Safety and Efficacy of High-dose Leukocytapheresis Using a Large Filter in Refractory Asthma
- Conditions
- Bronchial Asthma
- Interventions
- Procedure: Leukocytapheresis
- Registration Number
- NCT00888472
- Lead Sponsor
- Gunma University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- Patients fulfilled the 2001 criteria for refractory asthma in American Thoracic Society.
- Pregnant women.
- Patients with severe cardiovascular diseases.
- Patients with infective diseases.
- Patients with leukocytopenia or anemia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Leukocytapheresis -
- Primary Outcome Measures
Name Time Method Improvement of morning peak flow rate (PEFR) or evening PEFR 4 weeks after the treatment
- Secondary Outcome Measures
Name Time Method An improved score of asthma control test 4 weeks after the treatment
Trial Locations
- Locations (1)
Department Medicine and Molecular Science, Gunma University Graduate School of Medicine
🇯🇵Maebashi, Gunma, Japan