Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292877
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2006-02-15
Brief Title:
The Prednisone-sparing Effect of Anti-IL-5 Antibody SB-240563
Sponsor:
St Josephs Healthcare Hamilton
Organization:
St Josephs Healthcare Hamilton
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 its 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 261014 and 18 Doses of prednisone will be reduced in a standard way
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 its 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 261014 and 18 Doses of prednisone will be reduced in a standard way
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SB-240563046 | None | None | None |
| 9427-F2453-21C | None | None | None |