Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History
NCT ID: NCT02155660
Last Updated: 2019-06-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2255 participants
INTERVENTIONAL
2014-06-25
2018-04-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History
NCT02138916
Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations
NCT04053634
A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01227278
Immunological Basis for Benralizumab Activity in Chronic Obstructive Pulmonary Disease (COPD)
NCT05273359
Tezepelumab COPD Exacerbation Study
NCT04039113
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Benralizumab Arm A
Benralizumab administered subcutaneously
Benralizumab Arm A
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Benralizumab Arm B
Benralizumab administered subcutaneously
Benralizumab Arm B
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Benralizumab Arm C
Benralizumab administered subcutaneously
Benralizumab Arm C
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Placebo
Placebo administered subcutaneously
Placebo
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Benralizumab Arm A
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Benralizumab Arm B
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Benralizumab Arm C
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Placebo
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects 40-85 y.o.
* Moderate to very severe COPD with Post Bronchodilator (BD) FEV1\>20% and ≤65%.
-≥2 moderate or ≥1 severe COPD exacerbation(s) required treatment or hospitalization within 2-52 weeks prior to Visit1.
* Modified Medical Research Council (mMRC) score ≥1 at Visit 1.
* Treatment with double or triple therapy throughout the year prior to Visit 1, constant 2 weeks prior to Visit 1.
* Tobacco history of ≥10 pack-years.
* Women of childbearing potential must use a highly effective form of birth control from Visit 1 until 16 weeks after their last dose, and negative serum pregnancy test result at Visit 1.
* Male subjects who are sexually active must be surgically sterile one year prior to Visit 1 or use an adequate method of contraception from the first Investigational Product (IP) dose until 16 weeks after their last dose.
* Compliance with maintenance therapy during run-in ≥70%.
* Blood eosinophils due to subject's stratification and cap for blood eosinophil levels.When any eosinophil cohort is full, subjects in the completed cohort will not be randomised and will be withdrawn from the study.
Exclusion Criteria
* Any disorder or major physical impairment that is not stable by Investigator opinion and/or could affect: - subject safety-study findings or their interpretation or subject's ability to complete the entire study duration.
* Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that in Investigator's judgment may put the patient at risk or negatively affect the study outcome.
* Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 2 weeks prior to Visit1 or during the enrolment and run-in period.
* Acute upper or lower respiratory infection requiring antibiotics within 2 weeks prior to Visit1 or during the enrolment and run-in period.
* Pneumonia within 8 weeks prior to Visit1 or during the enrolment and run-in period.
* Pregnant, breastfeeding, or lactating women.
* Risk factors for pneumonia
* History of anaphylaxis to any other biologic therapy.
* Long term oxygen therapy with signs and/or symptoms of cor pulmonale, right ventricular failure.
* Use of immunosuppressive medication within 2 weeks prior to Visit1 and/or during the enrolment and run-in period.
* Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1.
* Evidence of active tuberculosis (TB) without an appropriate course of treatment.
* Lung volume reduction surgery within the 6 months prior to Visit 1. History of partial or total lung resection (single lobe or segmentectomy is acceptable).
* Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
* Previous treatment with benralizumab.
* Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.
