Chronic Airway InflammationNCT06938022
Respiratory Microbiota, Infection Characteristics and Imaging Manifestations in Patients With Chronic Airway Inflammation
An observational study of Chronic Airway Inflammation and Asthma, run by First Affiliated Hospital of Ningbo University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Airway Inflammation, Asthma, Chronic Obstructive Pulmonary Disease
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 30 May 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age: 18 to 80 years old (inclusive), without restrictions on gender or ethnicity.
- 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.
- Disease Status:
Show all 16Show fewer
- 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.
- 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.
- 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.
Who cannot join
- 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.
- 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.
Show all 14Show fewer
- Disease Status:
- [1] Patients who have experienced any degree of acute exacerbation within the last 4 weeks before screening for the stable phase study.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Bronchiectasis
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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Baseline, Week 4 , Week 8 , and 3-month follow-up.
Secondary outcomes (30)
Changes in Airway Inflammation Markers
Detection of airway inflammatory factors by ELISA, such as IL-4, IL-5, IL-6, IL-8, IL-13, IL-33, TNF-α, IL-1β, etc.The concentration of Airway Inflammation Markers is measured in pg/mL.
Measured: Baseline, Week 4, Week 8 follow-up.
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, Week 4 , Week 8 , and 3-month follow-up.
PEF（Peak Expiratory Flow）
PEF is measured in liters per minute (L/min). It refers to the maximum flow rate that can be achieved when exhaling at the fastest speed after the maximum inspiration. This indicator can reflect how open the airway is.
Measured: Baseline, Week 4 , Week 8 , and 3-month follow-up.
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, Week 4 , Week 8 , and 3-month follow-up.
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, Week 4 , Week 8 , and 3-month follow-up.
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, Week 4 , Week 8 , and 3-month follow-up.
Blood Routine Test
Including CRP, WBC, Neu, Mono, Eos, RBC, Hb, and PLT.
Measured: Baseline, Week 4 , Week 8 follow-up.
Serum viral Antibody IgG
The serum viral antibody titer is measured by ELISA, which is a commonly used method for detecting and quantifying antibodies in patient samples. Then, these results will be used to analyze the relationship between viral infection and disease status, severity, or treatment response.
Measured: Baseline, Week 4 , Week 8 follow-up.
Anxiety Levels
Anxiety symptoms will be assessed using the Hamilton Anxiety Rating Scale (HAMA), a validated scale with scores ranging from 0 to 56, where higher scores indicate greater anxiety severity.
Measured: Baseline, Week 4 , Week 8 , and 3-month follow-up.
Depression Levels
Depressive symptoms will be observed using the Hamilton Depression Rating Scale (HAMD), which scores from 0 to 52, with higher scores indicating more severe depression.
Measured: Baseline, Week 4 , Week 8 , and 3-month follow-up.
Incidence of Serious Adverse Events (SAEs)
The safety will be assessed by monitoring and recording the incidence of treatment-emergent serious adverse events (SAEs) using the Serious Adverse Event Report Form (SAE Report). The research team will document, analyze, and provide appropriate medical responses to any incidents.
Measured: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
Number of Emergency Visits and Hospitalizations
Record the number of emergency visits and hospitalizations to evaluate the clinical effectiveness of treatment.
Measured: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
Number of Acute Exacerbations
The unit of Number of Acute Exacerbations is number of events. Total count of acute exacerbations experienced by participants.
Measured: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
Exacerbation Events
Acute exacerbation events of the disease will be assessed using Asthma, COPD, Bronchiectasis exacerbation records, recording the timing, frequency, and severity of each exacerbation. and grade the severity as mild, moderate, or severe.
Measured: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
Frequency of Emergency Department Visits
The number of emergency department visits due to acute exacerbations of Asthma, Chronic Obstructive Pulmonary Disease (COPD), and Bronchiectasis will be tracked using patients' self-reports and verified through medical records. This measure helps to evaluate the severity of the diseases.
Measured: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
Frequency of Hospitalizations
The number of people hospitalized due to acute exacerbations of Asthma, COPD (Chronic Obstructive Pulmonary Disease), and Bronchiectasis will be recorded, including detailed information such as the length of hospital stay and the treatments administered.
Measured: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
Severity Grading of Acute Exacerbations
The unit of Severity Grading of Acute Exacerbations is units on a severity scale. Severity of each acute exacerbation categorized by a standardized scale (e.g., mild/moderate/severe or graded numerically, such as Grade 1-3).
Measured: Baseline, Week 4, Week 8, 3-month, 6-month, 9-month, and 12-month follow-up.
Occurrence of Respiratory Failure
Documentation of respiratory failure events during hospital stays, including clinical criteria for diagnosis and management details.
Measured: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
Number of Moderate to Severe Acute Exacerbations
The unit of Number of Moderate to Severe Acute Exacerbations is number of events. Count of exacerbations classified as moderate or severe based on the severity grading scale.
Measured: Baseline, Week 4, Week 8, 3-month, 6-month, 9-month, and 12-month follow-up.
