UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005723 |
|---|---|
| Receipt number | R000006766 |
| Scientific Title | A study of efficacy of humanized anti-human IgE monoclonal antibody, omalizumab for the treatment of severe nonatopic asthma |
| Date of disclosure of the study information | 2011/06/06 |
| Last modified on | 2011/07/18 11:10:22 |
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Basic information
Public title
A study of efficacy of humanized anti-human IgE monoclonal antibody, omalizumab for the treatment of severe nonatopic asthma
Acronym
Omalizumab for severe nonatopic asthma
Scientific Title
A study of efficacy of humanized anti-human IgE monoclonal antibody, omalizumab for the treatment of severe nonatopic asthma
Scientific Title:Acronym
Omalizumab for severe nonatopic asthma
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of anti IgE antibody, omalizumab for the treatment of severe nonatopic asthma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Change in the number of unscheduled hospital visit and systemic corticosteroid rescue for exacerbation of asthma during in 6-month observation and 6-month treatment period
Key secondary outcomes
Change in Asthma Control Test(ACT) score, forced expiratory volume in 1 second, fractional exhaled nitric oxide concentration before and after omalizumab treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with anti-IgE antibody, omalizumab
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Severe nonatopic asthma patients who required sysytemic corticosteroid rescue at least 1 time during 6-momth observation period despite optimal treatment including inhaled corticosteroid
Key exclusion criteria
Patients with active cardiopulmonary diseases other than bronchial asthma or serious medical conditions (e.g. malignancy)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikio Toyoshima |
Organization
Hamamatsu Rosai Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
Shogencho 25, Hamamatsu 430-8525, Japan
TEL
053-462-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikio Toyoshima |
Organization
Hamamatsu Rosai Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
TEL
053-462-1211
Homepage URL
Sponsor or person
Institute
Hamamatsu Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu Rosai Hospital
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
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
| 2011 | Year | 06 | Month | 06 | 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
Completed
Date of protocol fixation
| 2010 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 05 | Day |
Last modified on
| 2011 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006766
