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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001936
Receipt No. R000002356
Scientific Title Safety and efficacy of high-dose leukocytapheresis using a large filter in patients with refractory asthma
Date of disclosure of the study information 2009/05/02
Last modified on 2013/01/31

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Basic information
Public title Safety and efficacy of high-dose leukocytapheresis using a large filter in patients with refractory asthma
Acronym Safety and efficacy of high-dose leukocytapheresis using a large filter in refractory asthma
Scientific Title Safety and efficacy of high-dose leukocytapheresis using a large filter in patients with refractory asthma
Scientific Title:Acronym Safety and efficacy of high-dose leukocytapheresis using a large filter in refractory asthma
Region
Japan

Condition
Condition Refractory asthma
Classification by specialty
Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to investigate the efficacy of leukocytapheresis in refractory asthma.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Improvement of the peak flow rate in morning and evening.
Key secondary outcomes Improvement of the scores in asthma control tests.

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
Device,equipment
Interventions/Control_1 High-dose leukocyapheresis using a large filter is performed once a week and twice totally.
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
18 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients fulfilled the 2001 criteria for refractory asthma in American Thoracic Society
Key exclusion criteria Pregnant women.
Patients with severe cardiovascular diseases.
Patients with infective diseases.
Patients with leukocytopenia or anemia.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tamotsu Ishizuka
Organization Gunma University Graduate Schoo of Medicine
Division name Department of Medicine and Molecular Science
Zip code
Address 3-39-15 Showa-machi, Maebashi 371-8511, Japan
TEL 027-220-8123
Email

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 3-39-15 Showa-machi, Maebashi 371-8511, Japan
TEL 027-220-8123
Homepage URL
Email tamotsui@showa.gunma-u.ac.jp

Sponsor
Institute Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine
Institute
Department

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
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00888472
Org. issuing International ID_1 ClinicalTrials.gov
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 05 Month 02 Day

Related information
URL releasing protocol
Publication of results Partially 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
2008 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2012 Year 11 Month 30 Day
Date of closure to data entry
2012 Year 11 Month 30 Day
Date trial data considered complete
2012 Year 11 Month 30 Day
Date analysis concluded
2013 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2009 Year 05 Month 02 Day
Last modified on
2013 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002356

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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