Chronic Obstructive Pulmonary DiseasePhase 3RESOLUTENCT04053634

Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations

A Phase 3 study testing Benralizumab in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 343 sites in 30 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 40 to 85 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Benralizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 689 participants
Where: 343 sitesin 30 countries
Study dates: 26 Aug 2019to 28 Jul 2025
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of informed consent
Age 40 to 85 years
Male and/or female.
Current or former smoker with a tobacco history of ≥10 pack-years.
History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC<0.70 and FEV1 ≤65% of predicted normal value.
Documented history of 2 or more COPD exacerbations that required treatment with systemic corticosteroids and/or hospitalization within 52 weeks prior to enrollment.

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Exacerbations treated with antibiotics alone are excluded unless accompanied by treatment with systemic corticosteroids and/or hospitalization.
Hospitalization is defined as an inpatient admission ≥24 hours
Previous exacerbations should be confirmed to have occurred while on stable triple therapy for COPD.
At least one qualifying COPD exacerbation should occur while on stable uninterrupted triple therapy prior to enrolment.
Documented use of triple (ICS/LABA/LAMA) background therapy for COPD for ≥3 months immediately prior to enrollment.
Treatment with at least double inhaled therapy containing ICS (e.g. ICS/LABA or ICS/LAMA) for the remaining of 52 weeks prior to enrolment. Use of LABA/LAMA is allowed if ICS cannot be tolerated.
ICS in a dose approved for COPD or equivalent to ≥250 mcg of fluticasone propionate daily.
Total cumulative duration of not being on double or triple background therapy must not exceed 2 months.
Stable therapy/doses for the last 3 months prior to randomization.
Blood eosinophil count ≥300/μL at screening and documented historical eosinophil count of ≥150/μL within 52 weeks of enrollment (or repeated testing during run-in).
CAT total score ≥15 at Visit 1.
Negative pregnancy test for females of childbearing potential (WOCBP) at Visit 1.
Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control from enrollment throughout the study and within 12 weeks after last dose of IP.
Women not of childbearing potential are defined as women who are either permanently sterilized or postmenopausal (confirmed by FSH test for women <50 years).

Who cannot join

Clinically important pulmonary disease other than COPD
Current diagnosis of asthma, prior history of asthma or asthma-COPD overlap according to GINA/GOLD. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18.
Radiological findings of a respiratory disease other than COPD contributing to respiratory symptoms. Solitary pulmonary nodules without appropriate follow up or findings of acute infection.
Another pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
Any unstable disorder that could affect patient safety, study findings or the patient's ability to complete the study.
Any clinically significant abnormal findings in physical examination, vital signs, ECG, laboratory tests could affect patient safety, study findings or the patient's ability to complete the study.

