Airway InflammationISDC-IADNCT07493629
Immune Status and Disease Control of Inflammatory Airway Diseases
An observational study of Airway Inflammation and Chronic Obstructive Pulmonary Disease (COPD), run by First Affiliated Hospital of Ningbo University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Airway Inflammation, Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 1 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study included patients diagnosed with airway inflammatory diseases who were treated at the First Affiliated Hospital of Ningbo University.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang
chao Cao, Doctor, +86-0574-87089878, caodoctor@163.com
About this study
Official title: Association Between Immune Status and Disease Control in Patients With 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:
- Answer questions about their health and symptoms.
- Give blood samples
- Have lung function tests and other standard check-ups.
- share sleep study results. We will compare people with airway diseases to healthy volunteers to see how their immune systems differ.
Read the detailed description
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.
- 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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Disease, Bronchiectasis, Sleep Apnea, Obstructive, Aspergillosis, Allergic Bronchopulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline
Secondary outcomes (16)
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).
Measured: baseline
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.
Measured: baseline
Serum Lipid testing
Including serum total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides.
Measured: baseline
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).
Measured: baseline
Asthma Control Questionnaire
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.
Measured: baseline
AQLQ （Asthma Quality of Life Questionnaire） Score
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.
Measured: Baseline
Borg rating
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.
Measured: baseline
FACED Score
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.
Measured: baseline
CAT（COPD Assessment Test） Score
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.
Measured: baseline
SGRQ（St. George's Respiratory Questionnaire）Score
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.
Measured: baseline
mMRC（Modified Medical Research Council Dyspnea Scale）Score
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.
Measured: baseline
FEV1（Forced Expiratory Volume in 1 second）
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.
Measured: baseline
MMEF75/25（Maximal Mid-Expiratory Flow between 75% and 25% of FVC）
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.
Measured: baseline
FVC（Forced Vital Capacity）
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.
Measured: baseline
FEV1/FVC（Forced Expiratory Volume in 1 second to Forced Vital Capacity Ratio）
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%.
Measured: baseline
Fractional Exhaled Nitric Oxide (FeNO) Levels Measured by Standardized Analyzer
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493629
- Sponsor's protocol ID
- 2025-156A-01
- Acronym
- ISDC-IAD
- Status last verified
- Mar 2026
- First submitted
- 24 Aug 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Immune Status and Disease Control in Patients With Inflammatory Airway Diseases
- ClinicalTrials.gov ID
- NCT07493629
- Acronym / sponsor ID
- ISDC-IAD / 2025-156A-01
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Ningbo UniversityResearch network
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Answer questions about their health and symptoms.
- Give blood samples
- Have lung function tests and other standard check-ups.
- share sleep study results. We will compare people with airway diseases to healthy volunteers to see how their immune systems differ.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study included patients diagnosed with airway inflammatory diseases who were treated at the First Affiliated Hospital of Ningbo University.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
16 secondary outcomes
Sputum Microbiome Composition by Metagenomic Next-Generation Sequencing (mNGS)
Time frame: baseline
Sleep-Disordered Breathing Severity Measured by Polysomnography
Time frame: baseline
Serum Lipid testing
Time frame: baseline
Daytime Sleepiness in Obstructive Sleep Apnea Measured by Epworth Sleepiness Scale (ESS)
Time frame: baseline
Asthma Control Questionnaire
Time frame: baseline
AQLQ （Asthma Quality of Life Questionnaire） Score
Time frame: Baseline
Borg rating
Time frame: baseline
FACED Score
Time frame: baseline
CAT（COPD Assessment Test） Score
Time frame: baseline
SGRQ（St. George's Respiratory Questionnaire）Score
Time frame: baseline
mMRC（Modified Medical Research Council Dyspnea Scale）Score
Time frame: baseline
FEV1（Forced Expiratory Volume in 1 second）
Time frame: baseline
MMEF75/25（Maximal Mid-Expiratory Flow between 75% and 25% of FVC）
Time frame: baseline
FVC（Forced Vital Capacity）
Time frame: baseline
FEV1/FVC（Forced Expiratory Volume in 1 second to Forced Vital Capacity Ratio）
Time frame: baseline
Fractional Exhaled Nitric Oxide (FeNO) Levels Measured by Standardized Analyzer
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Inflammation and Chronic Obstructive Pulmonary Disease (COPD), run by First Affiliated Hospital of Ningbo University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact chao Cao, Doctor (+86-0574-87085233, caocdoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral Blood Immune Cell Subset Profiling by Mass Cytometry (CyTOF) (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.