Chronic obstructive pulmonary disease
Conditions
Interventions
Arbidol group:Abidol 200 mg orally three times a day
control group:Take placebo three times a day
Sponsors
Shengjing Hospital
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients from Outpatient clinic 2. Informed consent and assent must be obtained before any study assessment is performed; 3. Aged = 40 years; 4. Continuous respiratory symptoms, such as chronic cough, sputum or shortness of breath etc.; 5. Exposure to risk factors: Host factors, Tobacco, Occupation, Indoor/outdoor pollution; 6. FEV1/FVC less than 0.70 after withholding bronchodilator; 7. 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; 8. Good compliance.
Exclusion criteria
Exclusion criteria: 1. 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; 2. 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; 3. 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; 4. Patients with uncontrolled hypertension; 5. 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; 6. Patients who received influenza vaccine or other viral vaccine within the 12 months prior to visit 0; 7. 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; 8. History of arbidol sensitivity; 9. No person directly associated with the administration of the study is allowed to participate as a study subject; 10. 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; 11. bilirubin>1.3 times the upper limit of normal value.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of moderate or severe acute exacerbation in patients with chronic obstructive pulmonary disease; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of hospitalization due to acute exacerbation of chronic obstructive pulmonary disease;The time between the first use of the study drug and the next acute exacerbation (days);Average duration of moderate to severe acute exacerbation of chronic obstructive pulmonary disease;Utilization of medical care resources (the number of unplanned outpatient visits for COPD, the number of rescues for COPD being sent to the emergency room, the number of hospitalizations for COPD aggravating, and the number of intubation rescues for COPD aggravating);The decrease of FEV1 in COPD patients after one year, i.e. the value of Delta FEV1 compared with baseline;Respiratory viral composition in patients with acute exacerbation of chronic obstructive pulmonary disease requiring hospitalization; | — |
Countries
China
Contacts
Public ContactLi Zhao
Shengjing Hospital
Outcome results
None listed