A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE) (RESOLUTE)
Phase 3 study to evaluate the efficacy and safety of a benralizumab in patients with moderate
to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral
blood eosinophils (≥300/μL).
Eligible patients must have a history of ≥2 moderate and/or severe COPD exacerbations in the
previous year despite receiving triple (ICS/LABA/LAMA) background therapy for at least 3
months and ICS-based dual inhaled treatment for the remainder of the year. Eligible patients
must also have an elevated blood eosinophil count.
The treatment period will be of variable duration and will continue until the last patient
has the opportunity to complete a minimum of 56 weeks, at which point all patients will
complete the study. The primary endpoint will be analyzed at Week 56.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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