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Cor pulmonale and/or right ventricular failure.
Long-term treatment with oxygen >4.0 L/min and/or oxyhemoglobin saturation <89% while breathing supplemental oxygen.
Use of any non-invasive positive pressure ventilation device (NIPPV). Note: use of CPAP for Sleep Apnea Syndrome is allowed.
Known immunodeficiency disorder, including positive HIV-1/2 testing.
Active liver disease. Chronic stable hepatitis B and C (including positive HBsAg or hepatitis C antibody testing), or other stable chronic liver disease are acceptable.
ALT or AST ≥3 times the upper limit of normal, confirmed by repeated testing during the run-in period.
Helminth parasitic infection within 24 weeks prior to enrollment, not treated or failed to respond to standard of care therapy.
Alcohol or drug abuse within the past year, which may compromise the study data.
Malignancy, current or within the past 5 years, except for adequately treated non invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than 1 year prior to Visit 1. Suspected malignancy or undefined neoplasms.
Evidence of active tuberculosis, as judged by investigator. Patients with a recent (within 2 years) first-time or newly positive PPD or Quantiferon test need to complete an appropriate course of treatment before enrollment. Evaluation will be according to the local standard of care.
Participation, or planned participation, in intensive COPD rehabilitation program (maintenance phase of a rehabilitation is allowed).
History of surgical or endoscopic lung volume reduction within the 6 months prior to enrollment. History of partial or total lung resection (single lobe or segmentectomy is acceptable).
Scheduled major surgical procedure during the study. Minor elective procedures are allowed.
History of anaphylaxis to any biologic therapy or vaccine.
Receipt of blood products or immunoglobulins within 30 days prior to randomization.
Receipt of marketed or investigational biologic product within 4 months or 5 half-lives prior to randomization, whichever is longer. Exception: Patients on stable therapy for 3 months before randomization who intend to stay on treatment throughout the study with marketed biologic products that are not likely to interfere with the safety assessment and/or efficacy of benralizumab, for example, for the treatment of osteoporosis, migraine, pain, diabetes, obesity, ocular, cardiovascular, or metabolic diseases, can participate in the study.
Receipt of live attenuated vaccines 30 days prior to randomization.
Chronic use of immunosuppressive medication or expected need for chronic use during the study.
Chronic use of antibiotics if duration of treatment is <9 months prior to randomization. Chronic macrolide or other antibiotic therapy is allowed provided the patient has been on stable dose/regimen for ≥9 months prior to randomization and has had ≥2 COPD exacerbations while on stable therapy.
Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to enrollment.
Receipt of benralizumab within 12 months prior to enrollment.
Known history of allergy or reaction to any component of the IP formulation.

Trial locations and contacts

343 sites in 30 countries.

Country

City, postcode or hospital

343 sites in 30 countries

United States84 sites

Research Site
Abingdon, Virginia, 24210
Research Site
Amarillo, Texas, 79106
Research Site
Amarillo, Texas, 79124
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Baltimore, Maryland, 21224
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Boston, Massachusetts, 02215
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Buffalo, New York, 14215
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Burlington, North Carolina, 27215
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Charlotte, North Carolina, 28277
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Chattanooga, Tennessee, 37404
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Chicago, Illinois, 60611
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Clearwater, Florida, 33765
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Cleveland, Ohio, 44106
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Columbia, Maryland, 21044
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Columbus, Ohio, 43215
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Cudahy, Wisconsin, 53110
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Cypress, Texas, 77429
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Dallas, Texas, 75390
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Daytona Beach, Florida, 32117
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DuBois, Pennsylvania, 15801
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Edgewater, Florida, 32132
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Elizabeth City, North Carolina, 27909
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Everett, Washington, 98208
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Farmington Hills, Michigan, 48336
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Fort Worth, Texas, 76104
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Franklin, Tennessee, 37067
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Gastonia, North Carolina, 28054
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Georgetown, Kentucky, 40324
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Hendersonville, Tennessee, 37075
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Houston, Texas, 77079
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Iowa City, Iowa, 52242
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Jacksonville, Florida, 32204
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Jacksonville, Florida, 32209
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Johnson City, Tennessee, 37601
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Kansas City, Kansas, 66160
Research Site
Kerrville, Texas, 78028
Research Site
Kissimmee, Florida, 34741
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Kissimmee, Florida, 34746
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Lawrenceville, Georgia, 30046
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Leesburg, Florida, 34748
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Lincoln, Nebraska, 68510
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Little Rock, Arkansas, 72209
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Los Angeles, California, 90033
Research Site
Los Angeles, California, 90048
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Medford, Oregon, 97504
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Miami, Florida, 33125
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Michigan City, Indiana, 46360
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Mooresville, North Carolina, 28117
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Morgantown, West Virginia, 26505
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Mt. Pleasant, South Carolina, 29464
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New Bern, North Carolina, 28562
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New Windsor, New York, 12553
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Newport Beach, California, 92663
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North Charleston, South Carolina, 29406
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North Dartmouth, Massachusetts, 02747
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Northridge, California, 91324
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O'Fallon, Illinois, 62269
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Oklahoma City, Oklahoma, 73106
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Omaha, Nebraska, 68124
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Orlando, Florida, 32819
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Palm Springs, California, 92262
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Pensacola, Florida, 32503
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Peoria, Illinois, 61636
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Philadelphia, Pennsylvania, 19140
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Pittsburgh, Pennsylvania, 15213
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Rapid City, South Dakota, 57702
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Rincon, Georgia, 31326
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Rock Hill, South Carolina, 29732
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Salem, Virginia, 24153
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Salt Lake City, Utah, 84102
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San Antonio, Texas, 78258
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Smithfield, Pennsylvania, 15478
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Spokane, Washington, 99204
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St. Petersburg, Florida, 33707
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Stamford, Connecticut, 06902
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Surprise, Arizona, 85374
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Tampa, Florida, 33607
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The Bronx, New York, 10461
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Tomball, Texas, 77375
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Toms River, New Jersey, 08755
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Westminster, California, 92683
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Williamsburg, Virginia, 23188
Research Site
Wilmington, North Carolina, 28401
Research Site
Winston-Salem, North Carolina, 27103
Research Site
Winter Park, Florida, 32789

