UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031934 |
|---|---|
| Receipt number | 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 | 2021/07/27 10:12:16 |
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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 association between virus infection and exacerbations in Japanese patients with COPD and asthmatics
Basic objectives2
Others
Basic objectives -Others
To compare the differences in clinical characteristics, laboratory findings, and outcomes between virus-associated and not virus-associated exacerbations in 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 viruses in COPD and asthmatic exacerbated outpatients
Key secondary outcomes
To compare the differences in clinical characteristics, laboratory findings, and outcomes between virus-associated and not 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 | Koichiro |
| Middle name | |
| Last name | Matsumoto |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Respiratory Medicine
Zip code
8128582
Address
3-1-1 Maidashi, Higashiku, Fukuoka 812-8582, Japan
TEL
092-642-5378
kyushu.u.kokyu@gmail.com
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kan-o |
Organization
Kyushu University Hospital
Division name
Respiratory Medicine
Zip code
8128582
Address
3-1-1 Maidashi, Higashiku, Fukuoka 812-8582, Japan
TEL
092-642-5378
Homepage URL
hanamura@kokyu.med.kyushu-u.ac.jp
Sponsor or person
Institute
Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
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
Center for Clinical and Translational Research, Kyushu University
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Tel
+81926425378
hanamura@kokyu.med.kyushu-u.ac.jp
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）、国立感染症研究所（東京都）
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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
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 National Institute of Infectious Diseases and analyzed by PCR methods. Results of sample analysis and Patients' medical information are collected at Kyusyu University Hospital and evaluated statistically.
Management information
Registered date
| 2018 | Year | 03 | Month | 27 | Day |
Last modified on
| 2021 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036450
| 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 |
