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

Bronchial Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888472
• Other study ID #: 000001936
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: November 2012

Study information

• Verified date: February 2019
• Source: Gunma University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

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

Locations

Country	Name	City	State
Japan	Department Medicine and Molecular Science, Gunma University Graduate School of Medicine	Maebashi	Gunma

Sponsors (1)

Lead Sponsor	Collaborator
Gunma University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of morning peak flow rate (PEFR) or evening PEFR		4 weeks after the treatment
Secondary	An improved score of asthma control test		4 weeks after the treatment