A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA (BORA)

August 5, 2019 updated by: AstraZeneca

A Multicentre, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting β2 Agonist (BORA)

The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.

Study Overview

Status

Completed

Conditions

Asthma

Intervention / Treatment

Biological: Benralizumab

Detailed Description

After a minimum of 1200 patients have been enrolled in this study, subsequent patients (up to a maximum of 2200 total for the study), who complete a minimum of 16 weeks, and no more than 40 weeks, in this study, will be given the option to transition to an open-label safety extension study, Study D3250C00037 (MELTEMI).

Adolescent patients, patients from Japan and South Korea, and any patient who chooses not to enter Study D3250C00037 will remain in this study through IPD or EOT and FU.

At the time of the first interim analysis in Japanese patients, the study regimen for all patients will become unblinded to AstraZeneca for data analysis purposes. Study conduct and blinding at the site and patient level will remain unchanged.

Study Type

Interventional

Enrollment (Actual)

2133

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1414AIF
    - Research Site
  - Buenos Aires, Argentina, 1121
    - Research Site
  - Caba, Argentina, C1425BEN
    - Research Site
  - Caba, Argentina, C1056ABJ
    - Research Site
  - Caba, Argentina, C1431FWO
    - Research Site
  - Ciudad Autónoma de Bs. As., Argentina, 1426
    - Research Site
  - Concepción del Uruguay, Argentina, 3260
    - Research Site
  - Corrientes, Argentina, 3400
    - Research Site
  - Córdoba, Argentina, X5003DCE
    - Research Site
  - Florida, Argentina, 1138
    - Research Site
  - Godoy Cruz, Argentina
    - Research Site
  - La Plata, Argentina, B1902COS
    - Research Site
  - Mar del Plata, Argentina, B7600GNY
    - Research Site
  - Mendoza, Argentina, 5500
    - Research Site
  - Mendoza, Argentina, M5500GIP
    - Research Site
  - Nueve de julio, Argentina, B6500EZL
    - Research Site
  - Ranelagh, Argentina, 1886
    - Research Site
  - Rosario, Argentina, S2000DEJ
    - Research Site
  - San Miguel de Tucuman, Argentina, 4000
    - Research Site
Australia
- - Bedford Park, Australia, 5042
    - Research Site
  - Box Hill, Australia, 3128
    - Research Site
  - Clayton, Australia, 3168
    - Research Site
  - Concord, Australia, 2139
    - Research Site
  - Frankston, Australia, 3199
    - Research Site
  - Nedlands, Australia, 6009
    - Research Site
  - New Lambton Heights, Australia, 2305
    - Research Site
  - Parkville, Australia, 3050
    - Research Site
  - Prahran, Australia, 3004
    - Research Site
  - Randwick, Australia, 2031
    - Research Site
  - Woolloongabba, Australia, 4102
    - Research Site
Brazil
- - Porto Alegre, Brazil, 90610-000
    - Research Site
  - Porto Alegre, Brazil, 91350-200
    - Research Site
  - Porto Alegre, Brazil, 90035074
    - Research Site
  - Santo Andre, Brazil, 09080-110
    - Research Site
  - Sao Paulo, Brazil, 05403-000
    - Research Site
  - Sorocaba, Brazil, 18040-425
    - Research Site
  - São Paulo, Brazil, 04323-062
    - Research Site
Bulgaria
- - Dupnitsa, Bulgaria, 2600
    - Research Site
  - Pazardzhik, Bulgaria, 4400
    - Research Site
  - Pernik, Bulgaria, 2300
    - Research Site
  - Petrich, Bulgaria, 2850
