Effects of Environmental Fungal Exposure on Bronchial Asthma, ABPA and Bronchiectasis

NCT ID: NCT07313904

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-23

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Environmental Exposure Asthma Bronchiectasis ABPA

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Asthma

No interventions assigned to this group

ABPA

No interventions assigned to this group

Bronchiectasis

No interventions assigned to this group

Healthy control group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Age range of 18-80 years old (including 18 and 80 years old), gender and race are not limited;
2. No history of asthma, ABPA, or other chronic respiratory diseases.
3. No history of allergic diseases, such as allergic rhinitis, eczema, or food allergies.
4. Pulmonary function is normal or close to the normal range.
5. 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.

Exclusion Criteria

1. 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;
2. 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;
3. Four weeks prior to enrollment, systemic use of antibiotics, antifungal drugs, immunosuppressants, cytotoxic agents, hormones, etc;
4. Other individuals with contraindications for induced sputum testing:
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital of Ningbo University

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang Recruiting

Ningbo, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chao Cao

Role: CONTACT

+86-0574-87089878

Shiyi He

Role: CONTACT

+86-0574-87089878

Facility Contacts

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Chao CAO

Role: primary

+86-0574-87089878

Shiyi He

Role: backup

+86-0574-87089878

Other Identifiers

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2025-155A-01

Identifier Type: -

Identifier Source: org_study_id

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