AzTrials
AzTrials

Moderate to Very Severe Chronic Obstructive Pulmonary DiseasePhase 3GALATHEANCT02138916

Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History

A Phase 3 study testing Benralizumab Arm A and Benralizumab Arm B in people with Moderate to Very Severe Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 407 sites in 17 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies Read more about this study

Who is it for?
Ages 40 to 85 years
What is being tested?
Benralizumab Arm A and Benralizumab Arm B
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,656 participants
Where
407 sitesin 17 countries
Study dates
13 Jun 2014to 10 Apr 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Inclusion Criteria:1.Informed consent. 2.Subjects 40-85 y.o. 3.Moderate to very severe COPD with Post Bronchodilator (BD) FEV1>20% and ≤65%. 4.≥2 moderate or ≥1 severe COPD exacerbation(s) required treatment or hospitalization within 2-52 weeks prior to Visit1. 5. Modified Medical Research Council (mMRC) score ≥1 at Visit 1. 6.Treatment with double or triple therapy throughout the year prior to Visit 1, constant 2 weeks prior to Visit 1. 7.Tobacco history of ≥10 pack-years. 8.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. 9.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. 10.Compliance with maintenance therapy during run-in ≥70%. 11. 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: 1. Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.

  1. 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.
  2. 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.
  3. 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.
  4. Acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 2 weeks prior to Visit1or during the enrolment and run-in period.
  5. Pneumonia within 8 weeks prior to Visit1 or during the enrolment and run-in period.
  6. Pregnant, breastfeeding, or lactating women. 8. Risk factors for pneumonia 9. History of anaphylaxis to any other biologic therapy. 10. Long term oxygen therapy with signs and/or symptoms of cor pulmonale, right ventricular failure.
  7. Use of immunosuppressive medication within 2 weeks prior to Visit1 and/or during the enrolment and run-in period.
  8. Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1.
  9. Evidence of active tuberculosis (TB) without an appropriate course of treatment.
  10. 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).
  11. Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
  12. Previous treatment with benralizumab. 17. Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.

Trial locations and contacts

407 sites in 17 countries.

