Respiratory Microbiota, Infection Characteristics and Imaging Manifestations in Patients With Chronic Airway Inflammation

NCT06938022 | Not Yet Recruiting

• 1 other identifier: 2025-108A-01
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study，Respiratory microbiota, infection characteristics and imaging manifestations in patients with chronic airway inflammation， adopted a prospective, observational, multi-omics study design to comprehensively evaluate the effects of respiratory microbiota, infection characteristics and imaging manifestations on disease outcomes and quality of life in patients with chronic airway inflammation. Involving six parallel sub-studies, These include: (1) the differences and mechanisms of lung microecology in ICS treatment sensitivity and resistance in patients with chronic airway inflammation, (2) the study of respiratory viral infection and inflammatory markers in patients with acute exacerbation of chronic obstructive pulmonary disease, (3) the effect of respiratory viral infection on the airway inflammation and disease severity of asthma in acute exacerbation, (4) the clinical significance of fungal infection in acute exacerbation of bronchiectasis, (5) the role of pulmonary function test and chest CT in predicting acute exacerbation of chronic obstructive pulmonary disease, and (6) the predictive value of baseline pulmonary function and radiomics in acute exacerbation of bronchiectasis， Each sub-study targeted a different study purpose and a specific patient population. All sub-studies followed uniform research principles, including scientificity, ethics, and consistency. All subjects were required to sign an informed consent form before enrollment to ensure that they understood the purpose, process, possible risks and privacy protection measures of the study. The study plans to enroll about 1,000 eligible patients covering chronic airway inflammatory diseases such as asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis. In this study, multi-omics techniques, including microbiome, metabolomics, radiomics, and transcriptomics, were used to comprehensively evaluate the effects of respiratory microbiota, infection characteristics, and imaging manifestations on disease outcomes and quality of life in patients with chronic airway inflammation.

Conditions

Chronic Airway Inflammation; Asthma; Chronic Obstructive Pulmonary Disease; Bronchiectasis

Outcome Measures

Primary Outcomes (3)

• Respiratory microorganisms

  Multiplex RT-qPCR analysis was performed to analyze the microbial species and abundance of respiratory tract microorganisms in sputum samples, nasopharyngeal swabs or exhaled air condensate of patients with chronic airway inflammation

  Baseline, Week 4 (mid-intervention), and Week 8 (end of intervention) follow-up.

• ACT（Asthma Control Test） Score

  In the research group of ICS treatment sensitivity and resistance in Chronic Airway Inflammation, Asthma symptom control will be assessed using the Asthma Control Test (ACT), a validated questionnaire with scores ranging from 5 to 25. Higher scores indicate better asthma control.

  Baseline, Week 4 , Week 8 , and 3-month follow-up.

• CAT（COPD Assessment Test） Score

  In the research group of ICS treatment sensitivity and resistance in Chronic Airway Inflammation, Chronic Obstructive Pulmonary Disease Assessment Test（CAT) is a tool used to assess the severity of chronic obstructive pulmonary disease (COPD) and the quality of life of patients. The scoring range is 0 - 10 points. Grade division: 0 - 2 points: Mild. 3 - 5 points: Moderate. 6 - 10 points: Severe.

  Baseline, Week 4 , Week 8 , and 3-month follow-up.

Secondary Outcomes (30)

• Changes in Airway Inflammation Markers

  Baseline, Week 4, Week 8 follow-up.

• FEV1（Forced Expiratory Volume in 1 second）

  Baseline, Week 4 , Week 8 , and 3-month follow-up.

• PEF（Peak Expiratory Flow）

  Baseline, Week 4 , Week 8 , and 3-month follow-up.

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

  Baseline, Week 4 , Week 8 , and 3-month follow-up.

• FVC（Forced Vital Capacity）

  Baseline, Week 4 , Week 8 , and 3-month follow-up.

Study Arms (6)

ICS treatment sensitivity and resistance in Chronic Airway Inflammation

Using a prospective, single-center, observational study design, 240 patients were planned to be enrolled, divided into ICS-sensitive and resistant. Through multi-omics technologies such as 16S rRNA gene sequencing, metagenomic sequencing, and metabolomics analysis, the composition, structure and functional gene differences of airway and intestinal microbiota were analyzed, and the microbiota-metabolite-host network was constructed by combining inflammatory factor detection and transcriptomic analysis, and the complex mechanism of ICS treatment response was analyzed.

The study of respiratory viral infection and inflammatory markers in patients with acute exacerbatio

A prospective, open-label, self-controlled trial design was adopted, and 150 patients were expected to be included. RT-PCR was used to detect respiratory viruses, and ELISA was used to detect inflammatory markers, and the dynamic changes of viral infection and inflammatory markers and their association with clinical phenotypes were analyzed.

The effect of respiratory viral infection on the airway inflammation and disease severity of asthma

Patients aged 18-80 years with a clinical diagnosis of asthma exacerbation were included, nasopharyngeal swabs and sputum samples were collected for viral analysis, and ELISA was used to detect airway inflammation markers, and the number and severity of acute exacerbations, hospitalization and questionnaire scores were evaluated.

The clinical significance of fungal infection in acute exacerbation of bronchiectasis

A prospective, observational study design was used and 150 patients were expected to be included. The diversity and abundance of fungi in sputum were detected by 18S rRNA technology, and the inflammatory markers were detected by ELISA, and the relationship between fungal infection and clinical manifestations, questionnaire scores and inflammatory markers was analyzed.

