Biologics for Type 2 Inflammation in Asthma and COPD in Real World

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study evaluates the long-term safety and effectiveness of six biologics that target Type 2 inflammation in patients with asthma and COPD managed in standard clinical practice in China. The primary aim is to measure the annualized exacerbation rate over 12 months. Secondary goals include time to first exacerbation, rate of severe exacerbations, symptom control and quality of life, lung function (FEV1, FVC), airway biomarkers (FeNO, eosinophils, IgE), steroid-sparing effects in asthma, and treatment persistence. Safety will document adverse events and serious adverse events, with exploratory endpoints including high-resolution CT imaging. Eligible adults receive biologic therapy per current indications, with data collected under routine care settings at Shanghai Pulmonary Hospital.

Why it matters

Who can join: the full rules

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).

Where it's running

• Shanghai Pulmonary Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Gao Yong-hua, PhD, MD — Shanghai Pulmonary Hospital, Shanghai, China
• Study coordinator: Gao Yong-hua, PhD, MD
• Email: gaoyonghuahust@163.com
• Phone: +8617321278520

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Enhanced COPD care for people being checked for lung cancer

  This project will test whether finding and treating COPD early in people being checked for possible lung cancer helps symptoms, lung function, and overall care.

  Recruiting Region of Southern Denmark · Vejle · NCT07543601

• Chronic Respiratory Disease Participant Engagement

  This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.

  Recruiting Richmond Pharmacology Limited · London · NCT07924462

• HB0056 in adults with moderate to severe asthma

  This study tests HB0056 versus a placebo to see if it helps adults with moderate to severe asthma reduce rescue inhaler use and improve symptoms.

  Recruiting at 2 sites Phase 1/2 Shanghai Huaota Biopharmaceutical Co., Ltd. · Beijing and 1 other locations · NCT07899996

• Tilrekimig (PF-07275315) for Severe Asthma: Aimed at Adults with Frequent Exacerbations

  This study tests whether tilrekimig helps people with severe asthma who have had multiple flare-ups in the past year, by comparing it to a placebo given every four weeks.

  Recruiting at 4 sites Phase 3 Pfizer · River Forest, Illinois and 11 other locations · NCT07869043

• High-Flow Nasal Cannula vs Noninvasive Ventilation in COPD with Hypercapnia

  This study tests whether a high-flow nasal cannula can better support gas exchange and comfort compared with noninvasive ventilation in COPD patients with mild-to-moderate elevated CO2.

  Recruiting Mansoura University · Al Mansurah, Dakahlia Governorate · NCT07854210

• Inhaled CHF10136 safety and pharmacokinetics in healthy adults and adults with asthma

  This first-in-human study tests inhaled CHF10136 to see if it is safe and well tolerated, how it behaves in the body, and how it affects adults with asthma compared with placebo.

  Recruiting Phase 1 Chiesi Farmaceutici S.p.A. · Leeds and 2 other locations · NCT07851623

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.