407 sites in 17 countries

United States138 sites

  • Research Site

    Albuquerque, New Mexico, 87108

  • Research Site

    Altoona, Pennsylvania, 16602

  • Research Site

    Andalusia, Alabama, 36420

  • Research Site

    Arlington, Texas, 76012

  • Research Site

    Asheville, North Carolina, 28801

  • Research Site

    Atlanta, Georgia, 30342

  • Research Site

    Aurora, Illinois, 60506

  • Research Site

    Austin, Texas, 78704

  • Research Site

    Baltimore, Maryland, 21201

  • Research Site

    Baltimore, Maryland, 21224

  • Research Site

    Bend, Oregon, 97701

  • Research Site

    Beverly Hills, California, 90212

  • Research Site

    Birmingham, Alabama, 35243

  • Research Site

    Birmingham, Alabama, 35294

  • Research Site

    Boerne, Texas, 78006

  • Research Site

    Boynton Beach, Florida, 33435

  • Research Site

    Brandon, Florida, 33511

  • Research Site

    Bronxville, New York, 10708

  • Research Site

    Brooklyn, New York, 11229

  • Research Site

    Buffalo, New York, 14215

  • Research Site

    Calhoun, Georgia, 30701

  • Research Site

    Canton, Ohio, 44718

  • Research Site

    Charleston, South Carolina, 29406

  • Research Site

    Charlotte, North Carolina, 28207

  • Research Site

    Chattanooga, Tennessee, 37404

  • Research Site

    Chicago, Illinois, 60602

  • Research Site

    Cincinnati, Ohio, 45220

  • Research Site

    Cincinnati, Ohio, 45231

  • Research Site

    Cincinnati, Ohio, 45242

  • Research Site

    Clearwater, Florida, 33756

  • Research Site

    Clearwater, Florida, 33765

  • Research Site

    Columbia, Maryland, 21044

  • Research Site

    Columbia, South Carolina, 29201

  • Research Site

    Dayton, Ohio, 45459

  • Research Site

    Decatur, Georgia, 30033

  • Research Site

    Dothan, Alabama, 36305

  • Research Site

    Duluth, Georgia, 30096

  • Research Site

    Durham, North Carolina, 27705

  • Research Site

    Eagle, Idaho, 83616

  • Research Site

    Elizabeth City, North Carolina, 27909

  • Research Site

    Erie, Pennsylvania, 16508

  • Research Site

    Evanston, Illinois, 60201

  • Research Site

    Farmington Hills, Michigan, 48336

  • Research Site

    Fayetteville, New York, 13066

  • Research Site

    Fort Lauderdale, Florida, 33316

  • Research Site

    Fort Mitchell, Kentucky, 41017

  • Research Site

    Franklin, Tennessee, 37067

  • Research Site

    Frisco, Texas, 75034

  • Research Site

    Gaffney, South Carolina, 29340

  • Research Site

    Gainesville, Florida, 32608

  • Research Site

    Galveston, Texas, 77555

  • Research Site

    Gastonia, North Carolina, 28054

  • Research Site

    Gold River, California, 95670

  • Research Site

    Greensboro, North Carolina, 27401

  • Research Site

    Greenville, South Carolina, 29615

  • Research Site

    Hazard, Kentucky, 41701

  • Research Site

    Hendersonville, Tennessee, 37075

  • Research Site

    Hialeah, Florida, 33012

  • Research Site

    Houston, Texas, 77077

  • Research Site

    Houston, Texas, 77081

  • Research Site

    Houston, Texas, 77084

  • Research Site

    Huntington Beach, California, 92647

  • Research Site

    Huntington Park, California, 90255-6046

  • Research Site

    Iowa City, Iowa, 52242

  • Research Site

    Jasper, Alabama, 35501

  • Research Site

    Jefferson Hills, Pennsylvania, 15025

  • Research Site

    Kissimmee, Florida, 34741

  • Research Site

    Lakewood, California, 90805

  • Research Site

    Las Vegas, Nevada, 89123

  • Research Site

    Little Rock, Arkansas, 72209

  • Research Site

    Lomita, California, 90717

  • Research Site

    Loxahatchee Groves, Florida, 33470

  • Research Site

    Marietta, Georgia, 30060

  • Research Site

    McAllen, Texas, 78504

  • Research Site

    Medford, Oregon, 97504

  • Research Site

    Miami, Florida, 33015

  • Research Site

    Miami, Florida, 33126

  • Research Site

    Miami, Florida, 33144

  • Research Site

    Miami, Florida, 33155

  • Research Site

    Miami Springs, Florida, 33166

  • Research Site

    Michigan City, Indiana, 46360

  • Research Site

    Midvale, Utah, 84047

  • Research Site

    Minneapolis, Minnesota, 55407

  • Research Site