Use of Non-Invasive Ventilation
Documentation of the use of non-invasive ventilation during hospitalization, including indications and duration of use.
Measured: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
ICU Admission and Intubation
Records of ICU admissions and whether intubation was required during hospitalization, including associated clinical details.
Measured: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
Systemic Steroid Use
Documentation of systemic corticosteroid use during hospital stays, including dosage and duration.
Measured: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
Length of Hospital Stay
Total duration of each hospital stay will be recorded to assess the impact of the intervention on hospitalization length.
Measured: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
CAT（COPD Assessment Test） Score
It is used to evaluate the quality of life of COPD patients in groups other than the chronic airway inflammation ICS research group. It includes 8 items, involving dyspnea, exercise ability, cough, sputum, chest tightness, sleep quality, self - confidence and energy level. The scoring range is 0 - 10 points.
Grade division:
0 - 2 points: Mild. 3 - 5 points: Moderate. 6 - 10 points: Severe.
Measured: Baseline, Week 4 , Week 8 , and 3-month follow-up.
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, Week 4 , Week 8 , and 3-month follow-up.
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, Week 4 , Week 8 , and 3-month follow-up.
ACT（Asthma Control Test） Score
The ACT Score is used to evaluate the quality of life of asthma patients in groups other than the chronic airway inflammation ICS research group. The scoring range is 5 - 25 points.
Grade division:
20 - 25 points: Asthma is well - controlled. 16 - 19 points: Asthma is partially - controlled. Less than 16 points: Asthma is uncontrolled.
Measured: Baseline, Week 4 , Week 8 , and 3-month follow-up.
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, Week 4 , Week 8 , and 3-month follow-up.
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, Week 4 , Week 8 , and 3-month follow-up.
BEST（Bronchiectasis Evaluation Score for Treatment)）Score
The BEST Score is used to assess the symptoms of dyspnea and cough. 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, Week 4 , Week 8 , and 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Other
- Time perspective
- Other
- Enrolment
- 1,000 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
- NCT06938022
- Sponsor's protocol ID
- 2025-108A-01
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2025
- Last updated
- 22 Apr 2025
- 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 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06938022
- Acronym / sponsor ID
- 2025-108A-01
- Conditions
- Chronic Airway Inflammation, Asthma, Chronic Obstructive Pulmonary Disease, Bronchiectasis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Ningbo UniversityResearch network
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 22 Apr 2025 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- Age: 18 to 80 years old (inclusive), without restrictions on gender or ethnicity.
- 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.
Key exclusion criteria (14 listed)
- 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.
- 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.
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
Respiratory microorganisms
Time frame: Baseline, Week 4 (mid-intervention), and Week 8 (end of intervention) follow-up.
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
ACT（Asthma Control Test） Score
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
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.
CAT（COPD Assessment Test） Score
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
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.
30 secondary outcomes
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.
Number of Acute Exacerbations
Time frame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
Exacerbation Events
Time frame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
Frequency of Emergency Department Visits
Time frame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
Frequency of Hospitalizations
Time frame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
Severity Grading of Acute Exacerbations
Time frame: Baseline, Week 4, Week 8, 3-month, 6-month, 9-month, and 12-month follow-up.
Occurrence of Respiratory Failure
Time frame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
Number of Moderate to Severe Acute Exacerbations
Time frame: Baseline, Week 4, Week 8, 3-month, 6-month, 9-month, and 12-month follow-up.
Use of Non-Invasive Ventilation
Time frame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
ICU Admission and Intubation
Time frame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
Systemic Steroid Use
Time frame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
Length of Hospital Stay
Time frame: Baseline, Week 4, Week 8，3-month，6-month，9-month，and 12-month follow-up.
CAT（COPD Assessment Test） Score
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
SGRQ（St. George's Respiratory Questionnaire）Score
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
mMRC（Modified Medical Research Council Dyspnea Scale）Score
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
ACT（Asthma Control Test） Score
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
AQLQ（Asthma Quality of Life Questionnaire）Score
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
FACED Score
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
BEST（Bronchiectasis Evaluation Score for Treatment)）Score
Time frame: Baseline, Week 4 , Week 8 , and 3-month follow-up.
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 22 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Airway Inflammation
RecruitingPhase 4
A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
Chronic Obstructive Pulmonary Disease
RecruitingObservational study
T2AIR: Real-World Efficacy and Safety of Biologics Targeting Type 2 Inflammation in Asthma and COPD
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Active, not recruiting
Innate Immunity in Ozone-induced Airway Inflammation in COPD
Pulmonary Disease, Chronic Obstructive, Airway Disease
Recruiting
Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingObservational study
Immune Status and Disease Control of Inflammatory Airway Diseases
Airway Inflammation, Chronic Obstructive Pulmonary Disease (COPD)
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Airway Inflammation and Asthma, run by First Affiliated Hospital of Ningbo University.
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 16 inclusion and 14 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: opening soon, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 (+86-0574-87089878, caocdoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory microorganisms (time frame: Baseline, Week 4 (mid-intervention), and Week 8 (end of intervention) follow-up.). The study lists 3 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 22 Apr 2025.