Status:
COMPLETED
Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Teva Canada
Conditions:
Asthma; Eosinophilic
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Dose escalation of reslizumab can ameliorate sputum eosinophilia in severe asthmatics who have persistent sputum eosinophilia despite treatment with reslizumab at the standard dose.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- Blood eosinophils ≥400 cells/µL and/or sputum eosinophils ≥3% (or presence of moderate-to-many free eosinophil granules) at the time of study enrollment
- Treated with an inhaled corticosteroid at a dose of ≥1500 µg of fluticasone propionate (or equivalent) and a long-acting beta agonist with or without oral corticosteroids
- Ability to provide informed consent
Exclusion
- Current smokers, ex-smokers with greater than 20 pack-year history or ex-smokers who have smoked within the past 6 months
- Any comorbidity that the investigator believes is a contraindication including but not limited to any respiratory (e.g., chronic obstructive pulmonary disease, allergic bronchopulmonary aspergillosis, pulmonary fibrosis), cardiovascular (e.g., congestive cardiac failure, pulmonary hypertension), hematological, gastrointestinal, immunological, musculoskeletal, infectious, or neoplastic disease
- Currently treated with another biologic agent (excluding denosumab for osteoporosis)
- Use of anti-IL-5 (other than reslizumab) or anti-IgE mAb use within the past one month
- Use of a systemic immunosuppressive or immunomodulatory agent within 6 months prior to study entry
- Suspected of abusing drugs or alcohol
- Pregnancy or lactation
Key Trial Info
Start Date :
February 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04710134
Start Date
February 10 2021
End Date
January 9 2024
Last Update
January 25 2024
Active Locations (1)
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1
Firestone Institute of Respiratory Health, St Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6