    Mount Airy, North Carolina, 27030

  • Research Site

    Mt. Pleasant, South Carolina, 29464

  • Research Site

    New Bern, North Carolina, 28562

  • Research Site

    New Haven, Connecticut, 06520-8057

  • Research Site

    New York, New York, 10022

  • Research Site

    New York, New York, 10036

  • Research Site

    Newport Beach, California, 92663

  • Research Site

    North Dartmouth, Massachusetts, 02747

  • Research Site

    Oklahoma City, Oklahoma, 73103

  • Research Site

    Oklahoma City, Oklahoma, 73112

  • Research Site

    Oklahoma City, Oklahoma, 73116

  • Research Site

    Old Point Station, South Carolina, 29707

  • Research Site

    Orlando, Florida, 32803

  • Research Site

    Orlando, Florida, 32819

  • Research Site

    Orlando, Florida, 32825

  • Research Site

    Palm Desert, California, 92260

  • Research Site

    Palo Alto, California, 94304

  • Research Site

    Panama City, Florida, 32405

  • Research Site

    Philadelphia, Pennsylvania, 19140

  • Research Site

    Pittsburgh, Pennsylvania, 15213

  • Research Site

    Port Orange, Florida, 32129

  • Research Site

    Portland, Oregon, 97239

  • Research Site

    Provo, Utah, 84604

  • Research Site

    Rapid City, South Dakota, 57702

  • Research Site

    Richland, Washington, 99352

  • Research Site

    Richmond, Virginia, 23219

  • Research Site

    Richmond, Virginia, 23220

  • Research Site

    Richmond, Virginia, 23225

  • Research Site

    Richmond, Virginia, 23229

  • Research Site

    Riverside, California, 92506

  • Research Site

    Rochester, Michigan, 48307

  • Research Site

    Rock Hill, South Carolina, 29732

  • Research Site

    Sacramento, California, 95817

  • Research Site

    Saint Charles, Missouri, 63301

  • Research Site

    San Antonio, Texas, 78215

  • Research Site

    San Antonio, Texas, 78229

  • Research Site

    San Diego, California, 92103

  • Research Site

    Santa Ana, California, 92704

  • Research Site

    Sebring, Florida, 33870

  • Research Site

    Spartanburg, South Carolina, 29303

  • Research Site

    St Louis, Missouri, 63143

  • Research Site

    St. Petersburg, Florida, 33707

  • Research Site

    St. Petersburg, Florida, 33713

  • Research Site

    Summit, New Jersey, 07901

  • Research Site

    Thousand Oaks, California, 91360

  • Research Site

    Torrance, California, 90502

  • Research Site

    Tyler, Texas, 75708

  • Research Site

    Valparaiso, Indiana, 46383

  • Research Site

    Vero Beach, Florida, 32960

  • Research Site

    Waterbury, Connecticut, 06708

  • Research Site

    Wilmington, North Carolina, 28401

  • Research Site

    Winston-Salem, North Carolina, 27103

  • Research Site

    Winston-Salem, North Carolina, 27104

  • Research Site

    Winter Park, Florida, 32789-4681

  • Research Site

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Japan70 sites

  • Research Site

    Chūōku, 103-0027

  • Research Site

    Fukuoka, 811-1394

  • Research Site

    Fukuoka, 819-8555

  • Research Site

    Fukuyama-shi, 720-0001

  • Research Site

    Higashiibaraki-gun, 311-3193

  • Research Site

    Himeji-shi, 670-0849

  • Research Site

    Himeji-shi, 672-8064

  • Research Site

    Hirosaki-shi, 036-8545

  • Research Site

    Iwata-shi, 438-8550

  • Research Site

    Izumo-shi, 693-8501

  • Research Site

    Joyo-shi, 610-0113

  • Research Site

    Kagoshima, 890-0064

  • Research Site

    Kasuga-shi, 816-0813

  • Research Site

    Kasugai-shi, 486-8510

  • Research Site

    Kawaguchi-shi, 333-0833

  • Research Site

    Kawasaki-shi, 211-0041

  • Research Site

    Kiryu-shi, 376-0024

  • Research Site

    Kishiwada-shi, 596-8501

  • Research Site

    Kitakami-shi, 024-8506

  • Research Site

    Kobe, 650-0047

  • Research Site

    Kochi, 780-8077

  • Research Site

    Kodaira-shi, 187-0024

  • Research Site

    Kokubunji-shi, 185-0014

  • Research Site

    Koshi-shi, 861-1196

  • Research Site

    Kuki-shi, 349-1105

  • Research Site

    Kumamoto, 862-0921

  • Research Site

    Kurashiki-shi, 711-0921

  • Research Site

    Kurume-shi, 830-0011

  • Research Site

    Kyoto, 615-8256

  • Research Site

    Matsue, 690-8506

  • Research Site

