Bronchial Asthma
Conditions
Keywords
Extracorporeal leukocytapheresis
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.
Interventions
PROCEDURELeukocytapheresis
5000 ml, the blood volume per body, treated once. Twice at an interval of 6 days.
Sponsors
Gunma University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients fulfilled the 2001 criteria for refractory asthma in American Thoracic Society.
Exclusion criteria
* Pregnant women. * Patients with severe cardiovascular diseases. * Patients with infective diseases. * Patients with leukocytopenia or anemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of morning peak flow rate (PEFR) or evening PEFR | 4 weeks after the treatment |
Secondary
| Measure | Time frame |
|---|---|
| An improved score of asthma control test | 4 weeks after the treatment |
Countries
Japan
Outcome results
None listed