UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001936 |
|---|---|
| Receipt number | 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 12:52:37 |
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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
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
tamotsui@showa.gunma-u.ac.jp
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002356
