Moderate to Very Severe Chronic Obstructive Pulmonary DiseasePhase 3TERRANOVANCT02155660

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

A Phase 3 study testing Benralizumab Arm A, Benralizumab Arm B and Benralizumab Arm C in people with Moderate to Very Severe Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 356 sites in 26 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

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
Conditions the study is for: Moderate to Very Severe Chronic Obstructive Pulmonary Disease
What is being tested?: Benralizumab Arm A, Benralizumab Arm B and Benralizumab Arm C
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,255 participants
Where: 356 sitesin 26 countries
Study dates: 25 Jun 2014to 9 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

Who may be able to join

Informed consent.
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.

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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.

Who cannot join

Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
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.

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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.

Trial locations and contacts

356 sites in 26 countries.

Country

City, postcode or hospital

356 sites in 26 countries

United States151 sites

Research Site
Abingdon, Virginia, 24210
Research Site
Anaheim, California, 92801
Research Site
Arcadia, California, 91007
Research Site
Atlanta, Georgia, 30331
Research Site
Bakersfield, California, 93301
Research Site
Bangor, Maine, 04401
Research Site
Belton, Missouri, 64012
Research Site
Birmingham, Alabama, 35216
Research Site
Blue Ridge, Georgia, 30513
Research Site
Bountiful, Utah, 84010
Research Site
Brooklyn, New York, 11236
Research Site
Buckley, Michigan, 49620
Research Site
Burlington, North Carolina, 27215
Research Site
Calabash, North Carolina, 28467
Research Site
Centennial, Colorado, 80112
Research Site
Chardon, Ohio, 44024
Research Site
Charleston, South Carolina, 29412
Research Site
Charlotte, North Carolina, 28277
Research Site
Chiefland, Florida, 32626
Research Site
Cincinnati, Ohio, 45242
Research Site
Clackamas, Oregon, 97015-6804
Research Site
Clearwater, Florida, 33759
Research Site
Clearwater, Florida, 33765
Research Site
Coconut Creek, Florida, 33066
Research Site
Colorado Springs, Colorado, 80907
Research Site
Columbus, Ohio, 43213
Research Site
Columbus, Ohio, 43214
Research Site
Coral Gables, Florida, 33134
Research Site
Corsicana, Texas, 75110
Research Site
Dallas, Texas, 75216
Research Site
Daytona Beach, Florida, 32117
Research Site
DeBary, Florida, 32713
Research Site
DeLand, Florida, 32720
Research Site
Denver, Colorado, 80246
Research Site
Doral, Florida, 33172
Research Site
Duncanville, Texas, 75116
Research Site
Edgewater, Florida, 32132
Research Site
Edina, Minnesota, 55435
Research Site
Everett, Washington, 98208
Research Site
Evergreen Park, Illinois, 60805
Research Site
Fall River, Massachusetts, 02720
Research Site
Flagstaff, Arizona, 86001
Research Site
Florissant, Missouri, 63033
Research Site
Fort Lauderdale, Florida, 33308
Research Site
Fort Worth, Texas, 76104
Research Site
Fremont, Nebraska, 68025
Research Site
Fresno, California, 93721
Research Site
Fridley, Minnesota, 55432
Research Site
Fullerton, California, 92835
Research Site
Great Neck, New York, 11023
Research Site
Gulf Shores, Alabama, 36542
Research Site
Hawaiian Gardens, California, 90716
Research Site
Henderson, Kentucky, 42420
Research Site
Hialeah, Florida, 33010
Research Site
Hialeah, Florida, 33012
Research Site
Hialeah, Florida, 33013
Research Site
Hickory, North Carolina, 28601
Research Site
Hodges, South Carolina, 29653
Research Site
Homestead, Florida, 33130
Research Site
Houston, Texas, 77024
Research Site
Houston, Texas, 77034
Research Site
Houston, Texas, 77036
Research Site
