Effects of Environmental Fungal Exposure on Bronchial Asthma, ABPA and Bronchiectasis
Recruiting · NCT07313904 · Observational (researchers observe without assigning treatment) · Lead sponsor: First Affiliated Hospital of Ningbo University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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:
Where it is running
1 location listed.
- The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang Recruiting - Ningbo, Zhejiang, China