Bronchial asthma
Conditions
Interventions
Gold Standard:The screening period meets any one of the following objective checks for variable airflow limitation: 1. Positive bronchodilation test
2. Positive bronchial provocation test
3. Positive bronchodilation test after 1 month of anti-asthma treatment.
Index test:Combining medical big data, including demographic information, symptom questionnaires, pulmonary function tests, blood tests, FENO, and imaging data.
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Informed Consent: The subject has fully understood the purpose, nature, and methodology of the trial, voluntarily agrees to participate as a subject, and has signed the Informed Consent Form (ICF) prior to the initiation of any study procedures. 2. Adults aged 18 to 65 years (inclusive). Patients must be newly diagnosed with mild bronchial asthma in a non-acute exacerbation phase, in accordance with the latest domestic Guidelines for the Prevention and Treatment of Bronchial Asthma and the 2023 Chinese Expert Consensus on the Diagnosis and Treatment of Mild Bronchial Asthma. 3. During the screening period, the subject must meet at least one of the following objective criteria for variable airflow limitation: Positive bronchodilator reversibility test; Positive bronchial provocation test; Positive bronchodilator reversibility test after 1 month of anti-asthma treatment; 4. Baseline pulmonary function test showing FEV1 % predicted >= 70%. 5. The subject or their legal guardian is capable of communicating effectively with the investigator and is able to understand and comply with all requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity or intolerance to budesonide, formoterol, salbutamol, or any component of the study medication. 2. Subjects who have had respiratory tract infections, sinus infections, or otitis media within the past 2 months; 3. Subjects who are unable to cooperate with the relevant examinations for asthma diagnosis or are unable to cooperate for other reasons; 4. Subjects with a history of Chronic Obstructive Pulmonary Disease (COPD), interstitial lung disease, restrictive lung disease, tuberculosis, cystic fibrosis, bronchiectasis, or alpha-1 antitrypsin deficiency. Subjects with major concomitant diseases are also excluded; 5. Subjects currently using ACE inhibitors (ACEIs), Angiotensin II Receptor Blockers (ARBs), or beta-blockers (including eye drops); subjects who have received oral corticosteroids or systemic steroid therapy; or subjects who have used leukotriene receptor antagonists (e.g., zafirlukast, pranlukast, montelukast, etc.); 6. Current smokers or subjects who have quit smoking for less than 6 months. Subjects who quit smoking more than 6 months ago but have a smoking history exceeding 10 pack-years are also excluded; 7. Subjects with known or suspected alcohol and/or drug abuse; or those with a history of mental illness, antagonistic personality, poor motivation, suspiciousness, or other emotional or intellectual issues that may affect the validity of informed consent for this study; 8. Subjects with abnormal and clinically significant results in vital signs, physical examination, 12-lead ECG, chest CT, complete blood count (CBC), urinalysis, blood biochemistry, or coagulation function; 9. Female subjects who are pregnant (positive pregnancy test) or lactating; 10. Patients who are unable to comply with the study procedures or, in the opinion of the investigator, are not suitable to participate in the trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC;specificity,;precision; | — |
Countries
China
Contacts
Public ContactXue Zhang
Shanghai General Hospital
Outcome results
None listed