    - Research Site
  - Pleven, Bulgaria, 5800
    - Research Site
  - Ruse, Bulgaria, 7002
    - Research Site
  - Samokov, Bulgaria, 2000
    - Research Site
  - Sliven, Bulgaria, 8800
    - Research Site
  - Sofia, Bulgaria, 1002
    - Research Site
  - Sofia, Bulgaria, 1152
    - Research Site
  - Stara Zagora, Bulgaria, 6003
    - Research Site
  - Varna, Bulgaria, 9000
    - Research Site
  - Velingrad, Bulgaria, 4600
    - Research Site
  - Vratsa, Bulgaria, 3000
    - Research Site
  - Yambol, Bulgaria, 8600
    - Research Site
Canada
- - Quebec, Canada, G1G 3Y8
    - Research Site
  - Quebec, Canada, G1V 4G5
    - Research Site
- Alberta
  - Calgary, Alberta, Canada, T2N 4Z6
    - Research Site
  - Sherwood Park, Alberta, Canada, T8L 0N2
    - Research Site
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - Research Site
  - Vancouver, British Columbia, Canada, V6Z 1Y6
    - Research Site
- Ontario
  - Burlington, Ontario, Canada, L7N 3V2
    - Research Site
  - Hamilton, Ontario, Canada, L8N 4A6
    - Research Site
  - Ottawa, Ontario, Canada, K1G 6C6
    - Research Site
- Quebec
  - Montreal, Quebec, Canada, H4A 3J1
    - Research Site
  - Montreal, Quebec, Canada, H4J 1C5
    - Research Site
  - Montreal, Quebec, Canada, H2W 1T8
    - Research Site
  - St Charles Borromee, Quebec, Canada, J6E 2B4
    - Research Site
Chile
- - Quillota, Chile, 2260000
    - Research Site
  - Santiago, Chile, 8207257
    - Research Site
  - Talcahuano, Chile, 4270918
    - Research Site
  - Valparaiso, Chile, 2341131
    - Research Site
  - Viña del Mar, Chile, 2520594
    - Research Site
Czechia
- - Jindrichuv Hradec, Czechia, 377 01
    - Research Site
  - Karlovy Vary, Czechia, 360 17
    - Research Site
  - Ostrava, Czechia, 728 80
    - Research Site
  - Plzen, Czechia, 30460
    - Research Site
  - Praha, Czechia, 130 00
    - Research Site
  - Rokycany, Czechia, 337 22
    - Research Site
  - Strakonice, Czechia, 38601
    - Research Site
  - Teplice, Czechia, 415 01
    - Research Site
France
- - Brest Cedex, France, 29609
    - Research Site
  - Dijon Cedex, France, 21079
    - Research Site
  - Le Kremlin Bicêtre, France, 94275
    - Research Site
  - Le Mans Cedex, France, 72037
    - Research Site
  - Lyon Cedex 4, France, 69317
    - Research Site
  - Marseille, France, 13015
    - Research Site
  - Montpellier, France, 34295
    - Research Site
  - Paris, France, 75018
    - Research Site
  - Pau Cedex, France, 64046
    - Research Site
  - Pringy Cedex, France, 74374
    - Research Site
  - Saint Pierre, France, 97448
    - Research Site
  - Strasbourg Cedex, France, 67091
    - Research Site
  - Toulouse CEDEX 09, France, 31059
    - Research Site
Germany
- - Aschaffenburg, Germany, 63739
    - Research Site
  - Bamberg, Germany, 96049
    - Research Site
  - Berlin, Germany, 10367
    - Research Site
  - Berlin, Germany, 10717
    - Research Site
  - Berlin, Germany, 10787
    - Research Site
  - Berlin, Germany, 12203
    - Research Site
  - Bonn, Germany, 53123
    - Research Site
  - Frankfurt, Germany, 60596
    - Research Site
  - Frankfurt am Main, Germany, 60596
    - Research Site
  - Frankfurt/Main, Germany, 60389
    - Research Site
  - Geesthacht, Germany, 21502
    - Research Site
  - Grosshansdorf, Germany, 22927
    - Research Site
  - Hamburg, Germany, 22299
    - Research Site
  - Hannover, Germany, 30625
