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NCT Number: NCT07493629

Immune Status and Disease Control of Inflammatory Airway Diseases

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.

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Key information

Conditions

Airway Inflammation Allergic Bronchopulmonary Aspergillosis (ABPA) Apnea Aspergillosis Aspergillosis, Allergic Bronchopulmonary Asthma Asthma (Diagnosis) Bacterial Infections and Mycoses Bronchial Diseases Bronchiectasis Chronic Disease Chronic Obstructive Pulmonary Disease (COPD) Disease Disease Attributes Dyssomnias Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Fungal Lung Diseases, Obstructive Mycoses Nervous System Diseases OSAS (Obstructive Sleep Apneas Syndrome) Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Aspergillosis Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Location status: Recruiting

Location contact

chao Cao, Doctor

CONTACT

[email protected]

+86-0574-87089878

About this study

This prospective, single-center observational cohort study aims to comprehensively characterize the immune landscape of patients with chronic airway inflammatory diseases through the application of high-dimensional single-cell technologies.The study plans to enroll approximately 205 to 215 participants, comprising multiple disease groups and matched healthy controls.

A core methodological innovation of this study is the use of CyTOF (Cytometry by Time-Of-Flight), a mass cytometry platform capable of simultaneously analyzing up to 40-100 immune markers at the single-cell level. This approach allows for a highly detailed phenotypic and functional profiling of peripheral blood mononuclear cells (PBMCs), enabling the discovery of disease-associated immune cell subsets with greater resolution than conventional flow cytometry.

Participants will be stratified by disease type and severity based on clinical diagnostic criteria, functional testing (e.g., FEV1, AHI, FeNO), and established clinical scores (e.g., ACQ, CAT, GOLD, SGRQ, E-FACED). Blood samples will be processed for PBMC isolation and subjected to CyTOF analysis. Complementary assessments include cytokine profiling via ELISA, single-cell RNA sequencing (scRNA-seq) for transcriptomic insights, and sputum analysis via culture and next-generation sequencing (NGS) to evaluate microbial colonization and inflammatory cell profiles.

This study will investigate the correlation between immune phenotypes and clinical control levels, disease severity, hypoxia metrics, and inflammatory mediators (e.g., IL-6, TNF-α). It also seeks to identify key immunopathological features that may differentiate subtypes within each disease (e.g., T2-high vs. T2-low asthma; Pseudomonas-positive vs. negative bronchiectasis) and evaluate transitional states such as PRISm in relation to COPD progression. Multivariate models combining immune and clinical parameters will be developed to facilitate predictive stratification and to guide future individualized immunotherapeutic strategies.

By integrating CyTOF, scRNA-seq, and clinical data, this protocol aspires to define immune biomarkers predictive of airway disease control and severity and to provide a systems-level understanding of immune dysfunction across heterogeneous respiratory disorders.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

  2. Serum Cytokine Levels by ELISA

    Time frame: 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.

Secondary outcomes

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

    Time frame: baseline

    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).

  2. Sleep-Disordered Breathing Severity Measured by Polysomnography

    Time frame: baseline

    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.

  3. Serum Lipid testing

    Time frame: baseline

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

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

    Time frame: baseline

    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).

  5. Asthma Control Questionnaire

    Time frame: baseline

    In the asthma and ABPA research groups, the Asthma Control Questionnaire (ACQ) will be used to evaluate the control of asthma symptoms. ACQ is a validated questionnaire, with each question scoring 0-6 points. The average score will be calculated, with ≤ 0.75 indicating good control, 0.75-1.5 indicating partial control, and>1.5 indicating uncontrolled.

  6. AQLQ （Asthma Quality of Life Questionnaire） Score

    Time frame: Baseline

    The Asthma Quality of Life Questionnaire is used to evaluate the quality of life of asthma patients. The scoring range is 1 - 7 points. The higher the score, the better the quality of life.

