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Clinical Trials in China / NCT07493629
Recruiting Observational

Immune Status and Disease Control of Inflammatory Airway Diseases

NCT07493629 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital of Ningbo University
Phase
Observational
Started
2025-08-01
Last updated
2026-03-25

Condition(s) studied

Airway InflammationChronic Obstructive Pulmonary Disease (COPD)Asthma (Diagnosis)BronchiectasisOSAS (Obstructive Sleep Apneas Syndrome)Allergic Bronchopulmonary Aspergillosis (ABPA)

Study summary

The goal of this study is to learn how the body's immune system affects disease control in people with different airway inflammatory diseases.We want to understand:

1.Whether specific immune cell patterns in the blood are linked to how severe the disease is or how well it is controlled.

Participants will:

1. Answer questions about their health and symptoms.
2. Give blood samples
3. Have lung function tests and other standard check-ups.
4. share sleep study results. We will compare people with airway diseases to healthy volunteers to see how their immune systems differ.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Peripheral Blood Immune Cell Subset Profiling by Mass Cytometry (CyTOF) — baseline
    Peripheral blood mononuclear cells (PBMCs) will be analyzed by CyTOF using a 41-marker antibody panel (includingCD4, CD8, HLA-DR, CD25, CD127, CD45RA, CD38, CD66b, IgD,etc.) The outcome will be reported as the relative frequency (%) and absolute counts of defined immune subsets, including T cell subsets (Th1, Th2, Th17, Treg, Tfh, cytotoxic T cells), B cell subsets (naive, memory, B1a, transitional), NK cells, myeloid cells, plasmablasts, monocytes, MDSCs, and granulocytes. Functional phenotypes such as activation (HLA-DR), exhaustion (PD-1), and aging (CD57) will also be quantified.
  • Serum Cytokine Levels by ELISA — baseline
    Plasma cytokines (e.g., IL-6, TNF-α, IL-10) will be quantified using ELISA. Data will be reported as absolute concentrations (pg/mL) and compared across disease subgroups.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Ningbo University Ningbo Zhejiang Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07493629 on ClinicalTrials.gov ↗ ← All trials in China