 months
Time frame: 12 months
Change from baseline in COPD Assessment Test (CAT) total score at 3, 6, 9, 12 months
Time frame: 12 months
Change from baseline in modified Medical Research Council (mMRC) dyspnea scale at 3, 6, 9, 12 months
Time frame: 12 months
Change from baseline in Quality of Life-Bronchiectasis Respiratory Symptoms Score (QoL-B RSS) at 3, 6, 9, 12 months
Time frame: 12 months
Change from baseline in Bronchiectasis Impact Measure (BIM) total score at 12 months
Time frame: 12 months
Change from baseline in Bronchiectasis Symptom Visual Analog Scale (BS-VAS) score at 3, 6, 9, 12 months
Time frame: 12 months
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score at 3, 6, 9, 12 months
Time frame: 12 months
Lung function parameters
Time frame: 12 months
Airway inflammation and immune biomarkers
Time frame: 12 months
Oral corticosteroid (OCS) sparing effect in asthma patients
Time frame: 12 months
Treatment persistence rate of the biologics
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 37272521Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Cole J, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Mannent LP, Patel N, Staudinger HW, Yancopoulos GD, Mortensen ER, Akinlade B, Maloney J, Lu X, Bauer D, Bansal A, Robinson LB, Abdulai RM; BOREAS Investigators. Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts. N Engl J Med. 2023 Jul 20;389(3):205-214. doi: 10.1056/NEJMoa2303951. Epub 2023 May 21.
- Background: PubMed 27609408Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, Sproule S, Gilmartin G, Aurivillius M, Werkstrom V, Goldman M; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting beta2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115-2127. doi: 10.1016/S0140-6736(16)31324-1. Epub 2016 Sep 5.
- Background: PubMed 29782217Castro M, Corren J, Pavord ID, Maspero J, Wenzel S, Rabe KF, Busse WW, Ford L, Sher L, FitzGerald JM, Katelaris C, Tohda Y, Zhang B, Staudinger H, Pirozzi G, Amin N, Ruddy M, Akinlade B, Khan A, Chao J, Martincova R, Graham NMH, Hamilton JD, Swanson BN, Stahl N, Yancopoulos GD, Teper A. Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med. 2018 Jun 28;378(26):2486-2496. doi: 10.1056/NEJMoa1804092. Epub 2018 May 21.
- Background: PubMed 40305712Sciurba FC, Criner GJ, Christenson SA, Martinez FJ, Papi A, Roche N, Bourbeau J, Korn S, Bafadhel M, Han MK, Kolterer S, Miller K, Mouneimne D, Fletcher J, Mayer B, Min J, Pavord ID; MATINEE Study Investigators. Mepolizumab to Prevent Exacerbations of COPD with an Eosinophilic Phenotype. N Engl J Med. 2025 May 1;392(17):1710-1720. doi: 10.1056/NEJMoa2413181.
- Background: PubMed 40400979Jia N, Jin M, Liu Y, Su N, Sun Y, Tang W, Wang G, Xie H, Xie J, Xie M, Yao X, Zhang H, Chen R, Liu C, Li J. The management of type 2 inflammatory respiratory diseases: a Chinese expert consensus [2024]. J Thorac Dis. 2025 Apr 30;17(4):1807-1831. doi: 10.21037/jtd-2024-2092. Epub 2025 Mar 25.
- Background: PubMed 24337046Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, Adcock IM, Bateman ED, Bel EH, Bleecker ER, Boulet LP, Brightling C, Chanez P, Dahlen SE, Djukanovic R, Frey U, Gaga M, Gibson P, Hamid Q, Jajour NN, Mauad T, Sorkness RL, Teague WG. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014 Feb;43(2):343-73. doi: 10.1183/09031936.00202013. Epub 2013 Dec 12.
- Background: PubMed 37560988Bhatt SP, Agusti A, Bafadhel M, Christenson SA, Bon J, Donaldson GC, Sin DD, Wedzicha JA, Martinez FJ. Phenotypes, Etiotypes, and Endotypes of Exacerbations of Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2023 Nov 15;208(10):1026-1041. doi: 10.1164/rccm.202209-1748SO.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gao Yong-hua, PhD, MD principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and COPD (Chronic Obstructive Pulmonary Disease), run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gao Yong-hua, PhD, MD (+8617321278520, gaoyonghuahust@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual rate of protocol-defined exacerbations of chronic airway disease over 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07823842, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.