Environmental ExposureNCT07313904
Effects of Environmental Fungal Exposure on Bronchial Asthma, ABPA and Bronchiectasis
An observational study of Environmental Exposure and Asthma, run by First Affiliated Hospital of Ningbo University at 1 site in China.
Trial summary
This study is a prospective, observational study of patients aged 18-80 years with clinical diagnosis of bronchial asthma, allergic bronchopulmonary aspergillosis (ABPA), bronchiectasis and healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposure, Asthma, Bronchiectasis
- How many people
- 125 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2025to 30 Jun 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: No bronchial asthma ABPA、 Healthy individuals aged 18-80 with bronchiectasis or other respiratory diseases
Who may be able to join
- Age range of 18-80 years old (including 18 and 80 years old), gender and race are not limited;
- No history of asthma, ABPA, or other chronic respiratory diseases.
- No history of allergic diseases, such as allergic rhinitis, eczema, or food allergies.
- Pulmonary function is normal or close to the normal range.
- Laboratory testing:
- 1. Blood routine: High sensitivity C-reactive protein, white blood cells, neutrophils, lymphocytes, and monocytes are all within the normal range.
- Allergen testing: IgE levels for common allergens such as dust mites, cat hair, dog hair, cockroaches, mold, and pollen are normal or close to the normal range.
Who cannot join
- Suffering from bronchial asthma ABPA、 Bronchiectasis or other respiratory diseases: chronic obstructive pulmonary disease, active pulmonary tuberculosis, pulmonary embolism, lung cancer, pneumothorax, hemoptysis, pulmonary arterial hypertension, interstitial lung disease, etc;
- Cancer patients who suffer from serious other systemic diseases, such as myocardial infarction, stroke, hypertensive crisis or refractory hypertension, severe arrhythmia, heart failure, aortic aneurysm, liver failure, renal failure, hematological disorders, etc., and have recently been discovered or are currently receiving treatment;
- Four weeks prior to enrollment, systemic use of antibiotics, antifungal drugs, immunosuppressants, cytotoxic agents, hormones, etc;
- Other individuals with contraindications for induced sputum testing:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang Recruiting
Ningbo, Zhejiang, 315010
Chao CAO, +86-0574-87089878, caodoctor@163.com
Shiyi He, +86-0574-87089878, shiyihii@163.com
About this study
Official title: Effects of Environmental Fungal Exposure on Bronchial Asthma, Allergic Bronchopulmonary Aspergillosis (ABPA), and Bronchiectasis
This study is a prospective, observational study of patients aged 18-80 years with clinical diagnosis of bronchial asthma, allergic bronchopulmonary aspergillosis (ABPA), bronchiectasis and healthy subjects. Among them, the bronchial asthma group will be divided into asthma control group, asthma partial control group and asthma uncontrolled group according to the GINA asthma control classification. Record the baseline information of the subjects in detail, including basic information, disease course, smoking, previous acute attacks and hospitalizations, long-term medication, etc. (including the frequency, dose and duration of ICS use, antifungal drug type, dose, duration of use, and course of treatment), and evaluate and record environmental factors (such as indoor).Humidity, temperature, ventilation, pet keeping, plant planting, etc.) and other lifestyle factors that may affect disease control and fungal exposure. The patient's disease status was assessed using questionnaire scores.
Sputum samples were taken at the time of enrollment.Set (asthma ABPA group uses sputum induction), pulmonary function test and bronchodilator test, FeNO measurement (asthma ABPA group only), blood routine test, Aspergillus-specific IgE and IgG detection, total immunoglobulin IgE, allergen detection, etc. Dust was collected indoors (bedrooms), outdoor (balconies) and on the surface of air conditioners or fans (if applicable) in the subject's living environment, and environmental data such as ambient temperature, humidity, and particulate matter concentration were recorded. 18S rRNA technology was used for sputum and dust fungus detection, and ELISA was used for asthmatitis symptomatic markers, which assess the impact of fungal infections on the disease. Follow-up for each subject 6 months, 6 months after enrollment, the patient's symptom changes, acute exacerbations/exacerbations, and prognosis were recorded, and relevant questionnaire scores were completed.
