Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02155660




Registration number
NCT02155660
Ethics application status
Date submitted
20/05/2014
Date registered
4/06/2014
Date last updated
26/06/2019

Titles & IDs
Public title
Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History
Scientific 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.
Secondary ID [1] 0 0
D3251C00004
Universal Trial Number (UTN)
Trial acronym
TERRANOVA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to Very Severe Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Benralizumab Arm A
Treatment: Drugs - Benralizumab Arm B
Treatment: Drugs - Benralizumab Arm C
Treatment: Drugs - Placebo

Experimental: Benralizumab Arm A - Benralizumab administered subcutaneously

Experimental: Benralizumab Arm B - Benralizumab administered subcutaneously

Experimental: Benralizumab Arm C - Benralizumab administered subcutaneously

Placebo comparator: Placebo - Placebo administered subcutaneously


Treatment: Drugs: Benralizumab Arm A
Benralizumab subcutaneously on study week 0 until study week 48 inclusive

Treatment: Drugs: Benralizumab Arm B
Benralizumab subcutaneously on study week 0 until study week 48 inclusive

Treatment: Drugs: Benralizumab Arm C
Benralizumab subcutaneously on study week 0 until study week 48 inclusive

Treatment: Drugs: Placebo
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
Timepoint [1] 0 0
Immediately following the first IP dose through week 56
Secondary outcome [1] 0 0
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL
Timepoint [1] 0 0
Immediately following the first IP dose through week 56
Secondary outcome [2] 0 0
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL
Timepoint [2] 0 0
First IP up to end of treatment Week 56
Secondary outcome [3] 0 0
Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL
Timepoint [3] 0 0
First IP up to Week 56
Secondary outcome [4] 0 0
Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL
Timepoint [4] 0 0
First IP up to Week 56
Secondary outcome [5] 0 0
Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL
Timepoint [5] 0 0
First IP up to Week 56
Secondary outcome [6] 0 0
Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL
Timepoint [6] 0 0
First IP up to Week 56
Secondary outcome [7] 0 0
Mean Change From Baseline in Proportion of Nights With Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL
Timepoint [7] 0 0
First IP up to Week 56
Secondary outcome [8] 0 0
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL
Timepoint [8] 0 0
Immediately following first IP up to week 56
Secondary outcome [9] 0 0
Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL
Timepoint [9] 0 0
Immediately following first IP up to week 56
Secondary outcome [10] 0 0
Duration of COPD Exacerbation Based on EXACT-PRO Score for Patients With Baseline EOS>=220/uL
Timepoint [10] 0 0
Immediately following first IP up to week 56
Secondary outcome [11] 0 0
Annual EXACT-PRO Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
Timepoint [11] 0 0
Immediately following the first IP dose through week 56
Secondary outcome [12] 0 0
Number of Participants Having at Least 1 COPD Exacerbation for Patients With Baseline EOS>=220/uL
Timepoint [12] 0 0
Immediately following first IP dose up to week 56
Secondary outcome [13] 0 0
Time to First COPD Exacerbation
Timepoint [13] 0 0
Immediately following IP dose to Week 56
Secondary outcome [14] 0 0
Annual COPD Exacerbation Rate Associated With ER or Hospitalization Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
Timepoint [14] 0 0
Immediately following the first IP dose through week 56
Secondary outcome [15] 0 0
Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL
Timepoint [15] 0 0
Immediately following first IP dose up to Week 56
Secondary outcome [16] 0 0
Duration of Study Treatment Administration
Timepoint [16] 0 0
From first dose date to last dose date, 48 weeks per protocol.
Secondary outcome [17] 0 0
Serum Concentration of Benralizumab
Timepoint [17] 0 0
Pre-first dose and pre-dose at end of treatment (week 56).
Secondary outcome [18] 0 0
Immunogenicity of Benralizumab
Timepoint [18] 0 0
Pre-treatment until end of follow-up, week 60 per protocol.

Eligibility
Key inclusion criteria
.