    Matsue, 690-8556

  • Research Site

    Matsumoto-shi, 390-0872

  • Research Site

    Matsusaka-shi, 515-8544

  • Research Site

    Meguro-ku, 153-8515

  • Research Site

    Mizunami-shi, 509-6134

  • Research Site

    Morioka, 020-0055

  • Research Site

    Nagaoka-shi, 940-8621

  • Research Site

    Nagoya, 454-8509

  • Research Site

    Nagoya, 455-8530

  • Research Site

    Niigata, 950-2085

  • Research Site

    Obihiro-shi, 080-0805

  • Research Site

    Ohota-ku, 145-0063

  • Research Site

    Ota-shi, 373-8585

  • Research Site

    Saiki-shi, 876-0813

  • Research Site

    Sakaide-shi, 762-8550

  • Research Site

    Sakaishi, 591-8555

  • Research Site

    Sapporo, 001-0901

  • Research Site

    Sapporo, 060-0033

  • Research Site

    Sapporo, 063-0005

  • Research Site

    Sapporo, 064-0804

  • Research Site

    Sendai, 984-8560

  • Research Site

    Seto-shi, 489-8642

  • Research Site

    Shinagawa-ku, 142-8666

  • Research Site

    Shinjuku-ku, 162-8655

  • Research Site

    Takamatsu, 761-8073

  • Research Site

    Takatsuki-shi, 569-1096

  • Research Site

    Toon-shi, 791-0281

  • Research Site

    Toshima-ku, 171-0014

  • Research Site

    Ube-shi, 755-0241

  • Research Site

    Ueda-shi, 386-8610

  • Research Site

    Uji-shi, 611-0041

  • Research Site

    Urasoe-shi, 901-2132

  • Research Site

    Uruma, 904-2293

  • Research Site

    Yachiyo-shi, 276-8524

  • Research Site

    Yakushi, 581-0011

  • Research Site

    Yanagawa-shi, 832-0059

  • Research Site

    Yokohama, 232-0024

  • Research Site

    Yokohama, 234-0054

  • Research Site

    Yokohama, 236-0004

  • Research Site

    Yokohama, 236-0051

Other trials in Japan

Russia41 sites

  • Research Site

    Chelyabinsk, 454021

  • Research Site

    Ivanovo, 153005

  • Research Site

    Izhevsk, 426035

  • Research Site

    Kazan', 420012

  • Research Site

    Kemerovo, 650000

  • Research Site

    Kemerovo, 650002

  • Research Site

    Kemerovo, 650066

  • Research Site

    Moscow, 109240

  • Research Site

    Moscow, 117593

  • Research Site

    Moscow, 121309

  • Research Site

    Moscow, 127018

  • Research Site

    Moscow, 127473

  • Research Site

    Nizhny Novgorod, 603126

  • Research Site

    Novosibirsk, 630008

  • Research Site

    Novosibirsk, 630051

  • Research Site

    Novosibirsk, 630084

  • Research Site

    Penza, 440067

  • Research Site

    Perm, 614068

  • Research Site

    Pskov, 180007

  • Research Site

    Pyatigorsk, 357500

  • Research Site

    Ryazan, 390026

  • Research Site

    Saint Petersburg, 193312

  • Research Site

    Saint Petersburg, 194354

  • Research Site

    Saint Petersburg, 196084

  • Research Site

    Saint Petersburg, 196247

  • Research Site

    Saint Petersburg, 197089

  • Research Site

    Saint Petersburg, 197342

  • Research Site

    Saratov, 410012

  • Research Site

    Smolensk, 214019

  • Research Site

    Tomsk, 634050

  • Research Site

    Tomsk, 634063

  • Research Site

    Ufa, 450071

  • Research Site

    Ulyanovsk, 432009

  • Research Site

    Vladikavkaz, 362007

  • Research Site

    Vladimir, 600023

  • Research Site

    Volgograd, 400001

  • Research Site

    Volgograd, 400131

  • Research Site

    Yekaterinburg, 620039

  • Research Site

    Yekaterinburg, 620109

  • Research Site

    Yekaterinburg, 620137

  • Research Site

    Yekaterinburg, 620219

Other trials in Russia

Poland24 sites

  • Research Site

    Bydgoszcz, 85-681

  • Research Site

    Dobre Miasto, 11-040

  • Research Site

    Gdansk, 80-405

  • Research Site

    Gdansk

  • Research Site

    Katowice, 40-081

  • Research Site

    Kościan, 64-000

  • Research Site

    Krakow, 31-011

  • Research Site

    Krakow, 31-209

  • Research Site

    Lodz, 90-153

  • Research Site

    Lublin, 20-064

  • Research Site

    Lublin, 20-089

  • Research Site

    Lublin, 20-468

  • Research Site

    Mrągowo, 11-700

  • Research Site

    Mrozy, 05-320

  • Research Site

    Olsztyn, 10-357

  • Research Site

    Proszowice, 32-100

  • Research Site

    Radom, 26-617

  • Research Site

    Ruda Śląska, 41-709

  • Research Site

    Rzeszów, 35-241

