Ignite Creation Date:
2024-05-06 @ 7:32 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02559791
Status:
COMPLETED
Last Update Posted:
2018-04-04
First Post:
2015-09-22
Brief Title:
Anti-Interleukin-5 IL5 Monoclonal Antibody MAb in Prednisone-dependent Eosinophilic Asthma
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Route of Administration of Anti-IL5 Monoclonal Antibody in Prednisone-dependent Eosinophilic Asthma
Status:
COMPLETED
Status Verified Date:
2017-04
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 steroid sparing effect of anti interleukin IL-5 monoclonal antibody has been proven but the effectiveness of subcutaneous SC compared to intravenous IV administration of these drugs to suppress airway eosinophilia is still under debate As part of a previous study 100mg of mepolizumab were administered subcutaneously to a group of subjects with prednisone-dependent eosinophilic asthma Despite this intervention 50 of the subjects 15 patients participated in this study had persistently elevated sputum eosinophil counts The same 15 patients will be invited to participate in the current study and if they provide their informed consent will receive 2 monthly doses of placebo followed by 4 monthly doses of IV reslizumab The primary outcomes are blood and sputum eosinophils and the secondary outcomes include sputum and blood Innate lymphoid cell-2 ILC2 cells cluster of differentiation 4 CD4 cells cluster of differentiation-8 CD8 cells cluster of differentiation-34 CD34 Eosinophil-Basophil cluster cells EoB progenitor cells forced expired volume in 1 second FEV1 asthma control questionnaire ACQ and number of eosinophilic exacerbations Measurements of the outcomes will be done before placebo after placebo and after IV reslizumab This study design will determine whether IV reslizumab is effective in suppressing airway eosinophilia in prednisone-dependent patients
Detailed Description:
Study design
Blinded placebo-controlled sequential clinical trial of 4 monthly doses of intravenously administered reslizumab
The study will include two periods
Period 1 After establishing the minimum dose of prednisone to observe sputum eosinophils 3 and blood eosinophils 300µL all subjects will receive 2 infusions once monthly of matching placebo
Period 2 All subjects will then receive 4 infusions once monthly of reslizumab 3mgkg
Methods
15 patients all of whom had sputum eosinophils 3 and blood eosinophils 300µL who were previously treated with SC100 mg mepolizumab for at least 6 months with the last dose at least 4 months before entering the study will be invited to participate in the study
Since discontinuing mepolizumab these patients would have been re-established on their maintenance dose of daily prednisone high doses of inhaled corticosteroids ICS and long acting beta agonist LABA
Baseline measurements of blood and sputum eosinophils spirometry symptoms ACQ and immune cells in blood and sputum ILC2 cells CD4 cells CD8 cells CD34 EoB progenitor cells will be enumerated by flow cytometry and measures of local autoimmunity using our established protocols at the start of Period 1 baseline measurement
They will then receive 2 infusions of placebo at monthly intervals and measurements will be repeated at the end of Period 1 post-placebo measurement
The subjects will then receive by 4 infusions of 3 mgkg reslizumab at monthly intervals At the end of the 4 months these measurements will be repeated post-reslizumab measurement
Blinded placebo-controlled sequential clinical trial of 4 monthly doses of intravenously administered reslizumab
The study will include two periods
Period 1 After establishing the minimum dose of prednisone to observe sputum eosinophils 3 and blood eosinophils 300µL all subjects will receive 2 infusions once monthly of matching placebo
Period 2 All subjects will then receive 4 infusions once monthly of reslizumab 3mgkg
Methods
15 patients all of whom had sputum eosinophils 3 and blood eosinophils 300µL who were previously treated with SC100 mg mepolizumab for at least 6 months with the last dose at least 4 months before entering the study will be invited to participate in the study
Since discontinuing mepolizumab these patients would have been re-established on their maintenance dose of daily prednisone high doses of inhaled corticosteroids ICS and long acting beta agonist LABA
Baseline measurements of blood and sputum eosinophils spirometry symptoms ACQ and immune cells in blood and sputum ILC2 cells CD4 cells CD8 cells CD34 EoB progenitor cells will be enumerated by flow cytometry and measures of local autoimmunity using our established protocols at the start of Period 1 baseline measurement
They will then receive 2 infusions of placebo at monthly intervals and measurements will be repeated at the end of Period 1 post-placebo measurement
The subjects will then receive by 4 infusions of 3 mgkg reslizumab at monthly intervals At the end of the 4 months these measurements will be repeated post-reslizumab measurement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None