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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002765
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Atami Hospital
International University of Health and Welfare
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003360

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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