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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)
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.
Age
40 - 85 years
Sex
ALL
Healthy Volunteers
No
Research Site
Surprise, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Newport Beach, California, United States
Research Site
Northridge, California, United States
Research Site
Palm Springs, California, United States
Research Site
Westminster, California, United States
Research Site
Stamford, Connecticut, United States
Research Site
Clearwater, Florida, United States
Start Date
August 26, 2019
Primary Completion Date
July 28, 2025
Completion Date
July 28, 2025
Last Updated
August 19, 2025
689
ACTUAL participants
Benralizumab
BIOLOGICAL
Placebo
BIOLOGICAL
Lead Sponsor
AstraZeneca
NCT07477600
NCT05878769
NCT06717659
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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