Safety and Efficacy of High-dose Leukocytapheresis Using a Large Filter in Refractory Asthma
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of High-dose Leukocytapheresis Using a Large Filter in Patients With Refractory Asthma|
- Improvement of morning peak flow rate (PEFR) or evening PEFR [ Time Frame: 4 weeks after the treatment ] [ Designated as safety issue: Yes ]
- An improved score of asthma control test [ Time Frame: 4 weeks after the treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
5000 ml, the blood volume per body, treated once. Twice at an interval of 6 days.
|Department Medicine and Molecular Science, Gunma University Graduate School of Medicine|
|Maebashi, Gunma, Japan, 371-8511|
|Principal Investigator:||Tamotsu Ishizuka, M.D.||Assistant Professor|