Other trials in United States

China31 sites

Research Site
Baotou, 14010
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Beijing, 100034
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Beijing, 102218
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Changsha, 410005
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Changsha, 410015
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Changsha, 430033
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Chengdu, 610041
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Chongqing, 402260
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Ganzhou, 341099
Research Site
Guangzhou, 510180
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Guiyang, 550002
Research Site
Haikou, 570311
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Hebei
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Hefei, 230001
Research Site
Hohhot, 010017
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Hohhot, 10050
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Linhai, 317000
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Nanchang, 330006
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Shanghai, 200002
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Shanghai, 200032
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Shanghai, 200433
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Shenzhen, 518020
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Suzhou, 215000
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Ürümqi, 830054
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Wenzhou, 325027
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Wuhan, 430022
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Wuhan, 430030
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Xi'an, 710061
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Yinchuan, 750001
Research Site
Zhanjiang, 524001
Research Site
Zhengzhou, 450003

Other trials in China

Japan31 sites

Research Site
Chūōku, 103-0022
Research Site
Chūōku, 104-0031
Research Site
Fukuoka, 814-0180
Research Site
Himeji-shi, 672-8064
Research Site
Hitachi-Naka, 312-0057
Research Site
Joyo-shi, 610-0113
Research Site
Kawachinagano-shi, 586-8521
Research Site
Kishiwada-shi, 596-8501
Research Site
Kobe, 650-0047
Research Site
Kōtoku, 136-0075
Research Site
Kure-shi, 737-0023
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Matsusaka-shi, 515-8544
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Mizunami-shi, 509-6134
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Nagaoka-shi, 940-2085
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Nagoya, 457-8511
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Nishinomiya-shi, 663-8501
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Okayama, 700-8558
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Osaka, 531-0073
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Sagamihara-shi, 252-0315
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Sakaide-shi, 762-8550
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Sakaishi, 591-8555
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Seto-shi, 489-8642
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Shinagawa-ku, 140-8522
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Shinagawa-ku, 142-8666
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Toshima-ku, 170-0002
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Toshima-ku, 170-0003
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Toshima-ku, 171-0014
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Toyonaka-shi, 560-8552
Research Site
Ueda-shi, 386-8610
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Yanagawa-shi, 832-0059
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Yokohama, 223-0059

Other trials in Japan

Germany18 sites

Research Site
Bamberg, 96049
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Berlin, 10717
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Berlin, 12157
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Berlin, 13187
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Cologne, 51069
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Darmstadt, 64283
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Hamburg, 20354
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Hanover, D-30173
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Koblenz, 56068
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Leipzig, 04103
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Leipzig, 04207
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Leipzig, 04357
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Marburg, 35037
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Neu-Isenburg, 63263
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Peine, 31224
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Potsdam, 14467
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Rheine, 48431
Research Site
Warendorf, 48231

