Anti-Interleukin-5 (IL5) Monoclonal Antibody (MAb) in Prednisone-dependent Eosinophilic Asthma
Status:
Completed
Trial end date:
2017-08-01
Target enrollment:
Participant gender:
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 (Eo/B 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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
McMaster University
Collaborators:
St. Joseph's Healthcare Hamilton Teva Pharmaceuticals USA