UMIN ID: C000000233
Registered date:01/12/2006
A randomized, placebo controlled, parallel-group, multicenter clinical trial to evaluate the preventive effect on acute exacerbation of chronic obstructive pulmonary disease (COPD) with Carbocisteine (1500mg/day)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | COPD |
| Date of first enrollment | 2005/06/01 |
| Target sample size | 720 |
| Countries of recruitment | Asia(except Japan) |
| Study type | Interventional |
| Intervention(s) | Carbocisteine group 1500mg/day (13 months) Placebo group (13 months) |
Outcome(s)
| Primary Outcome | Frequency of exacerbations |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 40years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Intolerance for Carbocisteine 2. Use of mucolytic agents within one month prior to beginning of the study 3. Use of antibiotics at the beginning of the study 4. Bronchiectasis, pneumonia, interstitial lung disease, tuberculosis 5. Carcinoma 6. Previous lung transplant or lung volume reduction surgery 7. Pregnant or breastfeeding 8. Attendance in the other study within 3 months prior to the beginning of the study 9. Underlying severe disease |
Related Information
| Primary Sponsor | Kyorin Pharmaceutical Co., LTD |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Kyorin Pharmaceutical Co., LTD |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | 5, Kanda Surugadai, 2-Chome Chiyoda-ku, Tokyo Japan |
| Telephone | |
| Affiliation | Kyorin Pharmaceutical Co., LTD P. L. C. Management Dept. |
| scientific contact | |
| Name | Nan-Shan Zhong |
| Address | 151 Yanjiang Rd, Guangzhou, China Japan |
| Telephone | |
| Affiliation | Guangzhou Institute of Respiratory Diseases Director |