Houston, Texas, 77043
Research Site
Houston, Texas, 77055
Research Site
Houston, Texas, 77063
Research Site
Houston, Texas, 78756
Research Site
Huntington Beach, California, 92647
Research Site
Huntsville, Texas, 77340
Research Site
Jacksonville, Florida, 32204
Research Site
Kalamazoo, Michigan, 49009
Research Site
Killeen, Texas, 76543
Research Site
Kingwood, West Virginia, 26357
Research Site
Kissimmee, Florida, 34744
Research Site
Lampasas, Texas, 76550
Research Site
Las Vegas, Nevada, 89146
Research Site
Lawrenceville, Georgia, 30046
Research Site
Longview, Texas, 75604
Research Site
Los Angeles, California, 90048
Research Site
Lufkin, Texas, 75904
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Lutherville, Maryland, 21093
Research Site
Marion, Ohio, 43302
Research Site
Marlborough, Massachusetts, 01752
Research Site
Marlton, New Jersey, 08053
Research Site
McKinney, Texas, 75069
Research Site
McKinney, Texas, 75071
Research Site
Medford, Oregon, 97504
Research Site
Miami, Florida, 33126
Research Site
Miami, Florida, 33144
Research Site
Miami, Florida, 33147
Research Site
Miami, Florida, 33155
Research Site
Miami, Florida, 33165
Research Site
Miami, Florida, 33174
Research Site
Miami, Florida, 33186
Research Site
Mineola, New York, 11501
Research Site
Missoula, Montana, 59808
Research Site
Monroeville, Pennsylvania, 15146
Research Site
Montgomery, Alabama, 36117
Research Site
Mooresville, North Carolina, 28117
Research Site
Morgantown, West Virginia, 26505
Research Site
Nampa, Idaho, 83687
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New Bern, North Carolina, 28562
Research Site
New Windsor, New York, 12553
Research Site
New York, New York, 10016
Research Site
Northridge, California, 91324
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O'Fallon, Illinois, 62269
Research Site
Oklahoma City, Oklahoma, 73103
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Oklahoma City, Oklahoma, 73112
Research Site
Omaha, Nebraska, 68124
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Opelousas, Louisiana, 70570
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Owensboro, Kentucky, 42303
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Palmdale, California, 93551
Research Site
Peninsula, California, 90505
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Pensacola, Florida, 32504
Research Site
Peoria, Illinois, 61602
Research Site
Philadelphia, Pennsylvania, 19142
Research Site
Phoenix, Arizona, 85018
Research Site
Picayune, Mississippi, 39466
Research Site
Pittsburgh, Pennsylvania, 15213
Research Site
Pittsburgh, Pennsylvania, 15243
Research Site
Placentia, California, 92870
Research Site
Plano, Texas, 75093
Research Site
Port Charlotte, Florida, 33952
Research Site
Port Gibson, Mississippi, 39150
Research Site
Potsdam, New York, 13676
Research Site
Rapid City, South Dakota, 57702
Research Site
Richmond, Virginia, 23220
Research Site
Richmond, Virginia, 23235
Research Site
River Forest, Illinois, 60305
Research Site
Rolling Hills Estates, California, 90274
Research Site
Salt Lake City, Utah, 84102
Research Site
Sarasota, Florida, 34239
Research Site
Sealy, Texas, 77474
Research Site
Shelby, North Carolina, 28150
Research Site
Shreveport, Louisiana, 71106
Research Site
South Miami, Florida, 33143
Research Site
Spartanburg, South Carolina, 29303
Research Site
St Louis, Missouri, 63136
Research Site
Sunset, Louisiana, 70584
Research Site
Tacoma, Washington, 98405
Research Site
The Bronx, New York, 10459
Research Site
The Bronx, New York, 10461
Research Site
Toledo, Ohio, 43617
Research Site
Topeka, Kansas, 66606
Research Site
Troy, Michigan, 48085
Research Site
Tullahoma, Tennessee, 37388
Research Site
Union, New Jersey, 07083
Research Site
Uniontown, Pennsylvania, 15401
Research Site
Westminster, California, 92683
Research Site
White Marsh, Maryland, 21162
Research Site
Woodbury, Minnesota, 55125
Research Site
Woodstock, Georgia, 30189

