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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tamotsu Ishizuka, Gunma University
ClinicalTrials.gov Identifier:
NCT00888472
First received: April 24, 2009
Last updated: February 3, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Bronchial Asthma
 Procedure: Leukocytapheresis

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of High-dose Leukocytapheresis Using a Large Filter in Patients With Refractory Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Gunma University:

Primary Outcome Measures:
  • Improvement of morning peak flow rate (PEFR) or evening PEFR [ Time Frame: 4 weeks after the treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • An improved score of asthma control test [ Time Frame: 4 weeks after the treatment ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: November 2008
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: Leukocytapheresis
5000 ml, the blood volume per body, treated once. Twice at an interval of 6 days.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888472

Locations
Japan
Department Medicine and Molecular Science, Gunma University Graduate School of Medicine
Maebashi, Gunma, Japan, 371-8511
Sponsors and Collaborators
Gunma University
Investigators
Principal Investigator: Tamotsu Ishizuka, M.D. Assistant Professor
  More Information

No publications provided

Responsible Party: Tamotsu Ishizuka, Clinical Professor, Gunma University
ClinicalTrials.gov Identifier: NCT00888472     History of Changes
Other Study ID Numbers: NCT00101626
Study First Received: April 24, 2009
Last Updated: February 3, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Gunma University:
Extracorporeal leukocytapheresis

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013