Other trials in Germany

Canada14 sites

Research Site
Ajax, Ontario, L1S 2J5
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Barrie, Ontario, L4M 6M2
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Calgary, Alberta, T3B 0M3
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Chicoutimi, G7H 5H6
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Montreal, Quebec, H4A 3J1
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Québec, Quebec, G1V 4W2
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Québec, Quebec, G1W 4R4
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Québec, Quebec, G2J 0C4
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Sarnia, Ontario, N7T 4X3
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Saskatoon, Saskatchewan, S7N 0W8
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St. John's, NF, A1A 3R5
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Stouffville, Ontario, L4A 1H2
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Toronto, Ontario, M5T 3A9
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Toronto, Ontario, M9V 4B4

Other trials in Canada

United Kingdom13 sites

Research Site
Barnsley, S75 3DL
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Birmingham, B9 5SS
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Blackpool, FY2 0JH
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Bradford, BD9 6RJ
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Chertsey, KT16 0PZ
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Cottingham, HU16 5JQ
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Leicester, LE3 9QP
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Manchester, M13 9NQ
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Oxford, OX3 7LE
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Perth, PH1 1NX
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Southampton, SO166YD
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Stockton-on-Tees, TS17 6EW
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Wishaw, ML2 0DP

Other trials in United Kingdom

Brazil12 sites

Research Site
Blumenau, 89030-101
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Botucatu, 18.618-686
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Florianópolis, 88036-800
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Maringá, 87015-000
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Porto Alegre, 9002-060
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Porto Alegre, 90020-090
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Porto Alegre, 90610-000
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Porto Alegre, 91350-200
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Santo André, 09080-110
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São Bernardo do Campo, 09750-420
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São Paulo, 05403-000
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Sorocaba, 18040-425

Other trials in Brazil

Hungary12 sites

Research Site
Balassagyarmat, 2660
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Budapest, 1033
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Edelény, 3780
Research Site
Encs, 3860
Research Site
Gödöllő, 2100
Research Site
Hajdúnánás, 4080
Research Site
Komárom, 2900
Research Site
Pécs, 7635
Research Site
Siófok, 8600
Research Site
Százhalombatta, 2440
Research Site
Szeged, 6722
Research Site
Törökbálint, 2045

Other trials in Hungary

Poland12 sites

Research Site
Bialystok, 15-044
Research Site
Chęciny, 26-060
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Grodzisk Mazowiecki, 05-825
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Katowice, 40-648
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Lodz, 90-153
Research Site
Ostrowiec Świętokrzyski, 27-400
Research Site
Poznan, 60-693
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Poznan, 61-578
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Proszowice, 32-100
Research Site
Rzeszów, 35-051
Research Site
Warsaw, 02-793
Research Site
Wieluń, 98-300

Other trials in Poland

Argentina11 sites

Research Site
Buenos Aires, S2000PBJ
Research Site
CABA, C1012AAR
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Ciudad Autónoma de Buenos Aire, C1440BRR
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Ciudad de Buenos Aires, 1425
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Córdoba, X5003DCE
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Florida, B1602DQD
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Mar del Plata, B7600GWV
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Mendoza, M5500CCG
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San Fernando, B1646EBJ
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San Juan Bautista, 1888
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San Miguel de Tucumán, 4000

Other trials in Argentina

Italy8 sites

Research Site
Cona, 44124
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Genoa, 16132
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Milan, 20142
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Milan, 20157
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Naples, 80131
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Reggio Emilia, 42123
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Roma, 00168
Research Site
Rozzano, 20089

Other trials in Italy

Spain8 sites

Research Site
Barcelona, 08017
Research Site
Hospitalet de Llobregat(Barcel, 08907
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Laredo, 39770
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Madrid, 28007
Research Site
Madrid, 28046
Research Site
Madrid, 28850
Research Site
Málaga, 29010
Research Site
Santander, 39008