    - Research Site
  - Hannover, Germany, D-30173
    - Research Site
  - Hannover, Germany, 30167
    - Research Site
  - Herford, Germany, 32049
    - Research Site
  - Leipzig, Germany, 04103
    - Research Site
  - Leipzig, Germany, 04207
    - Research Site
  - Leipzig, Germany, 04275
    - Research Site
  - Mainz Am Rhein, Germany, 55131
    - Research Site
  - München, Germany, 80639
    - Research Site
  - München, Germany, 80539
    - Research Site
  - Neu-Isenburg, Germany, 63263
    - Research Site
  - Rostock, Germany, 18057
    - Research Site
  - Rüdersdorf, Germany, 15562
    - Research Site
  - Witten, Germany, 58452
    - Research Site
Japan
- - Asahi-shi, Japan, 289-2511
    - Research Site
  - Chiyoda-ku, Japan, 102-0083
    - Research Site
  - Chuo-ku, Japan, 103-0022
    - Research Site
  - Fukuoka-shi, Japan, 811-1394
    - Research Site
  - Hiroshima-shi, Japan, 732-0052
    - Research Site
  - Itabashi-ku, Japan, 173-8610
    - Research Site
  - Itabashi-ku, Japan, 174-0065
    - Research Site
  - Kagoshima-shi, Japan, 890-0064
    - Research Site
  - Kishiwada-shi, Japan, 596-8501
    - Research Site
  - Kobe-shi, Japan, 653-0013
    - Research Site
  - Kokubunji-shi, Japan, 185-0014
    - Research Site
  - Matsue-shi, Japan, 690-8556
    - Research Site
  - Minato-ku, Japan, 105-0003
    - Research Site
  - Mizunami-shi, Japan, 509-6134
    - Research Site
  - Niigata-shi, Japan, 950-2085
    - Research Site
  - Obihiro-shi, Japan, 080-0013
    - Research Site
  - Oita-shi, Japan, 870-0021
    - Research Site
  - Ota-shi, Japan, 373-0807
    - Research Site
  - Sagamihara-shi, Japan, 252-0315
    - Research Site
  - Sakai-shi, Japan, 591-8037
    - Research Site
  - Sakaide-shi, Japan, 762-8550
    - Research Site
  - Sapporo-shi, Japan, 060-0033
    - Research Site
  - Sapporo-shi, Japan, 064-0807
    - Research Site
  - Sendai-shi, Japan, 983-8520
    - Research Site
  - Setagaya-ku, Japan, 158-0097
    - Research Site
  - Shibuya-ku, Japan, 150-0013
    - Research Site
  - Shinagawa-ku, Japan, 142-8666
    - Research Site
  - Sumida-ku, Japan, 130-8587
    - Research Site
  - Takamatsu-shi, Japan, 761-7073
    - Research Site
  - Toshima-ku, Japan, 170-0003
    - Research Site
  - Tsukubo-gun, Japan, 701-0304
    - Research Site
  - Yokohama-shi, Japan, 236-0024
    - Research Site
  - Yokohama-shi, Japan, 231-8682
    - Research Site
  - Yokohama-shi, Japan, 234-0054
    - Research Site
Korea, Republic of
- - Anyang-si, Korea, Republic of, 14068
    - Research Site
  - Bucheon-si, Korea, Republic of, 14584
    - Research Site
  - Busan, Korea, Republic of, 49201
    - Research Site
  - Busan, Korea, Republic of, 602-702
    - Research Site
  - Cheongju-si, Korea, Republic of, 362-804
    - Research Site
  - Gwangju, Korea, Republic of, 61469
    - Research Site
  - Incheon, Korea, Republic of, 21431
    - Research Site
  - Incheon, Korea, Republic of, 405-760
    - Research Site
  - Jeju-si, Korea, Republic of, 690-767
    - Research Site
  - Seoul, Korea, Republic of, 03722
    - Research Site
  - Seoul, Korea, Republic of, 05505
    - Research Site
  - Seoul, Korea, Republic of, 03080
    - Research Site
  - Seoul, Korea, Republic of, 135-710
    - Research Site
  - Seoul, Korea, Republic of, 06591
    - Research Site
  - Seoul, Korea, Republic of, 03312
    - Research Site
