Dose escalation of reslizumab can ameliorate sputum eosinophilia in severe asthmatics who have persistent sputum eosinophilia despite treatment with reslizumab at the standard dose.
Monoclonal antibody therapies targeting the interleukin-5 (IL-5) pathway, critical for maintaining eosinophil homeostasis, have been developed as adjunct therapy for severe asthma with an eosinophilic phenotype. Reslizumab/Cinqair is an approved/marketed product administered monthly by intravenous to severe eosinophilic asthmatics at 3mg/kg. However some patients do exhibit sputum eosinophilia at this dosage. We are investigating whether those that receive 3mg/kg that have persistent sputum eosinophils would benefit at a higher dose of 4mg/kg and those that still exhibit sputum eosinophils at this elevated dose would show improvement at 5mg/kg. The overall aim of this study is to determine whether dose escalation of reslizumab can ameliorate sputum eosinophilia in severe asthmatics who have persistent sputum eosinophilia despite treatment with reslizumab at the standard dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Reslizumab 3,4, or 5 mg/kg IV q4 weeks
Firestone Institute of Respiratory Health, St Joseph's Hospital
Hamilton, Ontario, Canada
Change in Sputum eosinophilia
Absolute difference between the mean sputum eosinophil percent
Time frame: At baseline and at the end of each of three dosing periods (every 16 weeks) for total study duration of 48 weeks.
Change in Proportion of patients with sputum eosinophils ≤3%
Number of patients with sputum eosinophils ≤3%
Time frame: At the start and end of each of three dosing periods (every 16 weeks) for total study duration of 48 weeks
Change in Blood eosinophil count
Absolute blood eosinophil count
Time frame: At the start and end of each of three dosing periods (every 16 weeks) for total study duration of 48 weeks
Change in ACQ5 score
Mean of 5-question Asthma Control Questionnaire
Time frame: At the start and end of each of three dosing periods (every 16 weeks) for total study duration of 48 weeks
Change in FEV1
Forced expired volume in 1 second measured in litres
Time frame: At the start and end of each of three dosing periods (every 16 weeks) for total study duration of 48 weeks
Change in Number of asthma exacerbations
Number of asthma event that are defined as exacerbation (requiring increase in corticosteroids)
Time frame: At the start and end of each of three dosing periods (every 16 weeks) for total study duration of 48 weeks
Change in Type of asthma exacerbations (as determined by quantitative sputum cytometry)
Type of exacerbation shown by: neutrophilic, eosinophilic or mixed neutrophilic/eosinophilic bronchitis
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Time frame: At the start and end of each of three dosing periods (every 16 weeks) for total study duration of 48 weeks
Change in Proportion of patients requiring daily oral corticosteroid therapy
Number of patients that require daily oral corticosteroids
Time frame: At the start and end of each of three dosing periods (every 16 weeks) for total study duration of 48 weeks
Change in Cumulative systemic corticosteroid dose
The total daily dose of oral corticosteroids
Time frame: At the start and end of each of three dosing periods (every 16 weeks) for total study duration of 48 weeks