Other trials in Spain

Chile7 sites

Research Site
Chile, 7770484
Research Site
Curicó, 3341643
Research Site
Quillota, 2260000
Research Site
Santiago, 7500571
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Santiago, 7500698
Research Site
Santiago, 8380453
Research Site
Talca, 3465584

Other trials in Chile

India7 sites

Research Site
Calicut, 673 008
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Coimbatore, 641028
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Guntur, 522001
Research Site
Hyderabad, 500038
Research Site
Jaipur, 302039
Research Site
Thane, 401107
Research Site
Vijayawada, 520 008

Other trials in India

South Korea7 sites

Research Site
Daegu, 42415
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Jeonju, 54907
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Seoul, 03312
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Seoul, 04401
Research Site
Seoul, 05030
Research Site
Seoul, 06591
Research Site
Wŏnju, 26426

Other trials in South Korea

Austria6 sites

Research Site
Bad Ischl, 4820
Research Site
Bludenz, 6700
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Feldbach, A-8330
Research Site
Grieskirchen, 4710
Research Site
Linz, 4020
Research Site
Thalheim, 4600

Other trials in Austria

Colombia6 sites

Research Site
Barranquilla, 80007
Research Site
Cali, 76001000
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Floridablanca, 681004
Research Site
Medellín, 5001000
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Pereira, 660003
Research Site
Zipaquirá, 200251

Other trials in Colombia

Denmark6 sites

Research Site
Aalborg, 9000
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Hvidovre, 2650
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København NV, 2400
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Odense C, 5000
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Roskilde, 4000
Research Site
Vejle, 7100

Other trials in Denmark

Turkey (Türkiye)6 sites

Research Site
Adana, 01330
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Istanbul, 34098
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Istanbul, 34844
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Izmir, 35110
Research Site
Kocaeli, 41380
Research Site
Mersin, 33343

Other trials in Turkey (Türkiye)

Australia5 sites

Research Site
Caringbah, 2229
Research Site
Melbourne, 3004
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South Brisbane, 4101
Research Site
Southport, 4215
Research Site
Spearwood, 6163

Other trials in Australia

Czechia5 sites

Research Site
Brandýs nad Labem, 250 01
Research Site
Jindřichův Hradec, 377 01
Research Site
Ostrava, 708 68
Research Site
Rokycany, 337 22
Research Site
Teplice, 415 01

Other trials in Czechia

Greece5 sites

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Athens, 11527
Research Site
Exohi Thessaloniki, 57010
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Ioannina, 45500
Research Site
Thessaloniki, 56429
Research Site
Thessaloniki, 57010

Other trials in Greece

Mexico5 sites

Research Site
Guadalajara, 44100
Research Site
Guadalajara, 44130
Research Site
Guadalajara, 44200
Research Site
Mérida, 97070
Research Site
Veracruz, 91910

Other trials in Mexico

New Zealand5 sites

Research Site
Auckland, 0626
Research Site
Auckland, 1051
Research Site
Christchurch, 8024
Research Site
Dunedin, 9016
Research Site
Hamilton, 3204

Other trials in New Zealand

Sweden5 sites

Research Site
Göteborg, 413 45
Research Site
Gothenburg, 413 46
Research Site
Lund, 222 22
Research Site
Malmö, 205 02
Research Site
Stockholm, 114 46

Other trials in Sweden

Philippines4 sites

Research Site
Iloilo City, 5000
Research Site
Los Baños, 4030
Research Site
Marilao, 3019
Research Site
Quezon City, 1100

Other trials in Philippines

Bulgaria3 sites

Research Site
Kozloduy, 3320
Research Site
Rousse, 7002
Research Site
Stara Zagora, 6003

