UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002765 |
|---|---|
| Receipt number | R000003360 |
| Scientific Title | Clinical effects of treatment with omalizumab in patients with asthma |
| Date of disclosure of the study information | 2009/11/13 |
| Last modified on | 2011/11/13 23:37:08 |
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Basic information
Public title
Clinical effects of treatment with omalizumab in patients with asthma
Acronym
Clinical effects of treatment with omalizumab in patients with asthma
Scientific Title
Clinical effects of treatment with omalizumab in patients with asthma
Scientific Title:Acronym
Clinical effects of treatment with omalizumab in patients with asthma
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of omalizumab on pulmonary function, induced sputum, chest computed tomography, and quality of life in patients with asthma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indices of chest CT
Key secondary outcomes
Parameters of pulmonary function
Cell counts of induced sputum
Scores of quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Injection omalizumab 75-375mg every 2 or 4 weeks subcutaneously.
Interventions/Control_2
Injection distilled water eveyr 4 weeks subcutaneously.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with asthma symptoms are not controlled well by high-dose of inhaled corticosteroids, and other anti-asthmatic medications
2) Concentration of serum IgE is from 30 to 700 IU/ml and weight from 30 to 150 kg
Key exclusion criteria
1) Patients have hypersensitivity to omalizumab
2) Pregnancy or lactation
3) Patients judged to be inappropriate by doctors
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Hoshino |
Organization
Atami Hospital
International University of Health and Welfare
Division name
Department of Respiratory Medicine
Zip code
Address
13-1 Higashikaigan-cho, Atami
TEL
0557819171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Hoshino |
Organization
Atami Hospital International University of Health and Welfare
Division name
Department of Respiratory Medicine
Zip code
Address
13-1 Higashikaigan-cho, Atami
TEL
0557819171
Homepage URL
Sponsor or person
Institute
Atami Hospital
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 13 | 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
| 2009 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 13 | Day |
Last modified on
| 2011 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003360
