Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT05594303
Eligibility Criteria:
Inclusion Criteria:
* Subjects aged between 40 to 75;
* Subjects diagnosed with COPD and meet the following standards: a. sustained airway obstruction; b. post-bronchodilator FEV1\<80% predicted value;
* Subjects with DLCO\<80% predicted value in spirometry;
* Subjects with a smoking history more than 10 pack-years (current smoker and former smoker);
* Subjects with stable condition for more than 4 weeks;
* Subjects tolerant to bronchoscopy;
* Subjects signed informed consent.
Exclusion Criteria:
* Pregnant or lactating women;
* Subjects with syphilis or any of HIV, HBV, HCV positive antibody;
* Subjects with any malignancy;
* Subjects requiring anti-infection (bacteria or virus) treatment by intravenous drugs;
* Subjects suffering from any of the following pulmonary diseases: asthma, active tuberculosis, pulmonary embolism, pneumothorax, pulmonary artery hypertension caused by other diseases;
* Subjects with a history of invasive or non-invasive mechanical ventilation in the past 4 weeks;
* Subjects suffering from other serious diseases, such as diabetes, myocardial infarction, unstable angina, cirrhosis, and acute glomerulonephritis;
* Subjects with leukopenia (WBC less than 4x10\^9 / L) or agranulocytosis (WBC less than 1.5x10\^9 / L or neutrophils less than 0.5x10\^9 / L) caused by any reason;
* Subjects with severe renal impairment, serum creatinine\> 1.5 times of the upper limit of normal;
* Subjects with liver disease or liver damage: ALT, AST, total bilirubin\> 2 times of the upper limit of normal;
* Subjects with a history of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders;
* Subjects with severe arrhythmias (such as ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter, etc.) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG;
* Subjects with a history of alcohol or illicit drug abuse;
* Subjects allergic to products from cattle and pig;
* Subjects accepted by any other clinical trials within 3 months before the enrollment;
* Subjects with poor compliance, difficult to complete the study;
* Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT05594303
Study Brief:
Protocol Section:
NCT05594303