Asthma
Conditions
Interventions
Adult group with asthma-like symptoms (Part I):None
Group of preschool children with asthma-like symptoms (Part II):None
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
5 Years to 70 Years
Inclusion criteria
Inclusion criteria: Part I Inclusion Criteria: 1. Research participants must voluntarily participate in this study and abide by the study regulations, understand and comply with and cooperate with the corresponding examinations, comply with the dosage and follow-up plan, and voluntarily sign the written informed consent form. 2. Study participants were > = 18 years old and =8 weeks. 4. The pulmonary function report within 1 year prior to screening showed that the pre-bronchodilator FEV1>=70% predicted value and the post-bronchodilator FEV1/FVC > 0.7. 5. There was no obvious abnormality in the blood routine except for eosinophils, and there was no obvious abnormality in chest CT. 6. Patients who are newly diagnosed with asthma-like symptoms, or patients with a history of suspected asthma in the past but have not used asthma treatment drugs such as inhaled hormones within 1 year. 7. Females of childbearing age take effective contraceptive measures during the trial. Part II Inclusion Criteria: 1. Research participants and their guardians must voluntarily participate in this study and comply with the study regulations, understand and comply with the corresponding examinations, follow the medication dosage and follow-up plan, and voluntarily sign a written informed consent form. 2. Children in the asthma cohort, i.e., children aged >=6 years; 3. Able to complete routine pulmonary function monitoring; 4. Complete clinical data; 5. Not participating in a similar clinical research project after inclusion in the asthma cohort.
Exclusion criteria
Exclusion criteria: Part 1 Exclusion Criteria: 1. Those who cannot cooperate with the relevant examinations of asthma diagnosis or other reasons. 2. Symptoms of respiratory tract infection within 8 weeks. 3. ACE inhibitors, ARBs, ß receptor blockers are in use. 4. History of other types of chronic respiratory diseases such as COPD and interstitial pneumonia; Serious diseases of other systems (e.g., cardiovascular, metabolic, immunological, neurological, urinary, and hematological). 5. History of alcoholism or narcotic drug abuse, or having a history of psychiatric illness, antagonistic personality, adverse motivation, suspiciousness, or other emotional or intellectual problems that may affect the informed validity of participation in this study. 6. Patients who smoke or have quit smoking for less than 6 months; Quit smoking for 6 months, but smoke more than 10 pack-years. 7. Participating in other drug clinical trial projects. Part II Exclusion Criteria: 1. Suffering from other respiratory diseases; 2. Combined with other severe systemic diseases other than the respiratory system, such as severe neurological diseases, congenital heart disease, leukemia, rheumatoid arthritis, etc.; 3. Participated in other similar clinical research projects during the same period or did not agree to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spirometry;Complete blood counts;Exhaled nitric oxide;Bronchodilation test;Bronchial provocation test;VAS cough score;ROC-AUC; | — |
Secondary
| Measure | Time frame |
|---|---|
| ACT score;ACQ score;Chest tightness ACQ-5 score;Net weight sub-index; | — |
Countries
China
Contacts
Public ContactWuping Bao
Shanghai General Hospital
Outcome results
None listed