UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005106 |
|---|---|
| Receipt number | R000006069 |
| Scientific Title | Study to investigate the mechanism of steroid insensitivity in severe asthmatic patients |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2018/03/18 19:22:38 |
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Basic information
Public title
Study to investigate the mechanism of steroid insensitivity in severe asthmatic patients
Acronym
Study to investigate the steroid insensitivity in severe asthma
Scientific Title
Study to investigate the mechanism of steroid insensitivity in severe asthmatic patients
Scientific Title:Acronym
Study to investigate the steroid insensitivity in severe asthma
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To measure levels of biomarkers, which are related to steroid response, in induced sputum of asthmatic patients. To evaluate the relationships between their expression and clinical indices.
Basic objectives2
Others
Basic objectives -Others
Mechanisms which may affect drug responses
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Levels of biomarkers, which are related to steroid insensitiviry, in induced sputum
Key secondary outcomes
1)Expression of asthma related biomarkers in blood
2)Exhaled nitric oxide level
3)Indices of pulmonary function
4)Indices of airway responsiveness
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
1)Adult patients with bronchial asthma who receive outpatient treatment in our clinic
2)Patients who gave consult to the study
3)Healty subjects
Key exclusion criteria
1)Patients with pulmonary infectious diseases, or interstitial pneumonia, or Lung cancer
2)Patients who are considered inappropriate by physicians in charge
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisako Matsumoto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3830
hmatsumo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Tajiri |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3830
Homepage URL
tomokot@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | 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
1)Cross-sectional study in stable asthmatic patients on treatment
2)Longitudinal study in newly referred steroid-naive asthmatic patients
Management information
Registered date
| 2011 | Year | 02 | Month | 18 | Day |
Last modified on
| 2018 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006069