Other trials in United States

Argentina22 sites

Research Site
Buenos Aires, C1414AIF
Research Site
CABA, 1426
Research Site
CABA, C1056ABJ
Research Site
CABA, C1425BEN
Research Site
CABA, C1431FWO
Research Site
Ciudad Autónoma de Buenos Aire, C1440BRR
Research Site
Ciudad de Buenos Aires, 1425
Research Site
Concepción del Uruguay, 3260
Research Site
Córdoba, X5003DCE
Research Site
Córdoba, X5014KEH
Research Site
Corrientes, 3400
Research Site
Florida, 1638
Research Site
Mar del Plata, 7600
Research Site
Mar del Plata, B7600GNY
Research Site
Mendoza, 5500
Research Site
Mendoza, M5500GIP
Research Site
Nueve de Julio, B6500EZL
Research Site
Quilmes, B1878FNR
Research Site
Rosario, S2000DEJ
Research Site
San Fernando, 1646
Research Site
San Juan Bautista, 1888
Research Site
San Miguel de Tucumán, T4000IAR

Other trials in Argentina

Poland21 sites

Research Site
Bialystok, 15-044
Research Site
Bialystok, 15-351
Research Site
Bydgoszcz, 85-231
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Gdansk, 80-952
Research Site
Gorzów Wlkp, 66-400
Research Site
Grodzisk Mazowiecki, 05-825
Research Site
Karczew, 05-480
Research Site
Katowice, 40-648
Research Site
Krakow, 30-901
Research Site
Ostrów Wielkopolski, 63-400
Research Site
Ostrowiec Świętokrzyski, 27-400
Research Site
Ruda Śląska, 41-707
Research Site
Skierniewice, 96-100
Research Site
Słupca, 62-400
Research Site
Sosnowiec, 41-200
Research Site
Starachowice, 27-200
Research Site
Szczecin, 70-111
Research Site
Trzebnica, 55-100
Research Site
Wroclaw, 51-162
Research Site
Wroclaw, 53-301
Research Site
Żnin, 88-400

Other trials in Poland

Ukraine16 sites

Research Site
Cherkasy, 18009
Research Site
Chernivtsi, 58000
Research Site
Chernivtsi, 58022
Research Site
Dnipropetrovsk, 49051
Research Site
Ivano-Frankivsk, 76012
Research Site
Kharkiv, 61035
Research Site
Kharkiv, 61039
Research Site
Kyiv, 03680
Research Site
Kyiv, 04107
Research Site
Lutsk, 43000
Research Site
Lviv, 79066
Research Site
Odesa, 65025
Research Site
Vinnytsia, 21001
Research Site
Zaporizhzhya, 69063
Research Site
Zaporizhzhya, 69065
Research Site
Zaporizhzhya, 69068

Other trials in Ukraine

Bulgaria14 sites

Research Site
Dupnitsa, 2600
Research Site
Kozloduy, 3320
Research Site
Pazardzhik, 4400
Research Site
Pernik, 2300
Research Site
Petrich, 2850
Research Site
Plovdiv, 4002
Research Site
Rousse, 7002
Research Site
Sandanski, 2800
Research Site
Silistra
Research Site
Sofia, 1002
Research Site
Sofia, 1408
Research Site
Vidin, 3700
Research Site
Vratsa, 3000
Research Site
Yambol, 8600

Other trials in Bulgaria

Brazil12 sites

Research Site
Fortaleza, 60864190
Research Site
Porto Alegre, 90035-074
Research Site
Porto Alegre, 90470-340
Research Site
Porto Alegre, 90610-000
Research Site
Porto Alegre, 91350-200
Research Site
Rio de Janeiro, 22271-100
Research Site
Santo André, 09080-110
Research Site
São Paulo, 04020060
Research Site
São Paulo, 04023-062
Research Site
São Paulo, 05403-000
Research Site
Sorocaba, 18040-425
Research Site
Vitória, 29055-450

Other trials in Brazil

France10 sites

Research Site
Bois-Guillaume, 76031
Research Site
Brest, 29609
Research Site
La Tronche, 38700
Research Site
Lille, 59037
Research Site
Lyon, 69317
Research Site
Marseille, 13915
Research Site
Montpellier, 34295
Research Site
Nîmes, 30029
Research Site
Orléans, 45100
Research Site
Pessac, 33604

Other trials in France

Peru10 sites

Research Site
Cusco, CUSCO 01
Research Site
Lima, 15033
Research Site
Lima, 41
Research Site
Lima, L27
Research Site
Lima, L41
Research Site
Lima, LIMA 1
Research Site
Lima, LIMA 21
Research Site
Lima, LIMA 31
Research Site
Lima, LIMA 33
Research Site
Piura

