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

NCT ID: NCT00888472

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2012-11-30

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.

Conditions

Bronchial Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Leukocytapheresis

Intervention Type: PROCEDURE

5000 ml, the blood volume per body, treated once. Twice at an interval of 6 days.

Interventions

Leukocytapheresis

5000 ml, the blood volume per body, treated once. Twice at an interval of 6 days.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gunma University

OTHER

Sponsor Role: lead

Responsible Party

Tamotsu Ishizuka

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamotsu Ishizuka, M.D.

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Department Medicine and Molecular Science, Gunma University Graduate School of Medicine

Maebashi, Gunma, Japan

Countries

Japan

Other Identifiers

000001936

Identifier Type: -

Identifier Source: org_study_id