UMIN ID: C000000232
Registered date:01/12/2006
A randomized, 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 | 150 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Carbocisteine treatment group 1500mg/day (13 months) Treatment group without mucolytic agents including Carbocisteine (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 | Department of Respiratory Medicine Juntendo University, School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | 2-1-1 Hongo, Bunkyo-Ku, Tokyo Japan |
| Telephone | |
| Affiliation | Juntendo University, School of Medicine Department of Respiratory Medicine |
| scientific contact | |
| Name | Yoshinosuke Fukuchi |
| Address | 2-1-1 Hongo, Bunkyo-Ku, Tokyo Japan |
| Telephone | |
| Affiliation | Juntendo University, School of Medicine Department of Respiratory Medicine |