Clinical trial NCT06938022: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Airway Inflammation
Asthma
Chronic Obstructive Pulmonary Disease
Bronchiectasis
Lead sponsor: First Affiliated Hospital of Ningbo University
Sponsor class: NETWORK
First posted: 2025-04-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.


Eligibility criteria: Inclusion Criteria:

(1) Age: 18 to 80 years old (inclusive), without restrictions on gender or ethnicity.

(2) Disease Diagnosis:

1. COPD patients must meet the GOLD diagnostic criteria, with post-bronchodilator FEV1/FVC \< 70% and FEV1 \< 80% of the predicted value.
2. 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.
3. 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:

1. 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.
2. 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.
3. 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.
4. 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:

1. 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.
2. 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:

1. All participants must voluntarily participate in the study and sign the informed consent form.
2. 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:

1. 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.
2. In other studies, exclude patients who have used antibiotics, immunosuppressants, cytotoxic agents, or hormones systemically within the last 4 weeks.

(2) Other Significant Diseases:

1. 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.
2. 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:

1. Female patients who are pregnant or breastfeeding.
2. Patients with poor compliance.
3. Patients who cannot complete sample collection due to physical or psychological factors, especially those who need to collect multiple samples.
4. 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.

Primary outcomes:
measure: Respiratory microorganisms
timeFrame: Baseline, Week 4 (mid-intervention), and Week 8 (end of intervention) follow-up.
measure: ACT（Asthma Control Test） Score
timeFrame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
measure: CAT（COPD Assessment Test） Score
timeFrame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
Secondary outcomes:
measure: Changes in Airway Inflammation Markers
timeFrame: Baseline, Week 4, Week 8 follow-up.
measure: FEV1（Forced Expiratory Volume in 1 second）
timeFrame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
measure: PEF（Peak Expiratory Flow）
timeFrame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
measure: MMEF75/25（Maximal Mid-Expiratory Flow between 75% and 25% of FVC）
timeFrame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
measure: FVC（Forced Vital Capacity）
timeFrame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
measure: FEV1/FVC（Forced Expiratory Volume in 1 second to Forced Vital Capacity Ratio）
timeFrame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
measure: Blood Routine Test
timeFrame: Baseline, Week 4 , Week 8 follow-up.
measure: Serum viral Antibody IgG
timeFrame: Baseline, Week 4 , Week 8 follow-up.
measure: Anxiety Levels
timeFrame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
measure: Depression Levels
timeFrame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
measure: Number of Emergency Visits and Hospitalizations
timeFrame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
measure: Number of Acute Exacerbations
timeFrame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
measure: Exacerbation Events
timeFrame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
measure: Frequency of Emergency Department Visits
timeFrame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
measure: Frequency of Hospitalizations
timeFrame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
measure: Severity Grading of Acute Exacerbations
timeFrame: Baseline, Week 4, Week 8, 3-month, 6-month, 9-month, and 12-month follow-up.
measure: Occurrence of Respiratory Failure
timeFrame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
measure: Number of Moderate to Severe Acute Exacerbations
timeFrame: Baseline, Week 4, Week 8, 3-month, 6-month, 9-month, and 12-month follow-up.
measure: Use of Non-Invasive Ventilation
timeFrame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
measure: ICU Admission and Intubation
timeFrame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
measure: Systemic Steroid Use
timeFrame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
measure: Length of Hospital Stay
timeFrame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
measure: CAT（COPD Assessment Test） Score
timeFrame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
measure: SGRQ（St. George's Respiratory Questionnaire）Score
timeFrame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
measure: mMRC（Modified Medical Research Council Dyspnea Scale）Score
timeFrame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
measure: ACT（Asthma Control Test） Score
timeFrame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
measure: AQLQ（Asthma Quality of Life Questionnaire）Score
timeFrame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
measure: FACED Score
timeFrame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
measure: BEST（Bronchiectasis Evaluation Score for Treatment)）Score
timeFrame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
Other outcomes:
Locations:
Study officials:
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