Severe asthma
Conditions
Interventions
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Eligibility Criteria for Asthma Patients in the Static Phenotyping Cohort: (1) Participants must voluntarily participate in this study, abide by study regulations, understand and cooperate with the collection of clinical data, biological samples (peripheral blood, induced sputum, etc.), imaging examinations (chest CT, and chest CT completed within 3 months prior to enrollment is acceptable) and exhaled breath samples, adhere to medication dosages and follow-up schedules, and voluntarily sign the written informed consent form. (2) Participants are aged >= 18 years and = 18 years and <= 80 years with no restrictions on gender or race, and shall sign the written informed consent form voluntarily. (3) Participants have no history of asthma or other chronic respiratory diseases such as COPD and interstitial pneumonia, and present no associated symptoms including wheezing, cough and chest tightness. (4) Pulmonary function tests (FEV1, FEV1/FVC) are within the normal reference range, and the bronchodilator test is negative. (5) The level of fractional exhaled nitric oxide (FeNO) is normal, and routine blood tests including eosinophil count show no abnormalities. (6) Participants have never used asthma-related medications such as ICS, LABA and SABA, or biologic targeted agents in the past. (7) Participants are capable of cooperating with the collection of clinical data, biological samples (peripheral blood), chest CT scan (conducted within 3 months prior to enrollment) and exhaled breath samples. (8) Women of childbearing potential shall adopt effective contraceptive measures during the study period. 3. Eligibility Criteria for Acute Exacerbation Cohort: (1) Participants must voluntarily participate in this study, comply with relevant regulations, and be able to cooperate with clinical data collection, biological sample collection (peripheral blood, sput
Exclusion criteria
Exclusion criteria: 1. Exclusion Criteria for Asthma Patients in the Static Phenotyping Cohort: (1) Subjects who are unable to cooperate with examinations for asthma diagnosis or fail to cooperate for other reasons. (2) Subjects with clinically significant major pulmonary diseases other than asthma (e.g., active pulmonary infection, chronic obstructive pulmonary disease as judged by the investigator, bronchiectasis, pulmonary fibrosis, cystic fibrosis, obesity hypoventilation syndrome, lung cancer, alpha-1 antitrypsin deficiency, primary ciliary dyskinesia), or systemic diseases other than asthma that cause elevated peripheral blood eosinophil counts (e.g., eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome, eosinophilic esophagitis). (3) Subjects with a history of or concomitant autoimmune diseases (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cholangitis, systemic lupus erythematosus, multiple sclerosis). (4) Subjects who developed clinically significant infections requiring systemic antibiotics or antiviral therapy such as upper and lower respiratory tract infections from 4 weeks prior to screening to randomization, or presented with marked abnormalities in routine blood tests excluding eosinophils during the screening period. (5) Subjects with helminthic infection within 6 months prior to screening who have not received standard treatment or failed to respond to standard treatment. (6) Subjects with any history of malignant tumors within 5 years prior to screening, excluding cured malignancies such as basal cell carcinoma, cutaneous squamous cell carcinoma, low-risk or very low-risk localized prostate cancer, papillary thyroid carcinoma, and radically resected carcinoma in situ including ductal carcinoma in situ of the breast and cervical carcinoma in situ. (7) Subjects with severe, progressive or uncontrolled systemic diseases involving the central nervous system, cardiovascular system, digestive system, endocrine system, respiratory system, urinary system, hematological system and other systems, or those deemed ineligible for this clinical trial by the investigator due to potential risks to subject safety or interference with study results. (8) Subjects with a history of chronic alcohol abuse or drug/substance abuse within 1 year prior to screening. (9) Subjects with a history of active tuberculosis within 1 year prior to screening. (10) Subjects who underwent major surgery within 8 weeks prior to screening or plan to receive surgery requiring general anesthesia or hospitalization for more than 1 day during the trial. (11) Subjects who received suplatast tosilate, a T helper 2 (Th2) cytokine inhibitor, within 2 weeks prior to screening. (12) Subjects who received immunoglobulins or blood products within 4 weeks prior to screening. (13) Subjects who received live attenuated vaccines within 4 weeks before the first study drug administration or during the trial period. (14) Asthma patients previously treated with biologic targeted agents, including but not limited to anti-IL-4Ra, anti-IL-5, anti-IL-5Ra, anti-TSLP and anti-IgE monoclonal antibodies. (15) Subjects who received systemic immunosuppressants or immunomodulatory agents such as methotrexate and cyclosporine within 3 months before the first study drug administration, excluding oral corticosteroids (OCS) used for the treatment of asthma or acute asthma exacerbations. (16) Subjects who underwent bronc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized number of acute exacerbations;Induced sputum inflammatory cell count;Forced Expiratory Volume in one second;Peripheral blood eosinophil; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean(First-order Mean);Sputum microbiota abundance;Concentration of exhaled VOCs; | — |
Countries
China
Contacts
Public ContactMin Zhang
Shanghai General Hospital
Outcome results
None listed