Other trials in Peru

Colombia9 sites

Research Site
Armenia, 630004
Research Site
Barranquilla, 80001
Research Site
Bogotá, 110221
Research Site
Bogotá, 111511
Research Site
Bogotá
Research Site
Cali, 76001000
Research Site
Manizales, 17001
Research Site
Medellín, 5001000
Research Site
Medillin

Other trials in Colombia

Turkey (Türkiye)9 sites

Research Site
Adana, 01330
Research Site
Ankara, 06280
Research Site
Bursa, 16059
Research Site
Istanbul, 34020
Research Site
Istanbul, 34098
Research Site
Istanbul, 34844
Research Site
Izmir, 35100
Research Site
Izmir, 35110
Research Site
Mersin, 33343

Other trials in Turkey (Türkiye)

Taiwan8 sites

Research Site
Changhua, 500
Research Site
Kaohsiung City, 83301
Research Site
Kaohsiung City
Research Site
New Taipei City, 22056
Research Site
Taichung, 40447
Research Site
Taichung, 40705
Research Site
Taipei, 112
Research Site
Taipei

Other trials in Taiwan

Belgium7 sites

Research Site
Brussels, 1020
Research Site
Genk, 3600
Research Site
Jambes, 5100
Research Site
Leuven, 3000
Research Site
Malmedy, 4960
Research Site
Turnhout, 2300
Research Site
Veurne, 8630

Other trials in Belgium

Sweden7 sites

Research Site
Gothenburg, 405 30
Research Site
Gothenburg, 41345
Research Site
Helsingborg, 252 20
Research Site
Lund, 221 85
Research Site
Malmö, 21152
Research Site
Stockholm, 114 46
Research Site
Uppsala, 751 85

Other trials in Sweden

Australia6 sites

Research Site
Clayton, 3168
Research Site
Gosford, 2250
Research Site
Murdoch, 6150
Research Site
Nedlands, 6009
Research Site
New Lambton, 2310
Research Site
Woolloongabba, 4102

Other trials in Australia

Denmark6 sites

Research Site
Aarhus N, 8200
Research Site
København NV, 2400
Research Site
Næstved, 4700
Research Site
Odense C, 5000
Research Site
Roskilde, 4000
Research Site
Silkeborg, 8600

Other trials in Denmark

Israel6 sites

Research Site
Haifa, 34362
Research Site
Jerusalem, 91120
Research Site
Jerusalem, 9372212
Research Site
Petah Tikva, 49100
Research Site
Rehovot, 7661041
Research Site
Tel Aviv, IL-

Other trials in Israel

Mexico6 sites

Research Site
Durango, 43080
Research Site
Guadalajara, 44130
Research Site
Guadalajara, 44200
Research Site
México, 14050
Research Site
Monterrey, 64460
Research Site
Monterrey, 66465

Other trials in Mexico

New Zealand6 sites

Research Site
Auckland, 0626
Research Site
Auckland, 2025
Research Site
Dunedin, 9016
Research Site
Greenlane, 1051
Research Site
Hamilton West, 3204
Research Site
Tauranga, 3112

Other trials in New Zealand

Philippines6 sites

Research Site
Iloilo City, 5000
Research Site
Lipa City
Research Site
Manila, 1000
Research Site
Quezon City, 1100
Research Site
Quezon City, 1101
Research Site
Quezon City, 1109

Other trials in Philippines

Thailand6 sites

Research Site
Bangkok, 10600
Research Site
Bangkoknoi, 10700
Research Site
Hat Yai, 90110
Research Site
Khon Kaen, 40002
Research Site
Muang,, 55000
Research Site
Nonthaburi, 11000

Other trials in Thailand

Chile5 sites

Research Site
Curicó, 3341643
Research Site
Quillota, 2260000
Research Site
Santiago, 7500698
Research Site
Santiago, 7500800
Research Site
Talca, 3465584

Other trials in Chile

Slovenia5 sites

Research Site
Celje, 3000
Research Site
Golnik, 4204
Research Site
Kamnik, 1241
Research Site
Ljubljana, 1000
Research Site
Maribor, 2000

Other trials in Slovenia

Norway3 sites

Research Site
Bodø, N-8092
Research Site
Kolbjørnsvik, N-4816
Research Site
Svelvik, 3060

Other trials in Norway

Vietnam3 sites

Research Site
Can Tho, 900000
Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 700000

Other trials in Vietnam

Croatia1 site

Research Site
Petrinja, 44250

Other trials in Croatia

Serbia1 site

Research Site
Belgrade, 11000

Other trials in Serbia

About this study

Official title: A Randomised, Double-blind, Double Dummy, 56 Week Placebo-controlled, Multicentre, Parallel Group, Phase 3 Study Evaluating Efficacy/Safety of 3 Benralizumab Doses in Patients With Moderate to Very Severe COPD With Previous 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.

