UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001147 |
|---|---|
| Receipt number | 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 13:48:08 |
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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
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
n-tsurikisawa@sagamihara-hosp.gr.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
