Chronic obstructive pulmonary, COPD
Conditions
Interventions
Experimental group:Corbrin capsule
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 40-80 years, man or woman; 2. GOLD grade is III-VI;FEV1/FVC is less then 70% and FEV1 is not greater than 50% 20 min afterinhaling albuterol; 3. The patient is in stable stage, that is no actue exacerbation of COPD is experienced in the last 4 weeks; 4. The patient is able to communicate with people verbally or in writing, willing to participate in the study, gives signed informed consent and is able to complete related tests.
Exclusion criteria
Exclusion criteria: 1. Patients who have serious disease other than COPD. Serious disease is defined to be a dease or condition that may be a potential risk for them if they participate the study, affect the study results and reduce their capability of completing the tests, such as serious heart, brain, hepatic, renal and hematology diseases or maglinant tumors; 2. Patients with any of the following abnormal laboratory values: 1) white blood cell counts=12×10^9/L, neutrophile cell rate=80%, hemoglobin=60g/L; 2) AST or ALT is 1.5 times greater than upper limit of normal range, blood creatine is 1.2 times greater than upper limit of normal range or creatinine clearance rate =50ml/min; 3. patients with lung cancer, bronchiectasia, pneumoconiosis or simple restrictive ventilatory dysfunction; 4. patieints with a history of asthma, anaphylactic rhinitis, or blood eosnophils counts =0.6×109/L; 5. patients with active tuberculosis; 6. patients with pulmonary embolism, alpha 1-antitrypsin deficiency or cystic fibrosis; 7. patients have a operation history of phneumonectomy; 8. patients who experience acute exacertaion of COPD within the last four weeks before the first visit, or require hospitalization; 9. patients who receive a study drug within 30 days before the first visit or within six half lives (select the longer one); 10. patients who require systemic (oral or IV) hormonotherapy with unstable doses (dose stable time is less than 6 weeks), hormone dose greater than prednisone 10mg/d or long-term antibiotic therapy(more than 30 days), or nonspecific immunomodulator therapy; 11. Female patients who were pregnant, lactating, or who are of child bearing potential; 12. Patients who are planning to be hospitalized or donate blood; 13. patients who are allergic to the study drug or are not able to tolerate the study drug; 14. Patients with a history of chronic alcoholism, drug abuse or any other facotor causing non-compliance; 15. Patients who participate in other clinical trials at same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Times and severity of acute exacerbation of COPD during treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life (CAT, CCQ);Symptom score (MMRC dyspnea scale);FEV1, FVC, FEV1/FVC;Yearly drop rates of FEV1, FVC, FEV1/FVC;Haematogenic immunity paramaters: proteoglycan 4, C-reaction protein, serum amyloid protein A, calcitonin, matrix metalloproteinases MMP-8, MMP-9, pulmonary surfactant protein D, serum inflammatory factor TNF-a, IL-8, IL-6, IL-2, GM-CSF and so on, PBMC, D-dimer, fibrinogen;Induced sputum: IL-1b, IL-8, IL-6, TNF-a, MPO and cellurity of induced sputum;Urine Leukotrienes B4;Nitric oxide exhaled;The length of time from the first acute exacerbation of COPD;Use of rescue drug;Dropout rate; | — |
Countries
China
Contacts
Public ContactNuofu Zhang
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed