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

NCT00888472 | Completed

• 1 other identifier: 000001936
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

Extracorporeal leukocytapheresis

Outcome Measures

Primary Outcomes (1)

• Improvement of morning peak flow rate (PEFR) or evening PEFR

  4 weeks after the treatment

Secondary Outcomes (1)

• An improved score of asthma control test

  4 weeks after the treatment

Study Arms (1)

1

EXPERIMENTAL

Procedure: Leukocytapheresis

Interventions

Leukocytapheresis PROCEDURE

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

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients fulfilled the 2001 criteria for refractory asthma in American Thoracic Society.

You may not qualify if:

• Pregnant women.
• Patients with severe cardiovascular diseases.
• Patients with infective diseases.
• Patients with leukocytopenia or anemia.

Sponsors & Collaborators

• Gunma University: lead

Study Sites (1)

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

Maebashi, Gunma, 371-8511, Japan

Location

MeSH Terms

Conditions

Asthma

Interventions

Leukapheresis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Tamotsu Ishizuka, M.D.

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 24, 2009
• First Posted: April 27, 2009
• Study Start: November 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

JP (1)