Status:
COMPLETED
The Efficacy and Safety of Arbidol in Reducing the Frequency of AECOPD.
Lead Sponsor:
Shengjing Hospital
Conditions:
COPD Patients
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
Chronic Obstructive Pulmonary Disease (COPD) is currently the fourth leading cause of death in the world. Acute exacerbations of COPD (AECOPD) are the most important events in the course of the diseas...
Eligibility Criteria
Inclusion
- Patients from Outpatient clinic.
- Informed consent and assent must be obtained before any study assessment is performed.
- Aged ≥40 years.
- Continuous respiratory symptoms, such as chronic cough, sputum or shortness of breath etc.
- Exposure to risk factors: Host factors, Tobacco, Occupation, Indoor/outdoor pollution
- FEV1/FVC less than 0.70 after withholding bronchodilator.
- 2 or more acute exacerbations of COPD within the 12 months prior to visit 0. Or more than 1 hospitalizations due to AECOPD within the 12 months prior to visit 0.
- Good compliance.
Exclusion
- Patients with any chronic diseases except COPD which in the opinion of the investigator may interfere with study evaluation or optimal participation in the study.
- Patients with a history of chronic lung disease other than COPD, including (but not limited to) active tuberculosis, lung cancer, clinically significant bronchiectasis, primary pulmonary hypertension, sarcoidosis, interstitial lung disease, asthma (other than asthma COPD overlap), severe cor pulmonale.
- Patients with acute coronary syndrome(ACS) or acute left heart failure within the 6 months prior to visit 0. Patients accepted Coronary interventional therapy or coronary artery bypass grafting due to ACS within the 3 months prior to visit 0.
- Patients with uncontrolled hypertension.
- Patients who started oral \>10mg prednisolone or Equivalent systemic corticosteroids within 4 weeks prior to Visit 1. Or patients who received antibiotics within 4 weeks prior to Visit 1. Or patients who received standard treatment for COPD within 4 weeks prior to Visit 1. Or use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
- Patients who received influenza vaccine or other viral vaccine within the 12 months prior to visit 0.
- The end of AECOPD therapy was within the 4 weeks prior to visit 0. Or Occurrence of AECOPD within the 6 weeks prior to visit 0.
- History of arbidol sensitivity.
- No person directly associated with the administration of the study is allowed to participate as a study subject.
- Use of other investigational intervention within within 30 days.
- Patients with obviously abnormal liver function, AST or ALT\>2 times the upper limit of normal value or total bilirubin\>1.3 times the upper limit of normal value.
Key Trial Info
Start Date :
August 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
351 Patients enrolled
Trial Details
Trial ID
NCT03851991
Start Date
August 30 2019
End Date
October 31 2024
Last Update
July 20 2025
Active Locations (1)
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1
Shenjing Hospital
Shenyang, Liaoning, China, 110004