The Prednisone-sparing Effect of Anti-IL-5 Antibody (SB-240563)
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- The prednisone-sparing effect of SB-240563 versus placebo as
- indicated by the absolute and percentage dose reduction possible without a clinical exacerbation (as measured by the Juniper ACQ in patients with asthma or by Likert symptom scores +/- FEV1 in patients with eosinophilic bronchitis without asthma).
- The prednisone-sparing effect of SB-240563 or placebo as indicated
- by the absolute and percentage dose reduction possible without a clinical
- exacerbation as measured by
- a.% sputum eosinophils, b. FEV1 % predicted and methacholine PC20., c. Blood eosinophils, d. Amount of rescue salbutamol use., e. Time to exacerbation.
|Study Start Date:||January 2005|
|Study Completion Date:||July 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
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. The investigators 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.
|Firestone Institute for Respiratory Health, St. Joseph's Healthcare Hamilton|
|Hamilton, Ontario, Canada, L8N 4A6|
|Principal Investigator:||Frederick E Hargreave, MD||McMaster University|