Immune Status and Disease Control of Inflammatory Airway Diseases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Ningbo University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 6 trial groups

6

Trial groups

See each trial group below.

Group A: COPD group
Group B: Bronchiectasis group
Group C: OSAS group
Group D: Asthma group
Group E: ABPA group
Group F: Health comparison

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline
2

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.

Time frame
baseline

Secondary outcomes

1

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

Sputum samples will be analyzed by metagenomic next-generation sequencing (mNGS) to characterize bacterial, fungal, and viral communities. Data will be aggregated as relative abundance (%) of microbial taxa and diversity indices (Shannon, Simpson).

Time frame
baseline
2

Sleep-Disordered Breathing Severity Measured by Polysomnography

For patients with OSAS and snoring, Apnea-Hypopnea Index (AHI), minimum SpO₂, and cumulative time with SpO₂ \< 90% (CT90) will be recorded overnight. Data will be summarized as mean values and categorized into mild, moderate, or severe OSAS.

Time frame
baseline
3

Serum Lipid testing

Including serum total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides.

Time frame
baseline
4

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

Epworth Sleepiness Scale (ESS): Evaluates daytime sleepiness severity; higher scores reflect greater impairment.Data will be summarized as mean total scores and categorized into severity levels (normal, mild, moderate, severe).

Time frame
baseline

Other outcomes

Sponsors and contacts

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