NCT07313904 Effects of Environmental Fungal Exposure on Bronchial Asthma, ABPA and Bronchiectasis
| NCT ID | NCT07313904 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Ningbo University |
| Condition | Environmental Exposure |
| Study Type | OBSERVATIONAL |
| Enrollment | 125 participants |
| Start Date | 2025-07-23 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 125 participants in total. It began in 2025-07-23 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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:
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07313904 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Environmental Exposure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07313904 currently recruiting?
Yes, NCT07313904 is actively recruiting participants. Contact the research team at caocdoctor@163.com for enrollment information.
Where is the NCT07313904 trial being conducted?
This trial is being conducted at Ningbo, China.
Who is sponsoring the NCT07313904 clinical trial?
NCT07313904 is sponsored by First Affiliated Hospital of Ningbo University. The trial plans to enroll 125 participants.