40 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MedImmune LLC
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bartolome R. Celli, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital, Pulmonary Division, 75 Francis Street, PBB Clinics 3, Boston, MA 02115
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Birmingham, Alabama, United States
Research Site
Gulf Shores, Alabama, United States
Research Site
Montgomery, Alabama, United States
Research Site
Flagstaff, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Anaheim, California, United States
Research Site
Arcadia, California, United States
Research Site
Bakersfield, California, United States
Research Site
Fresno, California, United States
Research Site
Fullerton, California, United States
Research Site
Hawaiian Gardens, California, United States
Research Site
Huntington Beach, California, United States
Research Site
Los Angeles, California, United States
Research Site
Northridge, California, United States
Research Site
Palmdale, California, United States
Research Site
Peninsula, California, United States
Research Site
Placentia, California, United States
Research Site
Rolling Hills Estates, California, United States
Research Site
Westminster, California, United States
Research Site
Centennial, Colorado, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Denver, Colorado, United States
Research Site
Chiefland, Florida, United States
Research Site
Clearwater, Florida, United States
Research Site
Clearwater, Florida, United States
Research Site
Coconut Creek, Florida, United States
Research Site
Coral Gables, Florida, United States
Research Site
Daytona Beach, Florida, United States
Research Site
DeBary, Florida, United States
Research Site
DeLand, Florida, United States
Research Site
Doral, Florida, United States
Research Site
Edgewater, Florida, United States
Research Site
Fort Lauderdale, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Homestead, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Kissimmee, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Pensacola, Florida, United States
Research Site
Port Charlotte, Florida, United States
Research Site
Sarasota, Florida, United States
Research Site
South Miami, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Blue Ridge, Georgia, United States
Research Site
Lawrenceville, Georgia, United States
Research Site
Woodstock, Georgia, United States
Research Site
Nampa, Idaho, United States
Research Site
Evergreen Park, Illinois, United States
Research Site
O'Fallon, Illinois, United States
Research Site
Peoria, Illinois, United States
Research Site
River Forest, Illinois, United States
Research Site
Topeka, Kansas, United States
Research Site
Henderson, Kentucky, United States
Research Site
Owensboro, Kentucky, United States
Research Site
Opelousas, Louisiana, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Sunset, Louisiana, United States
Research Site
Bangor, Maine, United States
Research Site
Lutherville, Maryland, United States
Research Site
White Marsh, Maryland, United States
Research Site
Fall River, Massachusetts, United States
Research Site
Marlborough, Massachusetts, United States
Research Site
Buckley, Michigan, United States
Research Site
Kalamazoo, Michigan, United States
Research Site
Troy, Michigan, United States
Research Site
Edina, Minnesota, United States
Research Site
Fridley, Minnesota, United States
Research Site
Woodbury, Minnesota, United States
Research Site
Picayune, Mississippi, United States
Research Site
Port Gibson, Mississippi, United States
Research Site
Belton, Missouri, United States
Research Site
Florissant, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Missoula, Montana, United States
Research Site
Fremont, Nebraska, United States
Research Site
Omaha, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Marlton, New Jersey, United States
Research Site
Union, New Jersey, United States
Research Site
Brooklyn, New York, United States
Research Site
Great Neck, New York, United States
Research Site
Mineola, New York, United States
Research Site
New Windsor, New York, United States
Research Site
New York, New York, United States
Research Site
Potsdam, New York, United States
Research Site
The Bronx, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Burlington, North Carolina, United States
Research Site
Calabash, North Carolina, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Hickory, North Carolina, United States
Research Site
