UMIN-CTR Clinical Trial

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
Email	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
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	Center for Clinical and Translational Research, Kyushu University
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Tel	+81926425378
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036450