  • Research Site

    Tarnów, 33-100

  • Research Site

    Warsaw, 02-507

  • Research Site

    Wroclaw, 50-220

  • Research Site

    Wroclaw, 53-201

  • Research Site

    Zakopane

Other trials in Poland

United Kingdom18 sites

  • Research Site

    Aberdeen, AB25 2ZG

  • Research Site

    Birmingham, B9 5SS

  • Research Site

    Bradford, BD9 6RJ

  • Research Site

    Cambridge, CB2 0QQ

  • Research Site

    Chertsey, KT16 0PZ

  • Research Site

    Edinburgh, EH16 4TJ

  • Research Site

    Glasgow, G12 0YN

  • Research Site

    LE3 9QP

  • Research Site

    London, SE5 9PJ

  • Research Site

    Manchester, M23 9QZ

  • Research Site

    Manchester, M6 8HD

  • Research Site

    Newcastle upon Tyne, NE7 7DN

  • Research Site

    Newcastle-under-Lyme, ST4 6QG

  • Research Site

    Oxford, OX3 7LE

  • Research Site

    Plymouth, PL6 8DH

  • Research Site

    Southampton, SO166YD

  • Research Site

    Wishaw, ML2 0DP

  • Research Site

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Canada17 sites

  • Research Site

    Ajax, Ontario, L1Z 0M1

  • Research Site

    Burlington, Ontario, L7N 3V2

  • Research Site

    Calgary, Alberta, T2N 4Z6

  • Research Site

    Calgary, Alberta, T2Y 2Z7

  • Research Site

    Grimsby, Ontario, L3M 1P3

  • Research Site

    Hamilton, Ontario, L8N 3Z5

  • Research Site

    Montreal, Quebec, H4J 1C5

  • Research Site

    Pointe-Claire, Quebec, H9R 3J1

  • Research Site

    Québec, Quebec, G1G 3Y8

  • Research Site

    Québec, Quebec, G1V 4G5

  • Research Site

    Québec, Quebec, G1V 4W2

  • Research Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • Research Site

    Saskatoon, Saskatchewan, S7N 0W8

  • Research Site

    Sherwood Park, Alberta, T8L 0N2

  • Research Site

    Trois-Rivières, Quebec, G8T 7A1

  • Research Site

    Vancouver, British Columbia, V5Z 1M9

  • Research Site

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Germany15 sites

  • Research Site

    Bamberg, 96049

  • Research Site

    Berlin, 10787

  • Research Site

    Berlin, 13187

  • Research Site

    Bonn, 53123

  • Research Site

    Frankfurt, 60596

  • Research Site

    Frankfurt am Main, 60389

  • Research Site

    Frankfurt am Main, 60596

  • Research Site

    Geesthacht, 21502

  • Research Site

    Hamburg, 20354

  • Research Site

    Leipzig, 04357

  • Research Site

    Marburg, 35043

  • Research Site

    Neu-Isenburg, 63263

  • Research Site

    Rodgau-Dudenhofen, 63110

  • Research Site

    Teuchern, 06682

  • Research Site

    Witten, 58452

Other trials in Germany

Hungary15 sites

  • Research Site

    Balassagyarmat, 2660

  • Research Site

    Budapest, 1135

  • Research Site

    Budapest, 1204

  • Research Site

    Edelény, 3780

  • Research Site

    Farkasgyepü, 8582

  • Research Site

    Gödöllő, 2100

  • Research Site

    Hajdúnánás, 4080

  • Research Site

    Hatvan, 3000

  • Research Site

    Mátraháza, 3233

  • Research Site

    Miskolc, 3529

  • Research Site

    Pécs, 7626

  • Research Site

    Pécs, 7635

  • Research Site

    Százhalombatta, 2440

  • Research Site

    Szeged, H-6722

  • Research Site

    Székesfehérvár, 8000

Other trials in Hungary

Spain11 sites

  • Research Site

    Alicante, 03004

  • Research Site

    Badalona(Barcelona), 08916

  • Research Site

    Barcelona, 08003

  • Research Site

    Barcelona, 08025

  • Research Site

    Barcelona, 08036

  • Research Site

    Madrid, 28040

  • Research Site

    Málaga, 29010

  • Research Site

    Palma de Mallorca, 07010

  • Research Site

    Sabadell (Barcelona), 08208

  • Research Site

    Santander, 39008

  • Research Site

    Valencia, 46015

Other trials in Spain

Italy10 sites

  • Research Site

    Bolzano, 39100

  • Research Site

    Catania, 95123

  • Research Site

    Ferrara, 44100

  • Research Site

    Genova, 16132

  • Research Site

    Orbassano, 10043

  • Research Site

    Palermo, 90146

  • Research Site

    Parma, 43100

  • Research Site

    Pavia, 27100

  • Research Site

    Pisa, 56124

  • Research Site

    Tradate, 21049

Other trials in Italy

Czechia9 sites

  • Research Site

    Jindřichův Hradec, 377 01

  • Research Site

    Karlovy Vary, 360 17