Conditions: Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Being tested: Benralizumab Arm A, Benralizumab Arm B, Benralizumab Arm C, 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
Benralizumab Arm CDrug
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
PlaceboDrug
Benralizumab subcutaneously on study week 0 until study week 48 inclusive

Study groups in NCT02155660
Study group	Role	What they receive
Benralizumab Arm A	Experimental	Benralizumab administered subcutaneously Receives: Drug: Benralizumab Arm A
Benralizumab Arm B	Experimental	Benralizumab administered subcutaneously Receives: Drug: Benralizumab Arm B
Benralizumab Arm C	Experimental	Benralizumab administered subcutaneously Receives: Drug: Benralizumab Arm C
Placebo	Placebo comparator	Placebo administered subcutaneously Receives: Drug: Placebo

What is being measured

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

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: Immediately following the first IP dose through week 56

Secondary outcomes (18)

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: Immediately following the first IP dose through week 56
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
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
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
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
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
Mean Change From Baseline in Proportion of Nights With Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL
Change from baseline to Week 56 in proportion of nights with awakenings due to respiratory symptoms.
Measured: First IP up to Week 56
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 considering their experiences "today". The daily EXACT-PRO total score is recorded and has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is calculated based on comparison of the baseline score with daily total scores. An increase of EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicates a COPD exacerbation event has occurred.
Measured: Immediately following first IP up to week 56
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 considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Severity of the study is the highest score of EXACT-PRO.
Measured: Immediately following first IP up to week 56
Duration of COPD Exacerbation Based on EXACT-PRO Score 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 considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is identified by comparing the baseline score 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. Event duration is calculated 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
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 considering 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 the first IP dose through week 56
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 dose up to week 56
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 IP dose to Week 56
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 the first IP dose through week 56
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 dose up to Week 56
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.
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).
Immunogenicity of Benralizumab
Anti-drug 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.

25 Jun 20149 Apr 2018

First posted4 Jun 2014 (estimated)
Study start25 Jun 2014
Primary completion9 Apr 2018
Study completion9 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Moderate to Very Severe 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: 2,255 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02155660
Sponsor's protocol ID: D3251C00004
Acronym: TERRANOVA
Status last verified: Jun 2019
First submitted: 20 May 2014
Last updated: 26 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
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

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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RecruitingPhase 3
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All Moderate to Very Severe Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Double Dummy, 56 Week Placebo-controlled, Multicentre, Parallel Group, Phase 3 Study Evaluating Efficacy/Safety of 3 Benralizumab Doses in Patients With Moderate to Very Severe COPD With Previous Exacerbations.
ClinicalTrials.gov ID: NCT02155660
Acronym / sponsor ID: TERRANOVA / D3251C00004
Conditions: Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Keywords: Obstructive Lung Diseases, Chronic Obstructive Pulmonary Disease, Lung Disease, Bronchial Diseases, COPD Exacerbation, Respiratory Tract Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,255 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: MedImmune LLC
Study start: 25 Jun 2014 (actual)
Primary completion: 9 Apr 2018 (actual)
Study completion: 9 Apr 2018 (actual)
First posted: 4 Jun 2014 (estimated)
Results: Posted 26 Jun 2019

Clinical summary

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

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Benralizumab Arm A	Experimental	Drug: Benralizumab Arm ABenralizumab administered subcutaneously
Benralizumab Arm B	Experimental	Drug: Benralizumab Arm BBenralizumab administered subcutaneously
Benralizumab Arm C	Experimental	Drug: Benralizumab Arm CBenralizumab administered subcutaneously
Placebo	Placebo comparator	Drug: PlaceboPlacebo administered subcutaneously

Who may qualify

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

Key inclusion criteria (11 listed)

Informed consent.
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.