Other trials in Bulgaria

Vietnam3 sites

Research Site
Hanoi, 100000
Research Site
Hồ Chí Minh, 700000
Research Site
Ho Chi Minh City, 700000

Other trials in Vietnam

Belgium2 sites

Research Site
Edegem, 2650
Research Site
Erpent, 5101

Other trials in Belgium

Netherlands2 sites

Research Site
Breda, 4818 CK
Research Site
Leeuwarden, 8934 AD

Other trials in Netherlands

About this study

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)

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.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Benralizumab, Placebo
Keywords: Chronic Obstructive Pulmonary Disease, COPD, benralizumab, Fasenra, ICS, inhaled corticosteroids, exacerbations, Lung Disease, LABA/LAMA
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BenralizumabBiological
Benralizumab solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks until the end of treatment.
PlaceboBiological
Matching placebo will be administered subcutaneously with accessorized prefilled syringe (APFS) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks until the end of treatment.

Study groups in NCT04053634
Study group	Role	What they receive
Benralizumab	Experimental	Administrated subcutaneously (SC) every 4 weeks for the first 3 doses, then every 8 weeks Receives: Biological: Benralizumab
Placebo	Placebo comparator	Administrated subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Annualized rate of moderate or severe COPD exacerbations
Moderate or severe COPD exacerbation is defined by symptomatic worsening of COPD requiring:
- Use of systemic corticosteroids for at least 3 days; and/or
- Use of antibiotics; and/or
- An inpatient hospitalization or death due to COPD
Measured: Over first 56 weeks

Secondary outcomes (16)

Annualized rate of severe COPD exacerbations
A severe COPD exacerbation is defined by symptomatic worsening of COPD requiring an inpatient hospitalization or results in death due to COPD
Measured: Minimum of 1 year and an average of 2 years
Annualized rate of COPD exacerbations that are associated with an emergency room/emergency department visit or a hospitalization
Measured: Minimum of 1 year and an average of 2 years
Time to first COPD exacerbation
Measured: During first 56 weeks
Change from baseline in SGRQ total and domain scores
St. George's Respiratory Questionnaire (SGRQ)
Measured: up to 56 weeks
Change from baseline in E-RS:COPD total and domain scores
Evaluating Respiratory Symptoms in COPD (E-RS:COPD)
Measured: up to 56 weeks
Change from baseline in pre-dose/pre-bronchodilator FEV1
FEV1 is the Forced expiratory volume in one second at study site
Measured: up to 56 weeks
All cause and respiratory-related mortality rate
Measured: Minimum of 1 year and an average of 2 years
Annual rate of hospitalizations due to COPD
Measured: Minimum of 1 year and an average of 2 years
Serum benralizumab concentration as a measure of pharmacokinetics
Measured: up to 56 weeks
Anti-drug antibodies (ADA) as a measure of immunogenicity
Measured: up to 56 weeks
Change from baseline in CAT total score
Chronic Obstructive Pulmonary Disease assessment tool (CAT)
Measured: up to 56 weeks
Length of hospital stay
Measured: Minimum of 1 year and an average of 2 years
ICU (Intensive Care Unit) days
Measured: Minimum of 1 year and an average of 2 years
Annual rate of hospitalizations and emergency department visits combined
Measured: Minimum of 1 year and an average of 2 years
Annual rate of unscheduled outpatient visits including unscheduled visits to study sites
Measured: Minimum of 1 year and an average of 2 years
Annual rate of unscheduled healthcare encounters
Measured: Minimum of 1 year and and average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Aug 201928 Jul 2025

