UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002980 |
|---|---|
| Receipt number | R000003580 |
| Scientific Title | Keio research program for severe asthma in Japanese population |
| Date of disclosure of the study information | 2010/01/25 |
| Last modified on | 2023/01/16 09:38:04 |
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Basic information
Public title
Keio research program for severe asthma in Japanese population
Acronym
Keio-SARP
Scientific Title
Keio research program for severe asthma in Japanese population
Scientific Title:Acronym
Keio-SARP
Region
| Japan |
Condition
Condition
Severe asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Accumulate clinical data and biosamples in Japanese patients with severe asthma in order to establish clinical phenotyping and individualized treatment
Basic objectives2
Others
Basic objectives -Others
Clinical data include exacerbating factor, pulmonary functions, chest images, QOL, responses to the treatments, and biosamples include serum, peripheral blood cells, urine, sputum, exhaled air, exhaled air condensate, and tissue specimens.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical data include exacerbating factor, pulmonary functions, chest images, QOL, responses to the treatments, and biomarkers (cytokines, lipid mediators, cell functions, genetic polymorphisms) in biosamples peripheral blood cells, urine, sputum, exhaled air, exhaled air condensate, and tissue specimens will be determined.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A. Severe asthma group
Satisfy any of 1-5 below
1. Oral steroid use for the treatment of asthma exacerbation during the past one year
2. FEV1 %predicted is below 60% at the stable state
3. Regular oral steroid use >50% of the past one year
4. High dose inhaled corticosteroid
use (600 mcg or more of fluticasone or equivalent)
5. Diagnosed as severe asthma by physician
B. Mild to moderate asthma
None of 1-5 above
Sex and gender are matched with severe asthma group
Key exclusion criteria
1. diffuse lung lesion confirmed by plain chest X-ray film
2. uncontrollable malignancy
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Fukunaga |
Organization
Keio University School of Medicine
Division name
Division of pulmonary medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
kfukunaga@keio.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kabata |
Organization
Keio University School of Medicine
Division name
Division of pulmonary medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
kabata.h@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Funded Research Department of GlaxoSmithKline Asthma COPD Prevention & Treatment in Keio University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
356
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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective case-control sampling
Analyze the association between phenotypes and biomarkers (cytokines, lipid mediators, cell functions, genetic polymorphisms)
Management information
Registered date
| 2010 | Year | 01 | Month | 06 | Day |
Last modified on
| 2023 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003580
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
