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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005700
Receipt No. 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

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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
Email 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
Email myamaya@med.tohoku.ac.jp

Sponsor
Institute Department of Advanced Preventive Medicine for Infectious Disease, Tohoku University Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.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


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