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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002980
Receipt No. 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 2019/01/19

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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
Middle name
Last name Betsuyaku Tomoko
Organization Keio University School of Medicine
Division name Division of pulmonary medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Email tbetsuyaku@z5.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Asano
Organization Tokai University School of Medicine
Division name Division of pulmonary medicine
Zip code
Address 143 Shimokasuya, Isehara Kanagawa 259-1193, Japan
TEL 0463-93-1121
Homepage URL
Email ko-asano@tokai-u.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Address
Tel
Email

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
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
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
2019 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.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


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