  - Seoul, Korea, Republic of, 08308
    - Research Site
  - Seoul, Korea, Republic of, 150-713
    - Research Site
  - Seoul, Korea, Republic of, 07985
    - Research Site
  - Seoul, Korea, Republic of, 05030
    - Research Site
  - Suwon-si, Korea, Republic of, 16499
    - Research Site
Peru
- - Cusco, Peru
    - Research Site
  - Lima, Peru, LIMA 27
    - Research Site
  - Lima, Peru, LIMA 1
    - Research Site
  - Lima, Peru, Lima 18
    - Research Site
  - Lima, Peru, 41
    - Research Site
  - Lima, Peru, LIMA 33
    - Research Site
  - Lima, Peru, L41
    - Research Site
  - Lima, Peru, 15102
    - Research Site
  - Lima, Peru, LIMA 21
    - Research Site
Philippines
- - Iloilo City, Philippines, 5000
    - Research Site
  - Lipa City, Philippines, 4217
    - Research Site
  - Quezon City, Philippines, 1101
    - Research Site
Poland
- - Aleksandrów Łódzki, Poland, 95-070
    - Research Site
  - Białystok, Poland, 15-044
    - Research Site
  - Białystok, Poland, 15-430
    - Research Site
  - Białystok, Poland, 15-879
    - Research Site
  - Białystok, Poland, 15-276
    - Research Site
  - Bielsko Biala, Poland, 43-316
    - Research Site
  - Bydgoszcz, Poland, 85-168
    - Research Site
  - Bystra Śląska, Poland, 43-360
    - Research Site
  - Dobre Miasto, Poland, 11-040
    - Research Site
  - Gdańsk, Poland, 80-952
    - Research Site
  - Gdańsk, Poland, 80-433
    - Research Site
  - Giżycko, Poland, 11-500
    - Research Site
  - Gorzów Wlkp, Poland, 66-400
    - Research Site
  - Grodzisk Mazowiecki, Poland, 05-825
    - Research Site
  - Karczew, Poland, 05-480
    - Research Site
  - Katowice, Poland, 40-081
    - Research Site
  - Koszalin, Poland, 75-679
    - Research Site
  - Kościan, Poland, 64-000
    - Research Site
  - Kraków, Poland, 31-159
    - Research Site
  - Kraków, Poland, 31-011
    - Research Site
  - Kraków, Poland, 31-033
    - Research Site
  - Kraków, Poland, 31-455
    - Research Site
  - Lubin, Poland, 59-300
    - Research Site
  - Lublin, Poland, 20-718
    - Research Site
  - Lublin, Poland, 20-552
    - Research Site
  - Lublin, Poland, 20-089
    - Research Site
  - Ostrów Wielkopolski, Poland, 63-400
    - Research Site
  - Poznań, Poland, 60-685
    - Research Site
  - Poznań, Poland, 60-693
    - Research Site
  - Poznań, Poland, 60-823
    - Research Site
  - Poznań, Poland, 60-214
    - Research Site
  - Proszowice, Poland, 32-100
    - Research Site
  - Ruda Slaska, Poland, 41-709
    - Research Site
  - Rzeszów, Poland, 35-205
    - Research Site
  - Rzeszów, Poland, 35-612
    - Research Site
  - Skierniewice, Poland, 96-100
    - Research Site
  - Sosnowiec, Poland, 41-200
    - Research Site
  - Szczecin, Poland, 70-111
    - Research Site
  - Tarnów, Poland, 33-100
    - Research Site
  - Trzebnica, Poland, 55-100
    - Research Site
  - Warszawa, Poland, 01-138
    - Research Site
  - Warszawa, Poland, 01-868
    - Research Site
  - Wieluń, Poland, 98-300
    - Research Site
  - Wołomin, Poland, 05-200
    - Research Site
  - Wroclaw, Poland, 53-201
    - Research Site
  - Wrocław, Poland, 53-301
    - Research Site
  - Wrocław, Poland, 50-220
    - Research Site
  - Wrocław, Poland, 51-162
    - Research Site
  - Łódź, Poland, 90-141
    - Research Site
  - Łódź, Poland, 90-242
    - Research Site
  - Łódź, Poland, 91-103
    - Research Site
  - Żnin, Poland, 88-400
