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NCT Number: NCT00888472

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Maebashi, Gunma, 371-8511, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Leukocytapheresis

Procedure

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

Primary outcomes

  1. Improvement of morning peak flow rate (PEFR) or evening PEFR

    Time frame: 4 weeks after the treatment

Secondary outcomes

  1. An improved score of asthma control test

    Time frame: 4 weeks after the treatment

Sponsors and collaborators

Lead sponsor

Gunma University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 27, 2009
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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