Safety and Efficacy of High-dose Leukocytapheresis Using a Large Filter in Refractory Asthma
NCT00888472 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2019-02-15
Summary
Extracorporeal leukocytapheresis (LCAP) or granulocytapheresis (GCAP) has been used in the treatment of patients with rheumatoid arthritis and ulcerative colitis and has shown promising safety and efficacy. LCAP and GCAP seem to be effective for steroid-resistant inflammation. The investigators have already reported safety and efficacy of GCAP in refractory asthma and expect the beneficial effect of LCAP in refractory asthma. In this study, in order to improve the therapeutic effect of LCAP by increasing the quantity of leukocytes that were removed, the investigators conducted a clinical study to investigate safety and efficacy of high-dose LCAP performed using a larger filter and an increased dose of the blood volume per body weight treated, as an possible therapy for refractory asthma.
Conditions
- Bronchial Asthma
Interventions
- PROCEDURE
-
Leukocytapheresis
5000 ml, the blood volume per body, treated once. Twice at an interval of 6 days.
Sponsors & Collaborators
-
Gunma University
lead OTHER
Principal Investigators
-
Tamotsu Ishizuka, M.D. · Assistant Professor
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-11-30
- Primary Completion
- 2012-11-30
- Completion
- 2012-11-30
Countries
- Japan
Study Locations
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