Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Carbocisteine:Carbocisteine 1500mg/day, PO
Control:Placebo
Sponsors
Guangzhou Institute of Respiratory Disease
Eligibility
Sex/Gender
Male
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Out-patient diagnosed as COPD; A diagnosis of COPD as defined by current ATS/ERS guidelines for the diagnosis and treatment of COPD as follows: Chronic obstructive pulmonary disease is a preventable and treatable disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences; 2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio (FEV1/FVC) less than 0.70 and FEV1 between 25% and 79% of the predicted value; 3. male or female; 4. age of 40 to 80 years old; 5. had a history of at least twice COPD exacerbations within last 2 years; 6. stable for over 4 weeks prior to the study; 7. Well communicated with oral and writing skill; 8. Signed and dated written informed consent obtained from the subject and/or subject's legally acceptable representative prior to study participation.
Exclusion criteria
Exclusion criteria: 1. Allergic or intolerant to carbocisteine; 2. Carbocysteine, N-acetylcystiene used in the past 4 weeks; 3. Acute exacerbation or hospitalization due to COPD 4 weeks prior to run-in; 4. Administration of antibiotics 4 weeks prior to run-in; 5. Need to continuously use systematic corticosteroid; 6. Suffer from bronchiactis, pneumonia, pulmonary fibrosis or active tuberculosis; 7. Previously diagnosed cancer; 8. History of Lung resection surgery (e.g., lung volume reduction surgery, or lobectomy or lung transplant surgery 9. Performed or planning perform respiratory rehabilitation or long term oxygen therapy. 10. Other clinically significant and uncontrolled disorder, including neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes of thyroid disease), cardiovascular, neuromuscular, hepatic, gastric, or hematological abnormalities, or peripheral vascular disease. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation, particularly with regard to exercise challenge procedures, or which would affect the efficacy analysis if the disease/condition exacerbated during the study; 11. Women who are pregnant or lactating or planning pregnancy during the study period; 12. Participated other clinical trials in the past three month; 13. Subject is a study Investigator, sub-Investigator, study coordinator, or employee of a participating Investigator or immediate family members of the aforementioned.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of acute exacerbation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Arterial blood oxygen saturation (SpO2);Lung function change between groups;Health status evaluation by SGRQ score; | — |
Countries
China
Contacts
Public ContactZhong NS
Outcome results
None listed