Six biologics put to the test in Real-World asthma and COPD care
NCT ID NCT07823842
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are observing how six biologics that target Type 2 inflammation perform in adults with asthma or COPD during routine care in China. The study follows 538 participants for 12 months to measure flare-ups, lung function, symptom control, and safety. It also collects blood, sputum, and urine samples to look for markers that might predict who responds best to each biologic.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Biologics targeting Type 2 inflammation, including omalizumab, mepolizumab, benralizumab, dupilumab, tezepelumab, and depemokimab
- What this could lead to
- If these biologics hold up in routine care, doctors could better match each patient to the biologic most likely to cut flare-ups and spare oral steroids.
- What could go wrong
- This is an observational study, so it cannot prove cause and effect, and results from one Chinese population may not apply elsewhere. Real-world patients often differ from those in strict trials, which can muddy comparisons.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 538 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult patients with chronic airway diseases (asthma, COPD) who have received biologics targeting Type 2 inflammation
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Pulmonary Hospital
RECRUITINGShanghai, Shanghai Municipality, 200437, China
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