* 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.
* 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.
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* 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.
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/04/2018
Sample size
Target
Accrual to date
Final
2255
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Clayton
Recruitment hospital [2] 0 0
Research Site - Gosford
Recruitment hospital [3] 0 0
Research Site - Murdoch
Recruitment hospital [4] 0 0
Research Site - Nedlands
Recruitment hospital [5] 0 0
Research Site - New Lambton
Recruitment hospital [6] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
2310 - New Lambton
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maine
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Montana
Country [20] 0 0
United States of America
State/province [20] 0 0
Nebraska
Country [21] 0 0
United States of America
State/province [21] 0 0
Nevada
Country [22] 0 0
United States of America
State/province [22] 0 0
New Jersey
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oklahoma
Country [27] 0 0
United States of America
State/province [27] 0 0
Oregon
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
South Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
South Dakota
Country [31] 0 0
United States of America
State/province [31] 0 0
Tennessee
Country [32] 0 0
United States of America
State/province [32] 0 0
Texas
Country [33] 0 0
United States of America
State/province [33] 0 0
Utah
Country [34] 0 0
United States of America
State/province [34] 0 0
Virginia
Country [35] 0 0
United States of America
State/province [35] 0 0
Washington
Country [36] 0 0
United States of America
State/province [36] 0 0
West Virginia
Country [37] 0 0
Argentina
State/province [37] 0 0
Buenos Aires
Country [38] 0 0
Argentina
State/province [38] 0 0
Caba
Country [39] 0 0
Argentina
State/province [39] 0 0
Ciudad Autónoma de Buenos Aire
Country [40] 0 0
Argentina
State/province [40] 0 0
Ciudad de Buenos Aires
Country [41] 0 0
Argentina
State/province [41] 0 0
Concepción del Uruguay
Country [42] 0 0
Argentina
State/province [42] 0 0
Corrientes
Country [43] 0 0
Argentina
State/province [43] 0 0
Córdoba
Country [44] 0 0
Argentina
State/province [44] 0 0
Florencio Varela
Country [45] 0 0
Argentina
State/province [45] 0 0
Florida
Country [46] 0 0
Argentina
State/province [46] 0 0
Mar del Plata
Country [47] 0 0
Argentina
State/province [47] 0 0
Mendoza
Country [48] 0 0
Argentina
State/province [48] 0 0
Nueve de julio
Country [49] 0 0
Argentina
State/province [49] 0 0
Quilmes
Country [50] 0 0
Argentina
State/province [50] 0 0
Rosario
Country [51] 0 0
Argentina
State/province [51] 0 0
San Fernando
Country [52] 0 0
Argentina
State/province [52] 0 0
San Miguel de Tucuman
Country [53] 0 0
Belgium
State/province [53] 0 0
Brussels
Country [54] 0 0
Belgium
State/province [54] 0 0
Genk
Country [55] 0 0
Belgium
State/province [55] 0 0
Jambes
Country [56] 0 0
Belgium
State/province [56] 0 0
Leuven
Country [57] 0 0
Belgium
State/province [57] 0 0
Malmedy
Country [58] 0 0
Belgium
State/province [58] 0 0
Turnhout
Country [59] 0 0
Belgium
State/province [59] 0 0
Veurne
Country [60] 0 0
Brazil
State/province [60] 0 0
Fortaleza
Country [61] 0 0
Brazil
State/province [61] 0 0
Porto Alegre
Country [62] 0 0
Brazil
State/province [62] 0 0
Rio de Janeiro
Country [63] 0 0
Brazil
State/province [63] 0 0
Santo Andre
Country [64] 0 0
Brazil
State/province [64] 0 0
Sao Paulo
Country [65] 0 0
Brazil
State/province [65] 0 0
Sorocaba
Country [66] 0 0
Brazil
State/province [66] 0 0
Vitória
Country [67] 0 0
Bulgaria
State/province [67] 0 0
Dupnitsa
Country [68] 0 0
Bulgaria
State/province [68] 0 0
Kozloduy
Country [69] 0 0
Bulgaria
State/province [69] 0 0
Pazardzhik
Country [70] 0 0
Bulgaria
State/province [70] 0 0
Pernik
Country [71] 0 0