  7. Borg rating

    Time frame: baseline

    The Borg score is used to evaluate the degree of respiratory distress in patients with bronchiectasis, measuring their perceived physical activity or intensity using numbers. Subjective fatigue and respiratory distress are quantified on a 0-10 point scale, with higher scores indicating more severe respiratory distress.

  8. FACED Score

    Time frame: baseline

    FACED Score includes Forced Expiratory Volume in 1 second (FEV1)、Age、 Chronic colonization by Pseudomonas aeruginosa (PA)、Extension (number of pulmonary lobes affected)、Dyspnea (mMRC score).It is used to assess the severity of bronchiectasis. The scoring range is from 0 to 10 points. Grade classification: 0 - 2 points: Mild. 3 - 5 points: Moderate. 6 - 10 points: Severe.

  9. CAT（COPD Assessment Test） Score

    Time frame: baseline

    A tool used in the bronchiectasis group to assist in assessing the severity and quality of life of patients with bronchiectasis. The rating range is 0-10 points. Grade classification: 0-2 points: Mild; 3-5 points: moderate; 6-10 points: severe.

  10. SGRQ（St. George's Respiratory Questionnaire）Score

    Time frame: baseline

    The SGRQ is used to evaluate the quality of life of patients with chronic respiratory diseases. It consists of three parts: symptoms, activities, and impact on daily life. The scoring range is 0 - 100 points. The higher the total score, the poorer the patient's quality of life.

  11. mMRC（Modified Medical Research Council Dyspnea Scale）Score

    Time frame: baseline

    The mMRC Score is used to assess the severity of dyspnoea and is divided into grades 0 - 4. The higher the score, the more severe the dyspnoea. Grade 0: Dyspnoea occurs only during strenuous exercise. Grade 1: Dyspnoea occurs when walking fast on flat ground or climbing a gentle slope. Grade 2: Dyspnoea causes the patient to stop and rest when walking on flat ground. Grade 3: Dyspnoea causes the patient to stop and rest after walking less than 100 metres or for a few minutes on flat ground. Grade 4: The patient is unable to leave home due to dyspnoea, or dyspnoea occurs when dressing or undressing.

  12. FEV1（Forced Expiratory Volume in 1 second）

    Time frame: baseline

    Pulmonary function FEV1 index was evaluated in liters (L). It refers to the volume of air exhaled in the first second by the subject exhaling at the fastest rate after the maximum inspiration.

  13. MMEF75/25（Maximal Mid-Expiratory Flow between 75% and 25% of FVC）

    Time frame: baseline

    MMEF75/25 is measured in liters per minute (L/min). This is the average expiratory flow rate over the course of 75% to 25% of the forced expiratory volume. It is primarily used to assess the function of the small airways.

  14. FVC（Forced Vital Capacity）

    Time frame: baseline

    FVC is measured in liters (L). It is the maximum volume of air that can be exhaled by exhaling forcefully as fast as possible after the maximum inhalation. This indicator reflects the ventilatory function of the lungs. FVC is generally around 3.5 - 5 L in normal adult males and slightly lower in females. FVC can be used to assess the elasticity of the lungs, the patency of the airways, etc.

  15. FEV1/FVC（Forced Expiratory Volume in 1 second to Forced Vital Capacity Ratio）

    Time frame: baseline

    The unit of FEV1/FVC is %. It is mainly used to determine if there is an airflow obstruction. Normally, FEV1/FVC should be greater than 70%.

  16. Fractional Exhaled Nitric Oxide (FeNO) Levels Measured by Standardized Analyzer

    Time frame: baseline

    FeNO will be measured in exhaled air and reported in parts per billion (ppb). Data will be summarized as mean values to reflect airway inflammation.

Study contacts

Contact information is provided by the study sponsor or research team.

chao Cao, Doctor

CONTACT

[email protected]

+86-0574-87085233

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Ningbo University

Network

Registry information

Official study title

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

Acronym: ISDC-IAD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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