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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020838
Receipt No. R000024019
Scientific Title The analysis of viral genomes in patients with exacerbated aspirin-exacerbated respiratory disease (AERD)
Date of disclosure of the study information 2016/02/02
Last modified on 2020/02/04

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Basic information
Public title The analysis of viral genomes in patients with exacerbated aspirin-exacerbated respiratory disease (AERD)
Acronym The analysis of viral genomes in patients with exacerbated AERD
Scientific Title The analysis of viral genomes in patients with exacerbated aspirin-exacerbated respiratory disease (AERD)
Scientific Title:Acronym The analysis of viral genomes in patients with exacerbated AERD
Region
Japan

Condition
Condition Aspirin-exacerbated respiratory disease (AERD)
Classification by specialty
Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To cyclopaedically analyze the viruses relevant to exacerbated AERD
Basic objectives2 Others
Basic objectives -Others diagnosis of pathologic conditions
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Differences in viruses participating in exacerbation between AERD and non-AERD
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients diagnosed with AERD or non-AERD by a systemic aspirin provocation test within the last fifteen years
2) Patients requiring consultation without reservation due to asthma exacerbation
3) Patients having cold symptom within 5 days of the consultation
Key exclusion criteria Patients considered unsuitable by the attending physician
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Masami
Middle name
Last name Taniguchi
Organization Sagamihara National Hospital
Division name Clinical Research Center for Allergy and Rheumatology
Zip code 252-0392
Address 18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
TEL 042-742-8311
Email m-taniguchi@sagamihara-hosp.gr.jp

Public contact
Name of contact person
1st name Yosuke
Middle name
Last name Kamide
Organization Sagamihara National Hospital
Division name Clinical Research Center for Allergy and Rheumatology
Zip code 252-0392
Address 18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
TEL 042-742-8311
Homepage URL
Email m08702012@gunma-u.ac.jp

Sponsor
Institute Sagamihara National Hospital
Institute
Department

Funding Source
Organization Labour Sciences Research Grant
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Sagamihara National Hospital
Address 18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
Tel 042-742-8311
Email sugawara.rumi.rz@mail.hosp.go.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

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 02 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
2015 Year 12 Month 01 Day
Date of IRB
2015 Year 12 Month 03 Day
Anticipated trial start date
2016 Year 02 Month 02 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 Study design: case-control study
Study duration:from 2016/2/2 to 2020/3/31
Subjects:All subjects that our hospital visited by broncholial asthma, and met the selection criteria.
Analyzing items: background factor (age, sex, coexisting disease, etc), subjective and objective symptom, viral genomes in the blood, lung function test, blood examination (hematological value, CRP, AST, ALT, BUN, Cre), sputum culture.

Management information
Registered date
2016 Year 02 Month 01 Day
Last modified on
2020 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024019

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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