    - Research Site
Romania
- - Bragadiru, Romania, 077025
    - Research Site
  - Bucharest, Romania, 030303
    - Research Site
  - Bucharest, Romania, 71593
    - Research Site
  - Constanta, Romania, 900002
    - Research Site
  - Deva, Romania, 330061
    - Research Site
  - Iasi, Romania, 700115
    - Research Site
Russian Federation
- - Chelyabinsk, Russian Federation, 454106
    - Research Site
  - Ekaterinburg, Russian Federation, 620039
    - Research Site
  - Ekaterinburg, Russian Federation, 620109
    - Research Site
  - Ivanovo, Russian Federation, 153005
    - Research Site
  - Izhevsk, Russian Federation, 426063
    - Research Site
  - Kazan, Russian Federation, 420012
    - Research Site
  - Moscow, Russian Federation, 123995
    - Research Site
  - Moscow, Russian Federation, 115682
    - Research Site
  - Moscow, Russian Federation, 121309
    - Research Site
  - Moscow, Russian Federation, 109240
    - Research Site
  - Nizhny Novgorod, Russian Federation, 603126
    - Research Site
  - Novosibirsk, Russian Federation, 630008
    - Research Site
  - Novosibirsk, Russian Federation, 630084
    - Research Site
  - Pyatigorsk, Russian Federation, 357500
    - Research Site
  - Ryazan, Russian Federation, 390026
    - Research Site
  - Saint - Petersburg, Russian Federation, 196657
    - Research Site
  - Saint Petersburg, Russian Federation, 194354
    - Research Site
  - Saint Petersburg, Russian Federation, 195257
    - Research Site
  - Saint Petersburg, Russian Federation, 196084
    - Research Site
  - Saint-Petersburg, Russian Federation, 196084
    - Research Site
  - Saratov, Russian Federation, 410053
    - Research Site
  - Smolensk, Russian Federation, 214019
    - Research Site
  - St. Petersburg, Russian Federation, 196247
    - Research Site
  - St. Petersburg, Russian Federation, 197022
    - Research Site
  - St. Petersburg, Russian Federation, 194356
    - Research Site
  - St.Petersburg, Russian Federation, 194354
    - Research Site
  - StPetersburg, Russian Federation, 193312
    - Research Site
  - Tomsk, Russian Federation, 634063
    - Research Site
  - Vladikavkaz, Russian Federation, 362007
    - Research Site
  - Vladimir, Russian Federation, 600023
    - Research Site
  - Volgograd, Russian Federation, 400001
    - Research Site
  - Volgograd, Russian Federation, 400131
    - Research Site
  - Yekaterinburg, Russian Federation, 620149
    - Research Site
South Africa
- - Cape Town, South Africa, 7764
    - Research Site
  - Durban, South Africa, 4092
    - Research Site
  - Mowbray, South Africa, 7700
    - Research Site
  - Stanger, South Africa, 4450
    - Research Site
Spain
- - Barcelona, Spain, 08036
    - Research Site
  - Barcelona, Spain, 08025
    - Research Site
  - Lugo, Spain, 27004
    - Research Site
  - Madrid, Spain, 28040
    - Research Site
  - Málaga, Spain, 29010
    - Research Site
  - Oviedo, Spain, 33011
    - Research Site
  - Palma de Mallorca, Spain, 07010
    - Research Site
  - Sagunto(Valencia), Spain, 46520
    - Research Site
  - Salamanca, Spain, 37007
    - Research Site
  - Valencia, Spain, 46017
    - Research Site
  - Valencia, Spain, 46015
    - Research Site
Sweden
- - Göteborg, Sweden
    - Research Site
  - Lund, Sweden, 22185
    - Research Site
Turkey
- - Adana, Turkey, 01330
    - Research Site
  - Ankara, Turkey, 06230
    - Research Site
