UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005700 |
|---|---|
| Receipt number | R000006743 |
| Scientific Title | Studies on the role of respiratory syncytial (RS) virus infection on the development and exacerbations of chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2015/12/01 15:43:27 |
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Basic information
Public title
Studies on the role of respiratory syncytial (RS) virus infection on the development and exacerbations of chronic obstructive pulmonary disease
Acronym
Studies on the role of RS virus infection on the development and exacerbations of chronic obstructive pulmonary disease
Scientific Title
Studies on the role of respiratory syncytial (RS) virus infection on the development and exacerbations of chronic obstructive pulmonary disease
Scientific Title:Acronym
Studies on the role of RS virus infection on the development and exacerbations of chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
respiratory syncytial (RS) virus infection
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to study the role of respiratory syncytial (RS) virus infection on the development and exacerbations of chronic obstructive pulmonary disease
Basic objectives2
Others
Basic objectives -Others
In order to study the relationship between Japanese COPD patients and RS virus infection
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1) The relation between stage of chronic obstructive pulmonary disease (COPD) and antibody titer of RS virus
2) To confirm the increased antibody titer of RS virus in the exacerbations of COPD
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)COPD patients
2)COPD patients at stable condition, and COPD patients with exacerbations or patients who were treated for the exacerbations
3)COPD patients or their families who understand the purposes of the study, and sign an agreement form
Key exclusion criteria
Patients judged inappropriate by physicians
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mutsuo Yamaya |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Advanced Preventive Medicine for Infectious Disease
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
TEL
022-717-7184
myamaya@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mutsuo Yamaya |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Advanced Preventive Medicine for Infectious Disease
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
TEL
022-717-7184
Homepage URL
myamaya@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Advanced Preventive Medicine for Infectious Disease, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Advanced Preventive Medicine for Infectious Disease, Tohoku University Graduate School of Medicine
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
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
東北大学大学院医学系研究科 先進感染症予防学寄附講座
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | 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
| 2011 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 03 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 05 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
1)Antibody titer of RS virus in COPD patients.
2)Antibody titer of RS virus in COPD patients at the exacerbations.
Management information
Registered date
| 2011 | Year | 06 | Month | 01 | Day |
Last modified on
| 2015 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006743
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
