A Phase 4 interventional study of Reslizumab in Asthma; Eosinophilic, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-25.
Sponsored by McMaster University · Phase 4, Interventional, and Treatment
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.
3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 10 is below the median of 83 across 2,751 interventional studies indexed under Asthma.
Browse Asthma studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Asthma confirmed within the past 2 years by:
a. A ≥12% improvement in forced expiratory volume in 1 second (FEV1) after use of a beta agonist, or a methacholine challenge test showing a ≥20% reduction in FEV1 after a concentration of ≤8 mg/mL of methacholine
Exclusion Criteria:
All patients will initially receive reslizumab 3 mg/kg for at least 16 weeks.
Biological: Reslizumab
Patients who have uncontrolled sputum eosinophilia at 16 weeks will receive an increased dose of 4 mg/kg for the next 16 weeks. The patients with controlled eosinophilia will continue to receive 3 mg/kg.
Biological: Reslizumab
Patients who have uncontrolled sputum eosinophilia who were previously receiving reslizumab at 4 mg/kg at 32 weeks will receive an increased dose of 5 mg/kg for the next 16 weeks. The patients remaining patients will continue on the dose they were receiving (i.e., either 3 mg/kg or 4 mg/kg).
Biological: Reslizumab
Reslizumab 3,4, or 5 mg/kg IV q4 weeks
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
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
Plan to share: No
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