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

NCT07313904 | Recruiting

• 1 other identifier: 2025-155A-01
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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. 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

Asthma; Bronchiectasis; ABPA; Environmental Exposure

Outcome Measures

Primary Outcomes (1)

• Respiratory fungi

  Analysis of sputum samples from patients with bronchial asthma, ABPA, and bronchiectasis using 18sRNA sequencing fungal diversity and abundance in liquid samples.

  Baseline

Secondary Outcomes (23)

• Environmental fungi

  Baseline

• FEV1（Forced Expiratory Volume in 1 second）

  Baseline

• PEF （Peak Expiratory Flow）

  Baseline

• MMEF75/25（Maximal Mid-Expiratory Flow between 75% and 25% of FVC）

  Baseline

• FVC （Forced Vital Capacity）

  Baseline

Study Arms (4)

Asthma

ABPA

Bronchiectasis

Healthy control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

No bronchial asthma ABPA、 Healthy individuals aged 18-80 with bronchiectasis or other respiratory diseases

You may qualify if:

• 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:
• \. 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• First Affiliated Hospital of Ningbo University: lead

Study Sites (1)

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

Ningbo, Zhejiang, 315010, China

RECRUITING

MeSH Terms

Conditions

Asthma; Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Chao Cao

CONTACT

+86-0574-87089878; caocdoctor@163.com

Shiyi He

CONTACT

+86-0574-87089878; shiyihii@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 2, 2026
• Study Start: July 23, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)