UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005947 |
|---|---|
| Receipt number | R000007026 |
| Scientific Title | Prospective observational Study for the COPD exacerbation |
| Date of disclosure of the study information | 2011/07/07 |
| Last modified on | 2013/10/25 15:31:55 |
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Basic information
Public title
Prospective observational Study for the COPD exacerbation
Acronym
Kyoto COPD cohort study
Scientific Title
Prospective observational Study for the COPD exacerbation
Scientific Title:Acronym
Kyoto COPD cohort study
Region
| Japan |
Condition
Condition
Chronic obstrucive pulmonary disease
Classification by specialty
| Medicine in general | Gastroenterology | Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Prospectively record the exacerbation in COPD patients and examine the associateing factor for COPD exacerbation and the impact of COPD exacerbation on the COPD pathophysiology including co-morbidities.
Basic objectives2
Others
Basic objectives -Others
Record the patients profiles such as pulmonary functions, image analysis, genomic analysis, comorbidities, and patiets-reported outcomes, and prospectively follow the occurence of exacerbation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1 evacerbation frequency
2 image indecies
3 pulmonary functions
4 comorbidities
5 patients-reported outcome
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. definite COPD
Paitents who medical doctors dagonose as suffering from COPD according to GOLD criteria.
2. COPD risk group
Subjects who have histories of tabacco smoke or exposure to ihalation irritants.
Key exclusion criteria
Patiets who suffer from uncontrollable malignancy.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeo Muro |
Organization
Kyoto university
Division name
Respiratory Medicine
Zip code
Address
54Shogoinkawahara-cho, Sakyo-ku, Kyoto
TEL
+81-75-751-3830
smuro@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeo Muro |
Organization
Kyoto university
Division name
Department of Respiratory Medicine
Zip code
Address
54 Shogoinkawahara-cho
TEL
075-751-3830
Homepage URL
smuro@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Deoartment of Respiratory Medicine, Kyoto university
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for scientific research anda grant to the Respiratory Failure Research Group from the Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都大学医学部附属病院 呼吸器内科 関連施設
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort
randam sample
Management information
Registered date
| 2011 | Year | 07 | Month | 07 | Day |
Last modified on
| 2013 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007026
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
