UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006448 |
|---|---|
| Receipt number | R000007655 |
| Scientific Title | Characteristics of Japanese asthmatics with severe exacerbation, -Nationwide, multicenter, prospective study- |
| Date of disclosure of the study information | 2011/10/03 |
| Last modified on | 2013/01/09 10:00:53 |
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Basic information
Public title
Characteristics of Japanese asthmatics with severe exacerbation, -Nationwide, multicenter, prospective study-
Acronym
Characteristics of Japanese asthmatics with severe exacerbation
Scientific Title
Characteristics of Japanese asthmatics with severe exacerbation, -Nationwide, multicenter, prospective study-
Scientific Title:Acronym
Characteristics of Japanese asthmatics with severe exacerbation
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the characteristics of patients with severe asthma attacks, such as backgrounds, risk factors, circumstances, triggers, symptoms and signs.
To explore the characteristics related to time to maintain the SpO2 level of >90% for 24 hours after admission, hospitalization period, time to wean from oxygen, and occurrence of near fatal asthma.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to maintain the SpO2 level of >90% for 24 hours after admission
Key secondary outcomes
- Hospitalization period
- Time to wean form oxygen therapy
- Occurrence of near-fatal asthma
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Patients requiring hospitalization due to severe asthma attacks
- Patients with SpO2 of =< 90% on room air at the time of hospitalization or transportation before treatment
Key exclusion criteria
- Patients requiring hospitalization due to any reason other than asthma attacks
- Patients ruled out by investigators due to ineligibilities
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tanaka |
Organization
Sapporo Medical University
Division name
3rd Dept.of Internal Medicine, School of Medicine
Zip code
Address
S1W16, Chuo-ku, Sapporo
TEL
011-611-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaru Fujii |
Organization
Sapporo Medical University
Division name
3rd Dept.of Internal Medicine, School of Medicine
Zip code
Address
S1W16, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
mafuji@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Foundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Translational Research Informatics Center, Foundation for Biomedical Research and Innovation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
札幌医科大学附属病院
藤沢市民病院
国立病院機構相模原病院
東海大学医学部附属病院
トヨタ記念病院
JA愛知厚生連 豊田厚生病院
大津赤十字病院
神戸市立医療センター 中央市民病院
大阪府済生会中津病院
国立病院機構福岡病院
置賜広域病院組合 公立置賜総合病院
亀田総合病院
横浜市立大学附属市民総合医療センター
国立国際医療研究センター病院
富岡地域医療事務組合公立富岡総合病院
医療法人豊田会 刈谷豊田総合病院
静岡県立総合病院
兵庫県立尼崎病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 03 | 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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
A prospective observational study of
identifying the characteristics of patients with severe asthma attacks, as well as exploring the characteristics related to time to maintain the SpO2 level of >90% for 24 hours after admission, hospitalization period, time to wean from oxygen, and occurrence of near fatal asthma
Management information
Registered date
| 2011 | Year | 09 | Month | 30 | Day |
Last modified on
| 2013 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007655
| 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 |