  - Bursa, Turkey, 16059
    - Research Site
  - Istanbul, Turkey, 34098
    - Research Site
  - Izmir, Turkey, 35100
    - Research Site
  - Mersin, Turkey, 33343
    - Research Site
  - İstanbul, Turkey, 34844
    - Research Site
Ukraine
- - Chernivtsi, Ukraine, 58000
    - Research Site
  - Dnipropetrovsk, Ukraine, 49007
    - Research Site
  - Ivano-Frankivsk, Ukraine, 76012
    - Research Site
  - Kharkiv, Ukraine, 61039
    - Research Site
  - Kharkiv, Ukraine, 61058
    - Research Site
  - Kharkiv, Ukraine, 61106
    - Research Site
  - Kharkiv, Ukraine, 61035
    - Research Site
  - Kharkiv, Ukraine, 61022
    - Research Site
  - Kyiv, Ukraine, 03680
    - Research Site
  - Kyiv, Ukraine, 04201
    - Research Site
  - Lutsk, Ukraine, 43000
    - Research Site
  - Uzhgorod, Ukraine, 88000
    - Research Site
  - Vinnytsia, Ukraine, 21029
    - Research Site
United Kingdom
- - Birmingham, United Kingdom, B9 5SS
    - Research Site
  - Bradford, United Kingdom, BD9 6RJ
    - Research Site
  - Cambridge, United Kingdom, CB2 0QQ
    - Research Site
  - Chertsey, United Kingdom, KT16 0PZ
    - Research Site
  - Chester, United Kingdom, CH2 1UL
    - Research Site
  - Cottingham, United Kingdom, HU16 5JQ
    - Research Site
  - Darlington, United Kingdom, DL3 6HX
    - Research Site
  - Glasgow, United Kingdom, G12 0YN
    - Research Site
  - Liverpool, United Kingdom, L7 8XP
    - Research Site
  - Manchester, United Kingdom, M23 9LT
    - Research Site
  - Nottingham, United Kingdom, NG5 1PB
    - Research Site
  - Plymouth, United Kingdom, PL6 8DH
    - Research Site
  - Portsmouth, United Kingdom, PO6 3LY
    - Research Site
  - Soham, United Kingdom, CB7 5JD
    - Research Site
  - Somerset, United Kingdom, BS26 2BJ
    - Research Site
  - Stevenage, United Kingdom, SG1 4AB
    - Research Site
  - Stockton, United Kingdom, TS19 8PE
    - Research Site
United States
- Alabama
  - Andalusia, Alabama, United States, 36420
    - Research Site
  - Birmingham, Alabama, United States, 35209
    - Research Site
  - Scottsboro, Alabama, United States, 35768
    - Research Site
- Arizona
  - Glendale, Arizona, United States, 85306
    - Research Site
  - Phoenix, Arizona, United States, 85012
    - Research Site
- California
  - Alhambra, California, United States, 91801
    - Research Site
  - Bakersfield, California, United States, 93301
    - Research Site
  - Newport Beach, California, United States, 92663
    - Research Site
  - Redondo Beach, California, United States, 90277
    - Research Site
  - Roseville, California, United States, 95661
    - Research Site
  - Sacramento, California, United States, 95825
    - Research Site
  - San Jose, California, United States, 95117
    - Research Site
  - Stockton, California, United States, 95204
    - Research Site
  - Walnut Creek, California, United States, 94598
    - Research Site
  - Westminster, California, United States, 92683
    - Research Site
  - Woodland, California, United States, 95695
    - Research Site
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - Research Site
  - Denver, Colorado, United States, 80206
    - Research Site
  - Wheat Ridge, Colorado, United States, 80033
    - Research Site
- Connecticut
  - New Haven, Connecticut, United States, 06520
    - Research Site
- Florida
  - Brandon, Florida, United States, 33511
    - Research Site
  - Clearwater, