CompletedPhase 4

Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma

Canada10 participantsStarted 2021-02-10

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Asthma confirmed within the past 2 years by:
✓. 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 criteria

✕. 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

What they're measuring

Change in Sputum eosinophilia

Timeframe: At baseline and at the end of each of three dosing periods (every 16 weeks) for total study duration of 48 weeks.

Trial details

NCT IDNCT04710134

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-09

View on ClinicalTrials.gov More Asthma; Eosinophilic trials