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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000232
Receipt No. R000000234
Scientific Title 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)
Date of disclosure of the study information 2006/12/01
Last modified on 2007/03/20

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Basic information
Public title 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)
Acronym Preventive effect on acute exacerbation of chronic obstructive pulmonary disease with Carbocisteine (PEACE Study)
Scientific Title 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)
Scientific Title:Acronym Preventive effect on acute exacerbation of chronic obstructive pulmonary disease with Carbocisteine (PEACE Study)
Region
Japan

Condition
Condition COPD
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the preventive effect of acute exacerbation in COPD patient (StageII-IV) with Carbocisteine (1500mg/day) for 13 months treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of exacerbations
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Carbocisteine treatment group
1500mg/day (13 months)
Interventions/Control_2 Treatment group without mucolytic agents including Carbocisteine (13 months)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Stable COPD patient (Stage II-IV)
2. Between 40 and 80 years
3. Out-patient
4. Written informed consent
5. At least 2 exacerbations in the previous 2 years
Key exclusion 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
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinosuke Fukuchi
Organization Juntendo University, School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 2-1-1 Hongo, Bunkyo-Ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo University, School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 2-1-1 Hongo, Bunkyo-Ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Department of Respiratory Medicine Juntendo University, School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2006 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2005 Year 04 Month 19 Day
Date of IRB
Anticipated trial start date
2005 Year 06 Month 01 Day
Last follow-up date
2006 Year 10 Month 01 Day
Date of closure to data entry
2006 Year 10 Month 01 Day
Date trial data considered complete
2006 Year 10 Month 01 Day
Date analysis concluded
2006 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 13 Day
Last modified on
2007 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000234

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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