Immune status and disease control in airway inflammatory diseases

Association Between Immune Status and Disease Control in Patients With Inflammatory Airway Diseases

This project will test whether specific blood immune cell patterns relate to disease control in adults with asthma, COPD, bronchiectasis, or obstructive sleep apnea by comparing them with healthy volunteers.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Ningbo University (network)
• Locations: 1 site (Ningbo, Zhejiang)
• Trial ID: NCT07493629 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years, ≥40 for COPD) with a clinical diagnosis of asthma, ABPA, bronchiectasis, PRISm, OSAS, or COPD, or eligible smoking/healthy controls meeting the listed lung function and exposure criteria, are ideal candidates.

Not a fit: People with recent acute exacerbations (within 4 weeks), active lung cancer, severe comorbid systemic diseases, or other excluded respiratory conditions are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the project could identify immune markers that help predict disease control and guide more personalized management for airway inflammatory diseases.

How similar studies have performed: Prior studies using CyTOF and single-cell RNA sequencing have identified disease-associated immune signatures in individual respiratory conditions, but applying comprehensive high-dimensional profiling across multiple airway diseases in one cohort is relatively novel.

Eligibility criteria

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 this trial is running

Ningbo, Zhejiang

• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: chao Cao, Doctor

Conditions: Airway Inflammation, Chronic Obstructive Pulmonary Disease, Asthma, Bronchiectasis, OSAS, Allergic Bronchopulmonary Aspergillosis, Airway Inflammatory Diseases, Immunophenotyping