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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Ningbo University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

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

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

125 Participants
are grouped into 4 trial groups
Group A: Asthma
Group B: ABPA
Group C: Bronchiectasis
Group D: Healthy control group

Trial outcomes

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.

Time frame
Baseline

Secondary outcomes

1

Environmental fungi

Assess fungal diversity and abundance in the environment, including indoor (bedroom), outdoor (balcony), and air conditioning or fan surfaces (if applicable).

Time frame
Baseline
2

FEV1(Forced Expiratory Volume in 1 second)

Pulmonary function FEV1 index was evaluated in liters (L). It refers to the volume of air exhaled in the first second by the subject exhaling at the fastest rate after the maximum inspiration.

Time frame
Baseline
3

PEF (Peak Expiratory Flow)

PEF is measured in liters per minute (L/min). It refers to the maximum flow rate that can be achieved when exhaling at the fastest speed after the maximum inspiration. This indicator can reflect how open the airway is.

Time frame
Baseline
4

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

MMEF75/25 is measured in liters per minute (L/min). This is the average expiratory flow rate over the course of 75% to 25% of the forced expiratory volume. It is primarily used to assess the function of the small airways.

Time frame
Baseline

Other outcomes

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