Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations
Public ClinicalTrials.gov record NCT04053634. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04053634
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 689 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 25, 2019
- Primary completion
- Jul 27, 2025
- Completion
- Jul 27, 2025
- Last update posted
- Aug 18, 2025
2019 – 2025
United States locations
- U.S. sites
- 84
- U.S. states
- 31
- U.S. cities
- 80
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Surprise | Arizona | 85374 | — |
| Research Site | Little Rock | Arkansas | 72209 | — |
| Research Site | Los Angeles | California | 90033 | — |
| Research Site | Los Angeles | California | 90048 | — |
| Research Site | Newport Beach | California | 92663 | — |
| Research Site | Northridge | California | 91324 | — |
| Research Site | Palm Springs | California | 92262 | — |
| Research Site | Westminster | California | 92683 | — |
| Research Site | Stamford | Connecticut | 06902 | — |
| Research Site | Clearwater | Florida | 33765 | — |
| Research Site | Daytona Beach | Florida | 32117 | — |
| Research Site | Edgewater | Florida | 32132 | — |
| Research Site | Jacksonville | Florida | 32204 | — |
| Research Site | Jacksonville | Florida | 32209 | — |
| Research Site | Kissimmee | Florida | 34741 | — |
| Research Site | Kissimmee | Florida | 34746 | — |
| Research Site | Leesburg | Florida | 34748 | — |
| Research Site | Miami | Florida | 33125 | — |
| Research Site | Orlando | Florida | 32819 | — |
| Research Site | Pensacola | Florida | 32503 | — |
| Research Site | St. Petersburg | Florida | 33707 | — |
| Research Site | Tampa | Florida | 33607 | — |
| Research Site | Winter Park | Florida | 32789 | — |
| Research Site | Lawrenceville | Georgia | 30046 | — |
| Research Site | Rincon | Georgia | 31326 | — |
| Research Site | Chicago | Illinois | 60611 | — |
| Research Site | O'Fallon | Illinois | 62269 | — |
| Research Site | Peoria | Illinois | 61636 | — |
| Research Site | Michigan City | Indiana | 46360 | — |
| Research Site | Iowa City | Iowa | 52242 | — |
| Research Site | Kansas City | Kansas | 66160 | — |
| Research Site | Georgetown | Kentucky | 40324 | — |
| Research Site | Baltimore | Maryland | 21224 | — |
| Research Site | Columbia | Maryland | 21044 | — |
| Research Site | Boston | Massachusetts | 02215 | — |
| Research Site | North Dartmouth | Massachusetts | 02747 | — |
| Research Site | Farmington Hills | Michigan | 48336 | — |
| Research Site | Lincoln | Nebraska | 68510 | — |
| Research Site | Omaha | Nebraska | 68124 | — |
| Research Site | Toms River | New Jersey | 08755 | — |
| Research Site | Buffalo | New York | 14215 | — |
| Research Site | New Windsor | New York | 12553 | — |
| Research Site | The Bronx | New York | 10461 | — |
| Research Site | Burlington | North Carolina | 27215 | — |
| Research Site | Charlotte | North Carolina | 28277 | — |
| Research Site | Elizabeth City | North Carolina | 27909 | — |
| Research Site | Gastonia | North Carolina | 28054 | — |
| Research Site | Mooresville | North Carolina | 28117 | — |
| Research Site | New Bern | North Carolina | 28562 | — |
| Research Site | Wilmington | North Carolina | 28401 | — |
| Research Site | Winston-Salem | North Carolina | 27103 | — |
| Research Site | Cleveland | Ohio | 44106 | — |
| Research Site | Columbus | Ohio | 43215 | — |
| Research Site | Oklahoma City | Oklahoma | 73106 | — |
| Research Site | Medford | Oregon | 97504 | — |
| Research Site | DuBois | Pennsylvania | 15801 | — |
| Research Site | Philadelphia | Pennsylvania | 19140 | — |
| Research Site | Pittsburgh | Pennsylvania | 15213 | — |
| Research Site | Smithfield | Pennsylvania | 15478 | — |
| Research Site | Mt. Pleasant | South Carolina | 29464 | — |
| Research Site | North Charleston | South Carolina | 29406 | — |
| Research Site | Rock Hill | South Carolina | 29732 | — |
| Research Site | Rapid City | South Dakota | 57702 | — |
| Research Site | Chattanooga | Tennessee | 37404 | — |
| Research Site | Franklin | Tennessee | 37067 | — |
| Research Site | Hendersonville | Tennessee | 37075 | — |
| Research Site | Johnson City | Tennessee | 37601 | — |
| Research Site | Amarillo | Texas | 79106 | — |
| Research Site | Amarillo | Texas | 79124 | — |
| Research Site | Cypress | Texas | 77429 | — |
| Research Site | Dallas | Texas | 75390 | — |
| Research Site | Fort Worth | Texas | 76104 | — |
| Research Site | Houston | Texas | 77079 | — |
| Research Site | Kerrville | Texas | 78028 | — |
| Research Site | San Antonio | Texas | 78258 | — |
| Research Site | Tomball | Texas | 77375 | — |
| Research Site | Salt Lake City | Utah | 84102 | — |
| Research Site | Abingdon | Virginia | 24210 | — |
| Research Site | Salem | Virginia | 24153 | — |
| Research Site | Williamsburg | Virginia | 23188 | — |
| Research Site | Everett | Washington | 98208 | — |
| Research Site | Spokane | Washington | 99204 | — |
| Research Site | Morgantown | West Virginia | 26505 | — |
| Research Site | Cudahy | Wisconsin | 53110 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 259 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04053634, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 18, 2025 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04053634 live on ClinicalTrials.gov.