  • Research Site

    Kralupy nad Vltavou, 278 01

  • Research Site

    Mladá Boleslav, 293 50

  • Research Site

    Olomouc, 775 21

  • Research Site

    Prague, 182 00

  • Research Site

    Rokycany, 337 22

  • Research Site

    Strakonice, 386 01

  • Research Site

    Teplice, 415 01

Other trials in Czechia

Romania8 sites

  • Research Site

    Bragadiru, 077025

  • Research Site

    Brasov, 500283

  • Research Site

    Bucharest, 030303

  • Research Site

    Bucharest, 71593

  • Research Site

    Constanța, 900002

  • Research Site

    Deva, 330061

  • Research Site

    Iași, 700115

  • Research Site

    Timișoara, 300310

Other trials in Romania

Austria7 sites

  • Research Site

    Feldkirch, 6800

  • Research Site

    Graz, 8036

  • Research Site

    Innsbruck, 6020

  • Research Site

    Linz, 4020

  • Research Site

    Salzburg, 5020

  • Research Site

    Vienna, 1140

  • Research Site

    Wels, 4600

Other trials in Austria

South Korea7 sites

  • Research Site

    Bucheon-si, 14584

  • Research Site

    Daegu, 42415

  • Research Site

    Seoul, 03312

  • Research Site

    Seoul, 04401

  • Research Site

    Seoul, 05030

  • Research Site

    Seoul, 06591

  • Research Site

    Wŏnju, 26426

Other trials in South Korea

Netherlands6 sites

  • Research Site

    Breda, 4818 CK

  • Research Site

    Eindhoven, 5623 EJ

  • Research Site

    Heerlen, 6419 PC

  • Research Site

    Horn, 6085 NM

  • Research Site

    Nijmegen, 6525 GA

  • Research Site

    Zwolle, 8025 AB

Other trials in Netherlands

South Africa6 sites

  • Research Site

    Bloemfontein, 9301

  • Research Site

    Cape Town, 7764

  • Research Site

    Durban, 4001

  • Research Site

    eManzimtoti, 4126

  • Research Site

    Gauteng, 2193

  • Research Site

    Middelburg, 1055

Other trials in South Africa

Switzerland5 sites

  • Research Site

    Basel, 4031

  • Research Site

    Biel, 2502

  • Research Site

    Gossau, CH-9202

  • Research Site

    Liestal, CH-4410

  • Research Site

    Sankt Gallen, 9007

Other trials in Switzerland

About this study

Official title: Randomised, Double-blind, 56 Week Placebo-controlled, Parallel Group, Multicentre, Phase 3 Study to Evaluate the Efficacy and Safety of 2 Doses of Benralizumab in Patients With Moderate to Very Severe COPD With a History of Exacerbations

The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies

Being tested
Benralizumab Arm A, Benralizumab Arm B, Placebo
Keywords
Obstructive Lung Diseases, Chronic Obstructive Pulmonary Disease, Lung Disease, Bronchial Diseases, COPD Exacerbation, Respiratory Tract Diseases
Medical subject headings
Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Bronchial Diseases, Respiratory Tract Diseases

What participants receive

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

  • Benralizumab Arm ADrug

    Benralizumab subcutaneously on study week 0 until study week 48 inclusive

  • Benralizumab Arm BDrug

    Benralizumab subcutaneously on study week 0 until study week 48 inclusive

  • PlaceboDrug

    Placebo subcutaneously on study week 0 until study week 48 inclusive

Study groups in NCT02138916
Study groupRoleWhat they receive
Benralizumab Arm AExperimentalBenralizumab administered subcutaneously
Receives: Drug: Benralizumab Arm A
Benralizumab Arm BExperimentalBenralizumab administered subcutaneously
Receives: Drug: Benralizumab Arm B
PlaceboPlacebo comparatorPlacebo administered subcutaneously
Receives: Drug: Placebo

What is being measured

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

  1. Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL

    A COPD exacerbation is defined by symptomatic worsening of COPD requiring:

    • Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or
    • Use of antibiotics; and/or
    • An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.

    Measured: From first IP to week 56

Secondary outcomes (18)

  1. Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL

    A COPD exacerbation is defined by symptomatic worsening of COPD requiring:

    • Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or
    • Use of antibiotics; and/or
    • An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.