The role of pulmonary function test and chest CT in predicting acute exacerbation of chronic obstruc

A prospective, observational cohort study design was adopted, and 200 patients were expected to be included. Pulmonary function tests, bronchodilator tests, chest CT scans, etc., were followed up for 1 year, and the changes in symptoms, acute exacerbations and all-cause mortality were recorded, and the biomarkers predicting acute exacerbations were analyzed using statistical models.

The predictive value of baseline pulmonary function and radiomics in acute exacerbation of bronchiec

A prospective, observational clinical trial design is adopted, and 150 patients are expected to be included. The clinical data, pulmonary function indexes and thin-slice CT scan results of the patients were collected, and the follow-up was 1 year, and the number of acute exacerbations, hospitalization and quality of life scores were recorded for statistical analysis.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a clinical diagnosis of chronic airway inflammation (including COPD, asthma, and bronchiectasis), aged 18-80 years, meeting the inclusion criteria and having no exclusion criteria.

You may qualify if:

• (1) Age: 18 to 80 years old (inclusive), without restrictions on gender or ethnicity.
• (2) Disease Diagnosis:
• COPD patients must meet the GOLD diagnostic criteria, with post-bronchodilator FEV1/FVC \< 70% and FEV1 \< 80% of the predicted value.
• Asthma patients must meet clinical diagnostic criteria, including recurrent wheezing, shortness of breath symptoms, frequently occurring at night; during attacks, wheezing sounds can be heard in both lungs; effective treatment with bronchodilators or corticosteroids, or symptoms can be relieved spontaneously, and at least one of the following tests must be positive: positive bronchial provocation test; positive bronchodilator test with FEV1 increase ≥12%, and FEV1 increase absolute value ≥200ml; daily peak expiratory flow (PEF) variability ≥10% within one week.
• Bronchiectasis patients must meet the diagnostic criteria based on CT imaging, including: bronchial diameter/accompanying pulmonary artery diameter ratio \>1; high-resolution CT (HRCT) showing dilated cystic, columnar, or cystic bronchial shadows.
• (3) Disease Status:
• Patients with chronic airway inflammation must be in a stable phase, defined as no acute exacerbations, hospitalizations, or use of other treatments for at least 4 weeks.
• COPD patients with acute exacerbations must meet the definition of acute exacerbation: at least two major symptoms (dyspnea, increased sputum, and purulent sputum) worsen, or at least one major symptom and one minor symptom (wheezing, sore throat, cough without other causes, and fever) worsen.
• Asthma patients in the acute attack phase must meet the definition of acute attack: sudden worsening of symptoms (including wheezing, shortness of breath, chest tightness, cough, etc.), decreased lung function, poor response to routine treatment, other clinically diagnosed acute attacks.
• Bronchiectasis patients with acute exacerbations must meet the definition of acute exacerbation: increased cough, increased sputum or sputum viscosity, purulent sputum, dyspnea or decreased exercise tolerance, fatigue or discomfort, hemoptysis, at least three of the above six symptoms occur newly or significantly worsen, lasting ≥48 hours.
• (4) Treatment Status:
• In the chronic airway inflammation patient ICS treatment study, patients must require ICS treatment under routine care, i.e., have been recommended to use ICS and are currently using ICS treatment.
• In other studies, patients must maintain unchanged long-term medication during the follow-up period, but may be appropriately adjusted according to the attending physician's clinical decision.
• (5) Others:
• All participants must voluntarily participate in the study and sign the informed consent form.

You may not qualify if:

• (1) Recent Medication Use:
• In the chronic airway inflammation patient ICS study, exclude patients who have used corticosteroid-related treatment within the last 3 months, exclude patients who have received antibiotic treatment within the last 3 months.
• In other studies, exclude patients who have used antibiotics, immunosuppressants, cytotoxic agents, or hormones systemically within the last 4 weeks.
• (2) Other Significant Diseases:
• Clinically significant pulmonary diseases other than the study disease, such as active tuberculosis, pulmonary embolism, pneumothorax, pneumothorax, pulmonary hypertension, interstitial lung disease, lung cancer, pulmonary fibrosis, tuberculosis, etc.
• Severe other systemic diseases, such as myocardial infarction, severe arrhythmia, liver dysfunction, renal insufficiency, rheumatic immune system diseases, hematological diseases, active malignant tumors, etc.
• (3) Disease Status:
• \[1\] Patients who have experienced any degree of acute exacerbation within the last 4 weeks before screening for the stable phase study.
• (4) Special Populations:
• Female patients who are pregnant or breastfeeding.
• Patients with poor compliance.
• Patients who cannot complete sample collection due to physical or psychological factors, especially those who need to collect multiple samples.
• Patients who are participating in other clinical trials. (5) Related Contraindications:
• \[1\] Patients with contraindications to pulmonary function tests and chest CT, such as chest metal, history of myocardial infarction, stroke, aortic aneurysm, or ocular surgery or retinal detachment within the last 3 months.

Sponsors & Collaborators

• First Affiliated Hospital of Ningbo University: lead

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chao Cao

CONTACT

+86-0574-87089878; caocdoctor@163.com

Shiyi He

CONTACT

+86-0574-87089878; shiyihii@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 22, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share