First posted12 Aug 2019
Study start26 Aug 2019
Primary completion28 Jul 2025
Study completion28 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 689 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04053634
Sponsor's protocol ID: D3251C00014
Other IDs: 2019-001800-39, 2019
Acronym: RESOLUTE
Status last verified: Aug 2025
First submitted: 16 Jul 2019
Last updated: 19 Aug 2025
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT04053634
Acronym / sponsor ID: RESOLUTE / D3251C00014
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease, COPD, benralizumab, Fasenra, ICS, inhaled corticosteroids, exacerbations, Lung Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 689 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 26 Aug 2019 (actual)
Primary completion: 28 Jul 2025 (actual)
Study completion: 28 Jul 2025 (actual)
First posted: 12 Aug 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Benralizumab	Experimental	Biological: BenralizumabAdministrated subcutaneously (SC) every 4 weeks for the first 3 doses, then every 8 weeks
Placebo	Placebo comparator	Biological: PlaceboAdministrated subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

Provision of informed consent
Age 40 to 85 years
Male and/or female.
Current or former smoker with a tobacco history of ≥10 pack-years.
History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC<0.70 and FEV1 ≤65% of predicted normal value.

Key exclusion criteria (28 listed)

Clinically important pulmonary disease other than COPD
Current diagnosis of asthma, prior history of asthma or asthma-COPD overlap according to GINA/GOLD. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18.
Radiological findings of a respiratory disease other than COPD contributing to respiratory symptoms. Solitary pulmonary nodules without appropriate follow up or findings of acute infection.
Another pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
Any unstable disorder that could affect patient safety, study findings or the patient's ability to complete the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BenralizumabBenralizumab solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks until the end of treatment.	Biological	Benralizumab
PlaceboMatching placebo will be administered subcutaneously with accessorized prefilled syringe (APFS) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks until the end of treatment.	Biological	Placebo

Primary outcome

Annualized rate of moderate or severe COPD exacerbations
Time frame: Over first 56 weeks
Moderate or severe COPD exacerbation is defined by symptomatic worsening of COPD requiring: * Use of systemic corticosteroids for at least 3 days; and/or * Use of antibiotics; and/or * An inpatient hospitalization or death due to COPD

16 secondary outcomes

Annualized rate of severe COPD exacerbations
Time frame: Minimum of 1 year and an average of 2 years
Annualized rate of COPD exacerbations that are associated with an emergency room/emergency department visit or a hospitalization
Time frame: Minimum of 1 year and an average of 2 years
Time to first COPD exacerbation
Time frame: During first 56 weeks
Change from baseline in SGRQ total and domain scores
Time frame: up to 56 weeks
Change from baseline in E-RS:COPD total and domain scores
Time frame: up to 56 weeks
Change from baseline in pre-dose/pre-bronchodilator FEV1
Time frame: up to 56 weeks
All cause and respiratory-related mortality rate
Time frame: Minimum of 1 year and an average of 2 years
Annual rate of hospitalizations due to COPD
Time frame: Minimum of 1 year and an average of 2 years
Serum benralizumab concentration as a measure of pharmacokinetics
Time frame: up to 56 weeks
Anti-drug antibodies (ADA) as a measure of immunogenicity
Time frame: up to 56 weeks
Change from baseline in CAT total score
Time frame: up to 56 weeks
Length of hospital stay
Time frame: Minimum of 1 year and an average of 2 years
ICU (Intensive Care Unit) days
Time frame: Minimum of 1 year and an average of 2 years
Annual rate of hospitalizations and emergency department visits combined
Time frame: Minimum of 1 year and an average of 2 years
Annual rate of unscheduled outpatient visits including unscheduled visits to study sites
Time frame: Minimum of 1 year and an average of 2 years
Annual rate of unscheduled healthcare encounters
Time frame: Minimum of 1 year and and average of 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
This is a poster on the Resolute study.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment.

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gerard Criner, MD principal investigator

Temple University School of Medicine, 3401 North Broad Street, Suite 745 PP, Philadelphia, PA 19140

343 sites in 30 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Benralizumab in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 343 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 343 sites in United States, China, Japan, Germany, Canada and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized rate of moderate or severe COPD exacerbations (time frame: Over first 56 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04053634.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.