- Conditions
- Environmental Exposure, Asthma, Bronchiectasis, ABPA
- Medical subject headings
- Asthma, 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 |
|---|---|---|
| Asthma | Not described | |
| ABPA | Not described | |
| Bronchiectasis | Not described | |
| Healthy control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory fungi
Analysis of sputum samples from patients with bronchial asthma, ABPA, and bronchiectasis using 18sRNA sequencing fungal diversity and abundance in liquid samples.
Measured: Baseline
Secondary outcomes (23)
Environmental fungi
Assess fungal diversity and abundance in the environment, including indoor (bedroom), outdoor (balcony), and air conditioning or fan surfaces (if applicable).
Measured: Baseline
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
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
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
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
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
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, 6-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, 6-month follow-up.
Frequency of Emergency Department Visits
The number of emergency department visits due to acute exacerbations of Asthma, ABPA, 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, 6-month follow-up.
Frequency of Hospitalizations
The number of people hospitalized due to acute exacerbations of Asthma, ABPA, and Bronchiectasis will be recorded, including detailed information such as the length of hospital stay and the treatments administered.
Measured: Baseline, 6-month follow-up.
The use of emergency medication
Including the types of emergency drugs (such as salbutamol), as well as the dosage (number of presses), frequency of use, and duration of use
Measured: Baseline, 6-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,6-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,6-month follow-up.
ICU Admission and Intubation
Records of ICU admissions and whether intubation was required during hospitalization, including associated clinical details.
Measured: Baseline,6-month follow-up.
Systemic Steroid Use
Documentation of systemic corticosteroid use during hospital stays, including dosage and duration.
Measured: Baseline,6-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, 6-month follow-up.
Asthma Control Questionnaire
In the asthma and ABPA research groups, the Asthma Control Questionnaire (ACQ) will be used to evaluate the control of asthma symptoms. ACQ is a validated questionnaire, with each question scoring 0-6 points. The average score will be calculated, with ≤ 0.75 indicating good control, 0.75-1.5 indicating partial control, and>1.5 indicating uncontrolled
Measured: Baseline, 6 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, 6 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, 6 month follow-up.
Borg rating
The Borg score is used to evaluate the degree of respiratory distress in patients with bronchiectasis, measuring their perceived physical activity or intensity using numbers. Subjective fatigue and respiratory distress are quantified on a 0-10 point scale, with higher scores indicating more severe respiratory distress
Measured: Baseline, 6 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, 6 month follow-up.
CAT（COPD Assessment Test） Score
A tool used in the bronchiectasis group to assist in assessing the severity and quality of life of patients with bronchiectasis. The rating range is 0-10 points. Grade classification: 0-2 points: Mild; 3-5 points: moderate; 6-10 points: severe.
Measured: Baseline, 6 month follow-up.
Electronic X Asthma Control Test
In the bronchiectasis group, it is used to assist in evaluating the daily condition of bronchiectasis patients, such as symptoms, sputum volume, and nighttime awakening. The score ranges from 0 to 100, with higher scores indicating poorer disease control.
Measured: Baseline, 6 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 posted2 Jan 2026
- Study start23 Jul 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental ExposureStudies 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
- 125 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
- NCT07313904
- Sponsor's protocol ID
- 2025-155A-01
- Status last verified
- Jul 2025
- First submitted
- 17 Dec 2025
- Last updated
- 2 Jan 2026
- 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Environmental Fungal Exposure on Bronchial Asthma, Allergic Bronchopulmonary Aspergillosis (ABPA), and Bronchiectasis
- ClinicalTrials.gov ID
- NCT07313904
- Acronym / sponsor ID
- 2025-155A-01
- Conditions
- Environmental Exposure, Asthma, Bronchiectasis, ABPA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Ningbo UniversityResearch network
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 Jan 2026 (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 is a prospective, observational study of patients aged 18-80 years with clinical diagnosis of bronchial asthma, allergic bronchopulmonary aspergillosis (ABPA), bronchiectasis and healthy subjects. Among them, the bronchial asthma group will be divided into asthma control group, asthma partial control group and asthma uncontrolled group according to the GINA asthma control classification. Record the baseline information of the subjects in detail, including basic information, disease course, smoking, previous acute attacks and hospitalizations, long-term medication, etc. (including the frequency, dose and duration of ICS use, antifungal drug type, dose, duration of use, and course of treatment), and evaluate and record environmental factors (such as indoor).Humidity, temperature, ventilation, pet keeping, plant planting, etc.) and other lifestyle factors that may affect disease control and fungal exposure. The patient's disease status was assessed using questionnaire scores.