Key exclusion criteria (17 listed)

Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
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.

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
Benralizumab Arm ABenralizumab subcutaneously on study week 0 until study week 48 inclusive	Drug	Benralizumab Arm A
Benralizumab Arm BBenralizumab subcutaneously on study week 0 until study week 48 inclusive	Drug	Benralizumab Arm B
Benralizumab Arm CBenralizumab subcutaneously on study week 0 until study week 48 inclusive	Drug	Benralizumab Arm C
PlaceboBenralizumab subcutaneously on study week 0 until study week 48 inclusive	Drug	Placebo

Primary outcome

Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
Time frame: Immediately following the first IP dose through week 56
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.

18 secondary outcomes

Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL
Time frame: Immediately following the first IP dose through week 56
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL
Time frame: First IP up to end of treatment Week 56
Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL
Time frame: First IP up to Week 56
Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL
Time frame: First IP up to Week 56
Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL
Time frame: First IP up to Week 56
Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL
Time frame: First IP up to Week 56
Mean Change From Baseline in Proportion of Nights With Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL
Time frame: First IP up to Week 56
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL
Time frame: Immediately following first IP up to week 56
Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL
Time frame: Immediately following first IP up to week 56
Duration of COPD Exacerbation Based on EXACT-PRO Score for Patients With Baseline EOS>=220/uL
Time frame: Immediately following first IP up to week 56
Annual EXACT-PRO Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
Time frame: Immediately following the first IP dose through week 56
Number of Participants Having at Least 1 COPD Exacerbation for Patients With Baseline EOS>=220/uL
Time frame: Immediately following first IP dose up to week 56
Time to First COPD Exacerbation
Time frame: Immediately following IP dose to Week 56
Annual COPD Exacerbation Rate Associated With ER or Hospitalization Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
Time frame: Immediately following the first IP dose through week 56
Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL
Time frame: Immediately following first IP dose up to Week 56
Duration of Study Treatment Administration
Time frame: From first dose date to last dose date, 48 weeks per protocol.
Serum Concentration of Benralizumab
Time frame: Pre-first dose and pre-dose at end of treatment (week 56).
Immunogenicity of Benralizumab
Time frame: Pre-treatment until end of follow-up, week 60 per protocol.

Results and safety

Results posted to the registry on 26 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Benralizumab 10 mg	562	504
Benralizumab 30 mg	562	489
Benralizumab 100 mg	562	502
Placebo	568	507

Primary outcome: Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL

Time frame: Immediately following the first IP dose through week 56. Least squares mean (95% Confidence Interval). Unit: Exacerbations per year

Measure	Benralizumab 10 mg n = 377	Benralizumab 30 mg n = 394	Benralizumab 100 mg n = 386	Placebo n = 388
Value	0.99 (0.87 to 1.13)	1.21 (1.08 to 1.37)	1.09 (0.96 to 1.23)	1.17 (1.04 to 1.32)

Benralizumab 10 mg vs Placebo: Rate ratio: 0.85 (95% CI 0.71 to 1.01), p = 0.0638, Negative binomial
Benralizumab 30 mg vs Placebo: Rate ratio: 1.04 (95% CI 0.88 to 1.23), p = 0.6575, Negative binomial
Benralizumab 100 mg vs Placebo: Rate ratio: 0.93 (95% CI 0.78 to 1.10), p = 0.3988, Negative binomial

Population analysed: Full analysis set, baseline EOS\>=220/uL

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Benra 10 mg	144 of 561 (25.7%)	251 of 561 (44.7%)	17 of 561
Benra 30 mg	177 of 563 (31.4%)	233 of 563 (41.4%)	21 of 563
Benra 100 mg	127 of 562 (22.6%)	238 of 562 (42.3%)	17 of 562
Placebo	158 of 568 (27.8%)	260 of 568 (45.8%)	19 of 568

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31575508Criner 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.
Derived from this study: PubMed 31112385Criner 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.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

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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.

Bartolome R. Celli, MD principal investigator

Brigham and Women's Hospital, Pulmonary Division, 75 Francis Street, PBB Clinics 3, Boston, MA 02115

356 sites in 26 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 17 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 26 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 356 sites in United States, Argentina, Poland, Ukraine, Bulgaria and 21 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 26 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: Immediately following the first IP dose through 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 NCT02155660, 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 26 Jun 2019.