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Sponsors and Collaborators: |
St. Joseph's Healthcare GlaxoSmithKline |
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Information provided by: | St. Joseph's Healthcare |
ClinicalTrials.gov Identifier: | NCT00292877 |
The purpose of this study is to determine if treatment with anti-IL-5 antibody has a prednisone-sparing effect in patients with symptomatic eosinophilic bronchitis (with or without asthma).
Condition | Intervention | Phase |
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Asthma |
Drug: SB-240563 (Mepolizumab) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effects of a Humanized Anti-IL-5 Monoclonal Antibody (SB-240563) on Asthma Control, Airway Eosinophilia and the Degree to Which Corticosteroid Treatment Can be Reduced to Maintain Control |
Estimated Enrollment: | 20 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | July 2007 |
Eosinophilic bronchitis, which is identified by quantitative sputum cell counts (eosinophils greater than 2%) is responsive to corticosteroid treatment.
It occurs alone or in association with asthma or in some patients with chronic obstructive pulmonary disease (COPD). In most patients the eosinophilic bronchitis responds to treatment with inhaled steroids but in some it requires a minimum dose of prednisone to keep it controlled. At present, there is no outstanding drug which can have a prednisone-sparing effect.
Interleukin (IL)-5 is a cytokine specifically focused on the development, differentiation, recruitment, activation and survival of the eosinophil. The specificity of IL-5 has raised the possibility that blocking it's activity, using humanized monoclonal antibodies, may be useful therapy for eosinophilic bronchitis. Such an antibody (SB-240563) has been introduced for clinical trial. We will compare its effect versus placebo in patients with prednisone-dependant symptomatic eosinophilic bronchitis (with or without asthma) before and after a reduction in prednisone dose to identify if it has a prednisone-sparing effect.
The study is divided into 3 sequential study periods. Period 1: symptomatic eosinophilic bronchitis (with or without asthma) on the same dose of prednisone for 6-weeks or more. Period 2: standardized prednisone reduction (and inhaled steroid if prednisone is discontinued during the study treatment) at intervals of 4-weeks until there is a clinical and eosinophilic exacerbation or bothersome steroid withdrawl effects. Period 3: washout. The patients will be seen every 2 weeks. Intravenous injections of SB-240563 750mg or placebo will be given at weeks 2,6,10,14 and 18. Doses of prednisone will be reduced in a standard way.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Firestone Institute for Respiratory Health, St. Joseph's Healthcare Hamilton | |
Hamilton, Ontario, Canada, L8N 4A6 |
Principal Investigator: | Frederick E Hargreave, MD | McMaster University |
Study ID Numbers: | RP#02-2115, SB-240563/046, 9427-F2453-21C |
Study First Received: | February 15, 2006 |
Last Updated: | April 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00292877 History of Changes |
Health Authority: | Canada: Health Canada |
1. Eosinophilic bronchitis, 2. Asthma, 3. Steroid dependent asthma, 4. Sputum eosinophils, 5. SB-240563 (Mepolizumab) |
Prednisone Bronchial Diseases Benzocaine Asthma Eosinophilia Antibodies, Monoclonal Lung Diseases, Obstructive Hypersensitivity |
Antibodies Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Bronchitis Immunoglobulins Respiratory Hypersensitivity |
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |