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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001147
Receipt No. R000001392
Scientific Title The clinical study for research into genetic factors whether adult patients with asthma can achieve to be clinical remission or not
Date of disclosure of the study information 2008/05/03
Last modified on 2015/01/06

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Basic information
Public title The clinical study for research into genetic factors whether adult patients with asthma can achieve to be clinical remission or not
Acronym The clinical study for research into genetic factors whether adult patients with asthma can achieve to be clinical remission or not
Scientific Title The clinical study for research into genetic factors whether adult patients with asthma can achieve to be clinical remission or not
Scientific Title:Acronym The clinical study for research into genetic factors whether adult patients with asthma can achieve to be clinical remission or not
Region
Japan

Condition
Condition bronchial asthma
Classification by specialty
Pneumology Clinical immunology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 This study purpose is to make clear genetic factors in relation to whether adult patients with asthma can achieve to be clinical remission or not.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes SNPs are related to IFN-g, IL-12R, IL-12, IL-4Ra, IL-13R, LTC4S, FGF-b, MIF, ALOX5, CYP1A2, amount of serum cyyokine such as IL-12, IL-4, IL-13
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 adult patients with asthma achieved clinical remission more than 30 months after withdrawing all therapy or exacerbated after stopping all therapy.
Key exclusion criteria adult patients with asthma without exacerbation less than 30 months after withdrawing all therapy.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naomi Tsurikisawa
Organization National Hospital Organization Sagamihara National Hospital
Division name Clinical Research Center for Allergy and Rheumatology
Zip code
Address 18-1 sakuradai minami-ku sagamihara
TEL 042-742-8311
Email n-tsurikisawa@sagamihara-hosp.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsurikisawa Naomi
Organization National Hospital Organization Sagamihara National Hospital
Division name Clinical Research Center for Allergy and Rheumatology
Zip code
Address 18-1 sakuradai minami-ku sagamihara
TEL 042-742-8311
Homepage URL
Email n-tsurikisawa@sagamihara-hosp.gr.jp

Sponsor
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization Health and Labor Research Grants for Research on Allergic Disease and Immunology from Ministry of Health, Labor, and Welfare of Japan
Organization
Division
Category of Funding Organization
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
2008 Year 05 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
Date of protocol fixation
2006 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 02 Month 01 Day
Last follow-up date
2011 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information It is necessity to distinguish in remission or non-remission state with adult patients with asthma vir clinical examination.

Management information
Registered date
2008 Year 05 Month 03 Day
Last modified on
2015 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001392

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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