    Measured: From first IP to week 56

  2. Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL

    Pre-bronchodilator FEV1 (L) is collected at Weeks 0, 4, 8, 16, 24, 32, 40, 48, and 56. Baseline is the last non-missing value with quality (acceptable or borderline quality grade) prior to the first dose of study treatment.

    Measured: First IP up to end of treatment Week 56

  3. Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL

    SGRQ is from 50-item PRO instrument. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0 indicates the best possible health status.

    Measured: First IP up to Week 56

  4. Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL

    CAT is an 8-item PRO developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. Score ranges from 0 to 40 with higher scores indicative of greater COPD impact on health status.

    Measured: First IP up to Week 56

  5. Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL

    The E-RS: COPD is an 11-item PRO developed to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS: COPD item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity.

    Measured: First IP up to Week 56

  6. Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL

    The number of rescue medication inhalations and nebulizer treatments taken are recorded by the patient in the eDiary twice daily. Total rescue medication use is the sum of daytime and night-time use.

    Measured: First IP up to Week 56

  7. Mean Change From Baseline in Proportion of Nights Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL

    Change from baseline to week 56 in proportion of nights awakenings due to respiratory symptoms.

    Measured: First IP up to Week 56

  8. Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL

    The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Exacerbation event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an exacerbation event has occurred.

    Measured: Immediately following first IP up to week 56

  9. Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL

    The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Severity for the study is the highest score of EXACT-PRO.

    Measured: Immediately following first IP up to week 56

  10. Duration of EXACT-PRO for Patients With Baseline EOS>=220/uL

    The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Calculation of event duration after identification of the following five parameters: 1) onset; 2) three-day rolling average; 3) maximum observed value; 4) threshold for improvement; and 5) recovery. That is, duration of the exacerbation is the time elapse between onset and recovery of the event.

    Measured: Immediately following first IP up to week 56

  11. Annual EXACT-PRO Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL

    The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Annual EXACT-PRO exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.

    Measured: Immediately following first IP up to week 56

  12. Number of Participants Having at Least 1 COPD Exacerbation for Patients With Baseline EOS>=220/uL

    A COPD exacerbation is defined by symptomatic worsening COPD requiring systemic corticosteroids, antibiotics, or an inpatient hospitalization/death due to COPD.

    Measured: Immediately following first IP up to week 56

  13. Time to First COPD Exacerbation

    Time to first COPD exacerbation is from the randomization date to the first occurrence of COPD exacerbation

    Measured: Immediately following first IP up to week 56

  14. Annual COPD Exacerbation Rate Associated With ER or Hospitalization Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL

    Annual COPD exacerbations rate that result in ER or hospitalization is calculated by number of exacerbations resulting ER or hospitalization divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.

    Measured: Immediately following first IP up to week 56

  15. Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL

    Types of healthcare encounter: Hospitalisations (inc. intensive care and/or general care), Emergency department visits, Unscheduled outpatients visits, Home visits, Telephone calls, and ambulance transports.

    Measured: Immediately following first IP up to week 56

  16. Duration of Study Treatment Administration

    Duration of study treatment is calculated from first dose date to last dose date + 1 day.

    Measured: From first dose date to last dose date, 48 weeks per protocol.

  17. Serum Concentration of Benralizumab

    PK serum samples were collected pre-dose at each visit.

    Measured: Pre-first dose and pre-dose at end of treatment (week 56)

  18. Immunogenicity of Benralizumab

    Antidrug antibody (ADA) responses such as ADA prevalence, ADA incidence, ADA persistently positive counts, etc. were presented

    Measured: Pre-treatment until end of follow-up, week 60 per protocol.

Timeline

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

  1. First posted15 May 2014 (estimated)
  2. Study start13 Jun 2014
  3. Primary completion10 Apr 2018
  4. Study completion10 Apr 2018

Resources

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
1,656 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02138916
Sponsor's protocol ID
D3251C00003
Acronym
GALATHEA
Status last verified
Jun 2019
First submitted
26 Mar 2014
Last updated
13 Jun 2019
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31575508

  • 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.

    PubMed 31112385

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Benralizumab Arm A and Benralizumab Arm B in people with Moderate to Very Severe Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 407 sites in 17 countries.

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

Who may be eligible to take part?

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 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 407 sites in United States, Japan, Russia, Poland, United Kingdom and 12 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?

Yes. Results are posted in the registry (first posted 13 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL (time frame: From first IP to week 56). 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 NCT02138916, which also lists 2 linked publications.

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 13 Jun 2019.

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