Bulgaria
State/province [71] 0 0
Petrich
Country [72] 0 0
Bulgaria
State/province [72] 0 0
Plovdiv
Country [73] 0 0
Bulgaria
State/province [73] 0 0
Ruse
Country [74] 0 0
Bulgaria
State/province [74] 0 0
Sandanski
Country [75] 0 0
Bulgaria
State/province [75] 0 0
Silistra
Country [76] 0 0
Bulgaria
State/province [76] 0 0
Sofia
Country [77] 0 0
Bulgaria
State/province [77] 0 0
Vidin
Country [78] 0 0
Bulgaria
State/province [78] 0 0
Vratsa
Country [79] 0 0
Bulgaria
State/province [79] 0 0
Yambol
Country [80] 0 0
Chile
State/province [80] 0 0
Curico
Country [81] 0 0
Chile
State/province [81] 0 0
Quillota
Country [82] 0 0
Chile
State/province [82] 0 0
Santiago
Country [83] 0 0
Chile
State/province [83] 0 0
Talca
Country [84] 0 0
Colombia
State/province [84] 0 0
Armenia
Country [85] 0 0
Colombia
State/province [85] 0 0
Barranquilla
Country [86] 0 0
Colombia
State/province [86] 0 0
Bogota
Country [87] 0 0
Colombia
State/province [87] 0 0
Bogotá
Country [88] 0 0
Colombia
State/province [88] 0 0
Cali
Country [89] 0 0
Colombia
State/province [89] 0 0
Manizales
Country [90] 0 0
Colombia
State/province [90] 0 0
Medellin
Country [91] 0 0
Colombia
State/province [91] 0 0
Medillin
Country [92] 0 0
Croatia
State/province [92] 0 0
Petrinja
Country [93] 0 0
Denmark
State/province [93] 0 0
Aarhus N
Country [94] 0 0
Denmark
State/province [94] 0 0
København NV
Country [95] 0 0
Denmark
State/province [95] 0 0
Næstved
Country [96] 0 0
Denmark
State/province [96] 0 0
Odense C
Country [97] 0 0
Denmark
State/province [97] 0 0
Roskilde
Country [98] 0 0
Denmark
State/province [98] 0 0
Silkeborg
Country [99] 0 0
France
State/province [99] 0 0
Bois Guillaume
Country [100] 0 0
France
State/province [100] 0 0
Brest Cedex
Country [101] 0 0
France
State/province [101] 0 0
La Tronche
Country [102] 0 0
France
State/province [102] 0 0
Lille cedex
Country [103] 0 0
France
State/province [103] 0 0
Lyon Cedex 04
Country [104] 0 0
France
State/province [104] 0 0
Marseille
Country [105] 0 0
France
State/province [105] 0 0
Montpellier
Country [106] 0 0
France
State/province [106] 0 0
NIMES Cedex 9
Country [107] 0 0
France
State/province [107] 0 0
Orléans Cedex 2
Country [108] 0 0
France
State/province [108] 0 0
Pessac
Country [109] 0 0
Israel
State/province [109] 0 0
Haifa
Country [110] 0 0
Israel
State/province [110] 0 0
Jerusalem
Country [111] 0 0
Israel
State/province [111] 0 0
Petach Tikva
Country [112] 0 0
Israel
State/province [112] 0 0
Rehovot
Country [113] 0 0
Israel
State/province [113] 0 0
Tel Aviv
Country [114] 0 0
Mexico
State/province [114] 0 0
Durango
Country [115] 0 0
Mexico
State/province [115] 0 0
Guadalajara
Country [116] 0 0
Mexico
State/province [116] 0 0
Mexico
Country [117] 0 0
Mexico
State/province [117] 0 0
Monterrey
Country [118] 0 0
New Zealand
State/province [118] 0 0
Auckland
Country [119] 0 0
New Zealand
State/province [119] 0 0
Dunedin
Country [120] 0 0
New Zealand
State/province [120] 0 0
Greenlane
Country [121] 0 0
New Zealand
State/province [121] 0 0
Hamilton West
Country [122] 0 0
New Zealand
State/province [122] 0 0
Tauranga
Country [123] 0 0
Norway
State/province [123] 0 0
Bodø
Country [124] 0 0
Norway
State/province [124] 0 0
Kolbjørnsvik
Country [125] 0 0
Norway
State/province [125] 0 0
Svelvik
Country [126] 0 0
Peru
State/province [126] 0 0
Cusco
Country [127] 0 0
Peru
State/province [127] 0 0
Lima
Country [128] 0 0
Peru
State/province [128] 0 0
Piura
Country [129] 0 0
Philippines
State/province [129] 0 0
Iloilo City
Country [130] 0 0
Philippines
State/province [130] 0 0
Lipa City
Country [131] 0 0
Philippines
State/province [131] 0 0
Manila
Country [132] 0 0
Philippines
State/province [132] 0 0
Quezon City
Country [133] 0 0
Poland
State/province [133] 0 0
Bialystok
Country [134] 0 0
Poland
State/province [134] 0 0
Bydgoszcz
Country [135] 0 0
Poland
State/province [135] 0 0
Gdansk
Country [136] 0 0
Poland
