Effects of Environmental Fungal Exposure on Bronchial Asthma, Allergic Bronchopulmonary Aspergillosis (ABPA), and Bronchiectasis
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- First Affiliated Hospital of Ningbo University
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Respiratory fungi
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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:
- •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
- •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:
Outcomes
Primary Outcomes
Respiratory fungi
Time Frame: Baseline
Analysis of sputum samples from patients with bronchial asthma, ABPA, and bronchiectasis using 18sRNA sequencing fungal diversity and abundance in liquid samples.
Secondary Outcomes
- Environmental fungi(Baseline)
- FEV1（Forced Expiratory Volume in 1 second）(Baseline)
- PEF （Peak Expiratory Flow）(Baseline)
- Severity Grading of Acute Exacerbations(Baseline, 6-month follow-up.)
- Asthma Control Questionnaire(Baseline, 6 month follow-up.)
- AQLQ （Asthma Quality of Life Questionnaire） Score(Baseline, 6 month follow-up.)
- MMEF75/25（Maximal Mid-Expiratory Flow between 75% and 25% of FVC）(Baseline)
- Occurrence of Respiratory Failure(Baseline,6-month follow-up.)
- Use of Non-Invasive Ventilation(Baseline,6-month follow-up.)
- FVC （Forced Vital Capacity）(Baseline)
- FEV1/FVC （Forced Expiratory Volume in 1 second to Forced Vital Capacity Ratio）(Baseline)
- Number of Acute Exacerbations(Baseline, 6-month follow-up.)
- Frequency of Emergency Department Visits(Baseline, 6-month follow-up.)
- Frequency of Hospitalizations(Baseline, 6-month follow-up.)
- The use of emergency medication(Baseline, 6-month follow-up.)
- ICU Admission and Intubation(Baseline,6-month follow-up.)
- Systemic Steroid Use(Baseline,6-month follow-up.)
- Length of Hospital Stay(Baseline, 6-month follow-up.)
- FACED Score(Baseline, 6 month follow-up.)
- Borg rating(Baseline, 6 month follow-up.)
- BEST （Bronchiectasis Evaluation Score for Treatment)）Score(Baseline, 6 month follow-up.)
- CAT（COPD Assessment Test） Score(Baseline, 6 month follow-up.)
- Electronic X Asthma Control Test(Baseline, 6 month follow-up.)