Mooresville, North Carolina, United States
Research Site
New Bern, North Carolina, United States
Research Site
Shelby, North Carolina, United States
Research Site
Chardon, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Marion, Ohio, United States
Research Site
Toledo, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Clackamas, Oregon, United States
Research Site
Medford, Oregon, United States
Research Site
Monroeville, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Uniontown, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
Hodges, South Carolina, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
Rapid City, South Dakota, United States
Research Site
Tullahoma, Tennessee, United States
Research Site
Corsicana, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Duncanville, Texas, United States
Research Site
Fort Worth, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Huntsville, Texas, United States
Research Site
Killeen, Texas, United States
Research Site
Lampasas, Texas, United States
Research Site
Longview, Texas, United States
Research Site
Lufkin, Texas, United States
Research Site
McKinney, Texas, United States
Research Site
McKinney, Texas, United States
Research Site
Plano, Texas, United States
Research Site
Sealy, Texas, United States
Research Site
Bountiful, Utah, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Abingdon, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Everett, Washington, United States
Research Site
Tacoma, Washington, United States
Research Site
Kingwood, West Virginia, United States
Research Site
Morgantown, West Virginia, United States
Research Site
Buenos Aires, , Argentina
Research Site
CABA, , Argentina
Research Site
CABA, , Argentina
Research Site
CABA, , Argentina
Research Site
CABA, , Argentina
Research Site
Ciudad Autónoma de Buenos Aire, , Argentina
Research Site
Ciudad de Buenos Aires, , Argentina
Research Site
Concepción del Uruguay, , Argentina
Research Site
Corrientes, , Argentina
Research Site
Córdoba, , Argentina
Research Site
Córdoba, , Argentina
Research Site
Florida, , Argentina
Research Site
Mar del Plata, , Argentina
Research Site
Mar del Plata, , Argentina
Research Site
Mendoza, , Argentina
Research Site
Mendoza, , Argentina
Research Site
Nueve de Julio, , Argentina
Research Site
Quilmes, , Argentina
Research Site
Rosario, , Argentina
Research Site
San Fernando, , Argentina
Research Site
San Juan Bautista, , Argentina
Research Site
San Miguel de Tucumán, , Argentina
Research Site
Clayton, , Australia
Research Site
Gosford, , Australia
Research Site
Murdoch, , Australia
Research Site
Nedlands, , Australia
Research Site
New Lambton, , Australia
Research Site
Woolloongabba, , Australia
Research Site
Brussels, , Belgium
Research Site
Genk, , Belgium
Research Site
Jambes, , Belgium
Research Site
Leuven, , Belgium
Research Site
Malmedy, , Belgium
Research Site
Turnhout, , Belgium
Research Site
Veurne, , Belgium
Research Site
Fortaleza, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
Rio de Janeiro, , Brazil
Research Site
Santo André, , Brazil
Research Site
São Paulo, , Brazil
Research Site
São Paulo, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Sorocaba, , Brazil
Research Site
Vitória, , Brazil
Research Site
Dupnitsa, , Bulgaria
Research Site
Kozloduy, , Bulgaria
Research Site
Pazardzhik, , Bulgaria
Research Site
Pernik, , Bulgaria
Research Site
Petrich, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Rousse, , Bulgaria
Research Site
Sandanski, , Bulgaria
Research Site
Silistra, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Vidin, , Bulgaria
Research Site
Vratsa, , Bulgaria
Research Site
Yambol, , Bulgaria
Research Site
Curicó, , Chile
Research Site
Quillota, , Chile
Research Site
Santiago, , Chile
Research Site
Santiago, , Chile
Research Site
Talca, , Chile
Research Site
Armenia, , Colombia
Research Site
Barranquilla, , Colombia
Research Site
Bogotá, , Colombia
Research Site
Bogotá, , Colombia
Research Site
Bogotá, , Colombia
Research Site
Cali, , Colombia
Research Site
Manizales, , Colombia
Research Site
Medellín, , Colombia
Research Site
Medillin, , Colombia
Research Site
Petrinja, , Croatia
Research Site
Aarhus N, , Denmark
Research Site
København NV, , Denmark
Research Site
Næstved, , Denmark
Research Site
Odense C, , Denmark
Research Site
Roskilde, , Denmark
Research Site
Silkeborg, , Denmark
Research Site
Bois-Guillaume, , France
Research Site
Brest, , France
Research Site
La Tronche, , France
Research Site
Lille, , France
