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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) (PROTOCOL # D3251C00014)

Study Details
Brief Summary:

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. 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.

Learn More

ClinicalTrials.gov NCT number
NCT04053634
Principal Investigator(s)
Paul Sachs, MD

Principal Investigators

  • Paul Sachs, MD
Sponsor(s)
AstraZeneca
Contact
Hospitalist at 203-358-8879
or Officeofresearch@stamhealth.org

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