Sputum samples were taken at the time of enrollment.Set (asthma ABPA group uses sputum induction), pulmonary function test and bronchodilator test, FeNO measurement (asthma ABPA group only), blood routine test, Aspergillus-specific IgE and IgG detection, total immunoglobulin IgE, allergen detection, etc. Dust was collected indoors (bedrooms), outdoor (balconies) and on the surface of air conditioners or fans (if applicable) in the subject's living environment, and environmental data such as ambient temperature, humidity, and particulate matter concentration were recorded. 18S rRNA technology was used for sputum and dust fungus detection, and ELISA was used for asthmatitis symptomatic markers, which assess the impact of fungal infections on the disease. Follow-up for each subject 6 months, 6 months after enrollment, the patient's symptom changes, acute exacerbations/exacerbations, and prognosis were recorded, and relevant questionnaire scores were completed.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | – |
| ABPA | – | – |
| Bronchiectasis | – | – |
| Healthy control group | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- No bronchial asthma ABPA、 Healthy individuals aged 18-80 with bronchiectasis or other respiratory diseases
Key inclusion criteria (7 listed)
- Age range of 18-80 years old (including 18 and 80 years old), gender and race are not limited;
- No history of asthma, ABPA, or other chronic respiratory diseases.
- No history of allergic diseases, such as allergic rhinitis, eczema, or food allergies.
- Pulmonary function is normal or close to the normal range.
- Laboratory testing:
Key exclusion criteria (4 listed)
- Suffering from bronchial asthma ABPA、 Bronchiectasis or other respiratory diseases: chronic obstructive pulmonary disease, active pulmonary tuberculosis, pulmonary embolism, lung cancer, pneumothorax, hemoptysis, pulmonary arterial hypertension, interstitial lung disease, etc;
- Cancer patients who suffer from serious other systemic diseases, such as myocardial infarction, stroke, hypertensive crisis or refractory hypertension, severe arrhythmia, heart failure, aortic aneurysm, liver failure, renal failure, hematological disorders, etc., and have recently been discovered or are currently receiving treatment;
- Four weeks prior to enrollment, systemic use of antibiotics, antifungal drugs, immunosuppressants, cytotoxic agents, hormones, etc;
- Other individuals with contraindications for induced sputum testing:
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 fungi
Time frame: Baseline
Analysis of sputum samples from patients with bronchial asthma, ABPA, and bronchiectasis using 18sRNA sequencing fungal diversity and abundance in liquid samples.
23 secondary outcomes
Environmental fungi
Time frame: Baseline
FEV1（Forced Expiratory Volume in 1 second）
Time frame: Baseline
PEF （Peak Expiratory Flow）
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
Number of Acute Exacerbations
Time frame: Baseline, 6-month follow-up.
Severity Grading of Acute Exacerbations
Time frame: Baseline, 6-month follow-up.
Frequency of Emergency Department Visits
Time frame: Baseline, 6-month follow-up.
Frequency of Hospitalizations
Time frame: Baseline, 6-month follow-up.
The use of emergency medication
Time frame: Baseline, 6-month follow-up.
Occurrence of Respiratory Failure
Time frame: Baseline,6-month follow-up.
Use of Non-Invasive Ventilation
Time frame: Baseline,6-month follow-up.
ICU Admission and Intubation
Time frame: Baseline,6-month follow-up.
Systemic Steroid Use
Time frame: Baseline,6-month follow-up.
Length of Hospital Stay
Time frame: Baseline, 6-month follow-up.
Asthma Control Questionnaire
Time frame: Baseline, 6 month follow-up.
AQLQ （Asthma Quality of Life Questionnaire） Score
Time frame: Baseline, 6 month follow-up.
FACED Score
Time frame: Baseline, 6 month follow-up.
Borg rating
Time frame: Baseline, 6 month follow-up.
BEST （Bronchiectasis Evaluation Score for Treatment)）Score
Time frame: Baseline, 6 month follow-up.
CAT（COPD Assessment Test） Score
Time frame: Baseline, 6 month follow-up.
Electronic X Asthma Control Test
Time frame: Baseline, 6 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 2 Jan 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Environmental Exposure and Asthma, run by First Affiliated Hospital of Ningbo University at 1 site in China.
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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 fungi (time frame: Baseline). 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 2 Jan 2026.