Safety and Efficacy of High-dose Leukocytapheresis Using a Large Filter in Refractory Asthma

Gunma University

Status: Completed

Conditions: Bronchial Asthma

Treatments: Procedure: Leukocytapheresis

Study type: Interventional

Funder types: Other

Identifiers

NCT00888472

000001936

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

1

Experimental group

Treatment:

Procedure: Leukocytapheresis