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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031934
Receipt No. R000036450
Scientific Title Surveying Adults and Children with Virus-associated Exacerbation of Respiratory Diseases
Date of disclosure of the study information 2018/04/01
Last modified on 2018/04/10

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Basic information
Public title Surveying Adults and Children with Virus-associated Exacerbation of Respiratory Diseases
Acronym SAVER study
Scientific Title Surveying Adults and Children with Virus-associated Exacerbation of Respiratory Diseases
Scientific Title:Acronym SAVER study
Region
Japan

Condition
Condition chronic obstructive pulmonary disease
bronchial asthma
Classification by specialty
Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the epidemiology of hMPV-associated exacerbations in Japanese patients with COPD and asthmatics
Basic objectives2 Others
Basic objectives -Others To determine clinical features of hMPV-associated exacerbations in Japanese patients with COPD and asthmatics
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To investigate the detection rate and seasonal variations of hMPV in COPD and asthmatic exacerbated outpatients
Key secondary outcomes To compare clinical features such as symptoms, blood cells and lung function between hMPV-associated and other respiratory virus-associated exacerbations

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
6 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Exacerbated adult outpatients (20 y old and older) with suspected respiratory virus infection who was diagnosed with COPD, asthma or asthma-COPD overlap
2. Exacerbated pediatric outpatients (6-16 y old) with suspected respiratory virus infection who was diagnosed with asthma
Key exclusion criteria Patients with pneumoniae, interstitial pneumonia and acute heart failure
Target sample size 690

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Nakanishi
Organization Graduate School of Medical Sciences, Kyushu University
Division name Respiratory Medicine
Zip code
Address 3-1-1 Maidashi, Higashiku, Fukuoka 812-8582, Japan
TEL 092-642-5378
Email kyushu.u.kokyu@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Kan-o
Organization Kyushu University Hospital
Division name Respiratory Medicine
Zip code
Address 3-1-1 Maidashi, Higashiku, Fukuoka 812-8582, Japan
TEL 092-642-5378
Homepage URL http://www.kokyu.med.kyushu-u.ac.jp
Email hanamura@kokyu.med.kyushu-u.ac.jp

Sponsor
Institute Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization Japanese Society of Allergology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 九州大学病院(福岡)、国立病院機構福岡病院(福岡)、国立病院機構福岡東医療センター(福岡)、国立病院機構大牟田病院(福岡)、福岡大学病院(福岡)

Other administrative information
Date of disclosure of the study information
2018 Year 04 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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 04 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 Nasopharyngeal swab samples and medical information are collected from patients in Fukuoka Hospital, Fukuoka Higashi Medical Centre and Omuta Hospital. Samples are sent to Fukuoka University Hospital and analyzed by real-time PCR. Results of sample analysis and Patients' medical information are collected to Kyusyu University Hospital and evaluated statistically.

Management information
Registered date
2018 Year 03 Month 27 Day
Last modified on
2018 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036450

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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