---
title: Immune Status and Disease Control of Inflammatory Airway Diseases
nct_id: NCT07493629
overall_status: RECRUITING
sponsor: First Affiliated Hospital of Ningbo University
study_type: OBSERVATIONAL
primary_condition: Airway Inflammation
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07493629.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07493629"
ct_last_update_post_date: 2026-03-25
last_seen_at: "2026-05-12T07:10:09.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Immune Status and Disease Control of Inflammatory Airway Diseases

**Official Title:** Association Between Immune Status and Disease Control in Patients With Inflammatory Airway Diseases

**NCT ID:** [NCT07493629](https://clinicaltrials.gov/study/NCT07493629)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** First Affiliated Hospital of Ningbo University
- **Conditions:** Airway Inflammation, Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis), Bronchiectasis, OSAS (Obstructive Sleep Apneas Syndrome), Allergic Bronchopulmonary Aspergillosis (ABPA)
- **Start Date:** 2025-08-01
- **Completion Date:** 2026-08-01
- **CT.gov Last Update:** 2026-03-25

## 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. 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.

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

- **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

## Primary Outcomes

- **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.

## 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)_

## Locations (1)

- The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the first affiliated hospital of ningbo university|ningbo|zhejiang|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07493629.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07493629*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*