State/province [136] 0 0
Gorzów Wlkp
Country [137] 0 0
Poland
State/province [137] 0 0
Grodzisk Mazowiecki
Country [138] 0 0
Poland
State/province [138] 0 0
Karczew
Country [139] 0 0
Poland
State/province [139] 0 0
Katowice
Country [140] 0 0
Poland
State/province [140] 0 0
Kraków
Country [141] 0 0
Poland
State/province [141] 0 0
Ostrowiec Swietokrzyski
Country [142] 0 0
Poland
State/province [142] 0 0
Ostrów Wielkopolski
Country [143] 0 0
Poland
State/province [143] 0 0
Ruda Slaska
Country [144] 0 0
Poland
State/province [144] 0 0
Skierniewice
Country [145] 0 0
Poland
State/province [145] 0 0
Sosnowiec
Country [146] 0 0
Poland
State/province [146] 0 0
Starachowice
Country [147] 0 0
Poland
State/province [147] 0 0
Szczecin
Country [148] 0 0
Poland
State/province [148] 0 0
Slupca
Country [149] 0 0
Poland
State/province [149] 0 0
Trzebnica
Country [150] 0 0
Poland
State/province [150] 0 0
Wroclaw
Country [151] 0 0
Poland
State/province [151] 0 0
Znin
Country [152] 0 0
Serbia
State/province [152] 0 0
Belgrade
Country [153] 0 0
Slovenia
State/province [153] 0 0
Celje
Country [154] 0 0
Slovenia
State/province [154] 0 0
Golnik
Country [155] 0 0
Slovenia
State/province [155] 0 0
Kamnik
Country [156] 0 0
Slovenia
State/province [156] 0 0
Ljubljana
Country [157] 0 0
Slovenia
State/province [157] 0 0
Maribor
Country [158] 0 0
Sweden
State/province [158] 0 0
Goteborg
Country [159] 0 0
Sweden
State/province [159] 0 0
Göteborg
Country [160] 0 0
Sweden
State/province [160] 0 0
Helsingborg
Country [161] 0 0
Sweden
State/province [161] 0 0
Lund
Country [162] 0 0
Sweden
State/province [162] 0 0
Malmo
Country [163] 0 0
Sweden
State/province [163] 0 0
Stockholm
Country [164] 0 0
Sweden
State/province [164] 0 0
Uppsala
Country [165] 0 0
Taiwan
State/province [165] 0 0
Changhua
Country [166] 0 0
Taiwan
State/province [166] 0 0
Kaohsiung
Country [167] 0 0
Taiwan
State/province [167] 0 0
New-Taipei
Country [168] 0 0
Taiwan
State/province [168] 0 0
Taichung
Country [169] 0 0
Taiwan
State/province [169] 0 0
Taipei
Country [170] 0 0
Thailand
State/province [170] 0 0
Bangkoknoi
Country [171] 0 0
Thailand
State/province [171] 0 0
Bangkok
Country [172] 0 0
Thailand
State/province [172] 0 0
Hat Yai
Country [173] 0 0
Thailand
State/province [173] 0 0
Khon Kaen
Country [174] 0 0
Thailand
State/province [174] 0 0
Muang,
Country [175] 0 0
Thailand
State/province [175] 0 0
Nonthaburi
Country [176] 0 0
Turkey
State/province [176] 0 0
Adana
Country [177] 0 0
Turkey
State/province [177] 0 0
Ankara
Country [178] 0 0
Turkey
State/province [178] 0 0
Bursa
Country [179] 0 0
Turkey
State/province [179] 0 0
Istanbul
Country [180] 0 0
Turkey
State/province [180] 0 0
Izmir
Country [181] 0 0
Turkey
State/province [181] 0 0
Mersin
Country [182] 0 0
Ukraine
State/province [182] 0 0
Cherkasy
Country [183] 0 0
Ukraine
State/province [183] 0 0
Chernivtsi
Country [184] 0 0
Ukraine
State/province [184] 0 0
Dnipropetrovsk
Country [185] 0 0
Ukraine
State/province [185] 0 0
Ivano-Frankivsk
Country [186] 0 0
Ukraine
State/province [186] 0 0
Kharkiv
Country [187] 0 0
Ukraine
State/province [187] 0 0
Kyiv
Country [188] 0 0
Ukraine
State/province [188] 0 0
Lutsk
Country [189] 0 0
Ukraine
State/province [189] 0 0
Lviv
Country [190] 0 0
Ukraine
State/province [190] 0 0
Odesa
Country [191] 0 0
Ukraine
State/province [191] 0 0
Vinnytsia
Country [192] 0 0
Ukraine
State/province [192] 0 0
Zaporizhzhya
Country [193] 0 0
Vietnam
State/province [193] 0 0
Can Tho
Country [194] 0 0
Vietnam
State/province [194] 0 0
Hanoi
Country [195] 0 0
Vietnam
State/province [195] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
MedImmune LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bartolome R. Celli, MD
Address 0 0
Brigham and Women's Hospital, Pulmonary Division, 75 Francis Street, PBB Clinics 3, Boston, MA 02115
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02155660