Research Site
Lyon, , France
Research Site
Marseille, , France
Research Site
Montpellier, , France
Research Site
Nîmes, , France
Research Site
Orléans, , France
Research Site
Pessac, , France
Research Site
Haifa, , Israel
Research Site
Jerusalem, , Israel
Research Site
Jerusalem, , Israel
Research Site
Petah Tikva, , Israel
Research Site
Rehovot, , Israel
Research Site
Tel Aviv, , Israel
Research Site
Durango, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
México, , Mexico
Research Site
Monterrey, , Mexico
Research Site
Monterrey, , Mexico
Research Site
Auckland, , New Zealand
Research Site
Auckland, , New Zealand
Research Site
Dunedin, , New Zealand
Research Site
Greenlane, , New Zealand
Research Site
Hamilton West, , New Zealand
Research Site
Tauranga, , New Zealand
Research Site
Bodø, , Norway
Research Site
Kolbjørnsvik, , Norway
Research Site
Svelvik, , Norway
Research Site
Cusco, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Piura, , Peru
Research Site
Iloilo City, , Philippines
Research Site
Lipa City, , Philippines
Research Site
Manila, , Philippines
Research Site
Quezon City, , Philippines
Research Site
Quezon City, , Philippines
Research Site
Quezon City, , Philippines
Research Site
Bialystok, , Poland
Research Site
Bialystok, , Poland
Research Site
Bydgoszcz, , Poland
Research Site
Gdansk, , Poland
Research Site
Gorzów Wlkp, , Poland
Research Site
Grodzisk Mazowiecki, , Poland
Research Site
Karczew, , Poland
Research Site
Katowice, , Poland
Research Site
Krakow, , Poland
Research Site
Ostrowiec Świętokrzyski, , Poland
Research Site
Ostrów Wielkopolski, , Poland
Research Site
Ruda Śląska, , Poland
Research Site
Skierniewice, , Poland
Research Site
Sosnowiec, , Poland
Research Site
Starachowice, , Poland
Research Site
Szczecin, , Poland
Research Site
Słupca, , Poland
Research Site
Trzebnica, , Poland
Research Site
Wroclaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Żnin, , Poland
Research Site
Belgrade, , Serbia
Research Site
Celje, , Slovenia
Research Site
Golnik, , Slovenia
Research Site
Kamnik, , Slovenia
Research Site
Ljubljana, , Slovenia
Research Site
Maribor, , Slovenia
Research Site
Gothenburg, , Sweden
Research Site
Gothenburg, , Sweden
Research Site
Helsingborg, , Sweden
Research Site
Lund, , Sweden
Research Site
Malmo, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Uppsala, , Sweden
Research Site
Changhua, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
New Taipei City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Bangkok, , Thailand
Research Site
Bangkoknoi, , Thailand
Research Site
Hat Yai, , Thailand
Research Site
Khon Kaen, , Thailand
Research Site
Muang,, , Thailand
Research Site
Nonthaburi, , Thailand
Research Site
Adana, , Turkey (Türkiye)
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Bursa, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Research Site
Izmir, , Turkey (Türkiye)
Research Site
Izmir, , Turkey (Türkiye)
Research Site
Mersin, , Turkey (Türkiye)
Research Site
Cherkasy, , Ukraine
Research Site
Chernivtsi, , Ukraine
Research Site
Chernivtsi, , Ukraine
Research Site
Dnipropetrovsk, , Ukraine
Research Site
Ivano-Frankivsk, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Lutsk, , Ukraine
Research Site
Lviv, , Ukraine
Research Site
Odesa, , Ukraine
Research Site
Vinnytsia, , Ukraine
Research Site
Zaporizhzhya, , Ukraine
Research Site
Zaporizhzhya, , Ukraine
Research Site
Zaporizhzhya, , Ukraine
Research Site
Can Tho, , Vietnam
Research Site
Hanoi, , Vietnam
Research Site
Ho Chi Minh City, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Criner GJ, Celli BR, Singh D, Agusti A, Papi A, Jison M, Makulova N, Shih VH, Brooks L, Barker P, Martin UJ, Newbold P. Predicting response to benralizumab in chronic obstructive pulmonary disease: analyses of GALATHEA and TERRANOVA studies. Lancet Respir Med. 2020 Feb;8(2):158-170. doi: 10.1016/S2213-2600(19)30338-8. Epub 2019 Sep 28.
Criner GJ, Celli BR, Brightling CE, Agusti A, Papi A, Singh D, Sin DD, Vogelmeier CF, Sciurba FC, Bafadhel M, Backer V, Kato M, Ramirez-Venegas A, Wei YF, Bjermer L, Shih VH, Jison M, O'Quinn S, Makulova N, Newbold P, Goldman M, Martin UJ; GALATHEA Study Investigators; TERRANOVA Study Investigators. Benralizumab for the Prevention of COPD Exacerbations. N Engl J Med. 2019 Sep 12;381(11):1023-1034. doi: 10.1056/NEJMoa1905248. Epub 2019 May 20.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D3251C00004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.