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

Официальное название

Effects of Environmental Fungal Exposure on Bronchial Asthma, Allergic Bronchopulmonary Aspergillosis (ABPA), and Bronchiectasis

Обзор

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.

Первичные конечные точки

• Respiratory fungi [Срок оценки: Baseline]

Вторичные конечные точки (12)

• Environmental fungi [Срок оценки: Baseline]
• FEV1（Forced Expiratory Volume in 1 second） [Срок оценки: Baseline]
• PEF （Peak Expiratory Flow） [Срок оценки: Baseline]
• MMEF75/25（Maximal Mid-Expiratory Flow between 75% and 25% of FVC） [Срок оценки: Baseline]
• FVC （Forced Vital Capacity） [Срок оценки: Baseline]
• FEV1/FVC （Forced Expiratory Volume in 1 second to Forced Vital Capacity Ratio） [Срок оценки: Baseline]
• Number of Acute Exacerbations [Срок оценки: Baseline, 6-month follow-up.]
• Severity Grading of Acute Exacerbations [Срок оценки: Baseline, 6-month follow-up.]
• Frequency of Emergency Department Visits [Срок оценки: Baseline, 6-month follow-up.]
• Frequency of Hospitalizations [Срок оценки: Baseline, 6-month follow-up.]
• The use of emergency medication [Срок оценки: Baseline, 6-month follow-up.]
• Occurrence of Respiratory Failure [Срок оценки: Baseline,6-month follow-up.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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:

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Китай · 1 центр

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

Идентификаторы

NCT: NCT07313904 · 2025-155A-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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