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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00888472
First Posted: April 27, 2009
Last Update Posted: February 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tamotsu Ishizuka, Gunma University
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of High-dose Leukocytapheresis Using a Large Filter in Patients With Refractory Asthma

Further study details as provided by Tamotsu Ishizuka, Gunma University:

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Tamotsu Ishizuka, Clinical Professor, Gunma University
ClinicalTrials.gov Identifier: NCT00888472     History of Changes
First Submitted: April 24, 2009
First Posted: April 27, 2009
Last Update Posted: February 5, 2013
Last Verified: February 2013

Keywords provided by Tamotsu Ishizuka, 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