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

Official title

Chronic Airway Inflammation: The Impact of Respiratory Microbiota, Infection Characteristics, and Imaging Features on Disease Progression and Quality of Life-A Multomic and Comprehensive Study

Overview

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.

Primary outcome measures

• Respiratory microorganisms [Time frame: Baseline, Week 4 (mid-intervention), and Week 8 (end of intervention) follow-up.]
• ACT（Asthma Control Test） Score [Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.]
• CAT（COPD Assessment Test） Score [Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.]

Secondary outcome measures (12)

• Changes in Airway Inflammation Markers [Time frame: Baseline, Week 4, Week 8 follow-up.]
• FEV1（Forced Expiratory Volume in 1 second） [Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.]
• PEF（Peak Expiratory Flow） [Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.]
• MMEF75/25（Maximal Mid-Expiratory Flow between 75% and 25% of FVC） [Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.]
• FVC（Forced Vital Capacity） [Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.]
• FEV1/FVC（Forced Expiratory Volume in 1 second to Forced Vital Capacity Ratio） [Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.]
• Blood Routine Test [Time frame: Baseline, Week 4 , Week 8 follow-up.]
• Serum viral Antibody IgG [Time frame: Baseline, Week 4 , Week 8 follow-up.]
• Anxiety Levels [Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.]
• Depression Levels [Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.]
• Incidence of Serious Adverse Events (SAEs) [Time frame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.]
• Number of Emergency Visits and Hospitalizations [Time frame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.]

Eligibility criteria

Inclusion criteria

(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.
• Patients must be able to communicate in language or writing, understand and sign the content of the informed consent form, and be able to complete the required pulmonary function and other auxiliary examinations for the trial.

Exclusion criteria

(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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06938022 · 2025-108A-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