UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002146 |
|---|---|
| Receipt number | R000002622 |
| Scientific Title | Effect of omalizumab on FeNO in patients with severe bronchial asthma |
| Date of disclosure of the study information | 2009/07/01 |
| Last modified on | 2012/06/12 13:34:55 |
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Basic information
Public title
Effect of omalizumab on FeNO in patients with severe bronchial asthma
Acronym
Effect of omalizumab on FeNO
Scientific Title
Effect of omalizumab on FeNO in patients with severe bronchial asthma
Scientific Title:Acronym
Effect of omalizumab on FeNO
Region
| Japan |
Condition
Condition
Severe persistent brochial asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the inhibitory effect of omalizumab on FeNO in patients with severe bronchial asthma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
FeNO
Key secondary outcomes
Score of asthma control test
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with severe allergic asthma whose symptoms are not controlled well by high-dose inhaled glucocorticosteroids and other anti-asthmatic agents.
Key exclusion criteria
Pregnat women and patients whose weight is less than 30kg.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tamotsu Ishizuka |
Organization
Gunma University Graduate School of Medicine
Division name
Departmnet of Medicine and Molecular Science
Zip code
Address
3-39-15 Showa-machi, 371-8511 Japan
TEL
027-220-8123
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tamotsu Ishizuka |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Medicine and Molecular Science
Zip code
Address
TEL
027-220-8123
Homepage URL
Sponsor or person
Institute
Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2009 | Year | 07 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
It is expected that omalizumab may decrese FeNO in patients with severe asthma when it is effective clinically.
Management information
Registered date
| 2009 | Year | 06 | Month | 30 | Day |
Last modified on
| 2012 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002622
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
