Immune Status and Disease Control of Inflammatory Airway Diseases

NCT07493629 | Recruiting

• 1 other identifier: 2025-156A-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Airway Inflammation; Chronic Obstructive Pulmonary Disease (COPD); Asthma (Diagnosis); Bronchiectasis; OSAS (Obstructive Sleep Apneas Syndrome); Allergic Bronchopulmonary Aspergillosis (ABPA)

Keywords

Airway Inflammatory Diseases; Immunophenotyping; Metabolomics; Cytometry by Time-of-Flight; High-dimensional immune profiling

Outcome Measures

Primary Outcomes (2)

• Peripheral Blood Immune Cell Subset Profiling by Mass Cytometry (CyTOF)

  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.

  baseline

• Serum Cytokine Levels by ELISA

  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.

  baseline

Secondary Outcomes (16)

• Sputum Microbiome Composition by Metagenomic Next-Generation Sequencing (mNGS)

  baseline

• Sleep-Disordered Breathing Severity Measured by Polysomnography

  baseline

• Serum Lipid testing

  baseline

• Daytime Sleepiness in Obstructive Sleep Apnea Measured by Epworth Sleepiness Scale (ESS)

  baseline

• Asthma Control Questionnaire

  baseline

Study Arms (6)

COPD group

The clinical diagnosis was COPD

Bronchiectasis group

The clinical diagnosis was Bronchiectasis

OSAS group

The clinical diagnosis was OSAS

Asthma group

The clinical diagnosis was asthma

ABPA group

The clinical diagnosis was ABPA

Health comparison

Healthy person without respiratory disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study included patients diagnosed with airway inflammatory diseases who were treated at the First Affiliated Hospital of Ningbo University.

You may qualify if:

• Age ≥18 years (≥40 years for COPD patients).
• Clinical diagnosis of asthma, ABPA, bronchiectasis, OSAS, or COPD according to established criteria.
• PRISm patients (post-BD FEV1/FVC ≥70% and FEV1 \<80% predicted)
• Smoking controls: ≥10 pack-years, normal lung function, no chronic respiratory symptoms.
• 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.

You may not qualify if:

• 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.
• 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.
• 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)
• Pregnant or lactating women.
• Patients with poor compliance as judged by the investigators.
• Subjects currently participating in other clinical studies.

Sponsors & Collaborators

• First Affiliated Hospital of Ningbo University: lead

Study Sites (1)

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

sputum and blood

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Disease; Bronchiectasis; Sleep Apnea, Obstructive; Aspergillosis, Allergic Bronchopulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Respiratory Tract Infections

Central Study Contacts

chao Cao, Doctor

CONTACT

+86-0574-87085233; caocdoctor@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: March 25, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)