Anti-Interleukin-5 (IL5) Monoclonal Antibody (MAb) in Prednisone-dependent Eosinophilic Asthma
Canada10 participantsStarted 2015-10
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Informed consent Prior to the beginning of the study, patients must be willing and fully capable to provide written informed consent.
✓. Prednisone-dependent eosinophilic asthma
✓. Previous treatment with 100 mg mepolizumab administered subcutaneously for at least 6 months, with the last dose at least 4 months before entering the study
✓. Sputum eosinophils ≥3% and blood eosinophil ≥300/µL on visit 1 (screening visit).
✓. Age between 18 and 75 years.
✓. Male or eligible female subjects:
✓. Male subjects who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of study drug and for 3 months after the last dose of study drug.
Exclusion criteria
✕. Currently receiving another monoclonal antibody
✕. Currently receiving other investigational drug or immunosuppressive medication
What they're measuring
1
Sputum eosinophil percentage
Timeframe: Measured before the placebo phase (week 2), after 2 infusions of placebo (week 10), and after 4 infusions (week 26) of reslizumab 3mg/kg
2
Blood eosinophil absolute number
Timeframe: Measured before the placebo phase (week 2), after 2 infusions of placebo (week 10), and after 4 infusions/4 months (week 26) of reslizumab 3mg/kg
✕. Known hypersensitivity to Reslizumab product or any of its excipients.
✕. Intolerance, hypersensitivity, insensitivity or neutralizing antibody to mepolizumab.
✕. Malignancy within the last 2 years
✕. Any co-morbidity that the investigator believes is a contraindication. This includes but is not limited to any respiratory (eg. COPD, pulmonary fibrosis, EGPA, ABPA), cardiovascular, gastrointestinal, hematological, neurological, immunological, musculoskeletal, renal, infectious, neoplastic or inflammatory condition that may place the safety of the subject at risk during the duration of the study, influence the results of the study or their interpretation, or prevent the patient from completing the entire duration of the study.
✕. Current pregnancy or lactation
✕. Current smoker or ex-smoker with a smoking history greater than 20 pack years.