Immune status and disease control in airway inflammatory diseases

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 is a prospective, single-center observational cohort recruiting about 205–215 participants across multiple airway inflammatory disease groups and matched healthy controls. Participants provide clinical data, lung function and sleep study results, sputum samples, and blood for PBMC isolation. High-dimensional single-cell technologies including CyTOF, scRNA-seq, and cytokine assays will be used to map immune cell phenotypes and states, while sputum NGS will profile microbial colonization. Immune profiles will be correlated with disease type, severity, and control using established clinical scores and functional measures.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Age ≥18 years (≥40 years for COPD patients).
2. Clinical diagnosis of asthma, ABPA, bronchiectasis, OSAS, or COPD according to established criteria.
3. PRISm patients (post-BD FEV1/FVC ≥70% and FEV1 \<80% predicted)
4. Smoking controls: ≥10 pack-years, normal lung function, no chronic respiratory symptoms.
5. Healthy controls: normal lung function, FeNO \<20 ppb, total IgE \<100 IU/mL, no chronic disease, smoking \<10 pack-years, no immunosuppressant use within 3 months.

Exclusion Criteria

1. Patients with severe respiratory diseases other than those included in the study, such as pulmonary embolism, pneumothorax, pulmonary hypertension, interstitial lung disease, or active lung cancer.
2. Patients with severe systemic diseases that may interfere with study completion, such as myocardial infarction, severe arrhythmia, hepatic insufficiency, renal insufficiency, hematological disorders, or malignancy.
3. Patients with an acute exacerbation within 4 weeks before enrollment, or systemic use of antibiotics, antifungal drugs, immunosuppressive agents, cytotoxic agents, or corticosteroids (except for long-term maintenance therapy)
4. Pregnant or lactating women.
5. Patients with poor compliance as judged by the investigators.
6. Subjects currently participating in other clinical studies.

Where it's running

• The First Affiliated Hospital of Ningbo University
  Ningbo, Zhejiang, China Recruiting

Study contacts

• Study coordinator: chao Cao, Doctor
• Email: caocdoctor@163.com
• Phone: +86-0574-87085233

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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.