UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020838 |
|---|---|
| Receipt number | 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 | 2023/08/09 19:54:07 |
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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
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
m08702012@gunma-u.ac.jp
Sponsor or person
Institute
Sagamihara National Hospital
Institute
Department
Personal name
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
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
Terminated
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
| 2023 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024019
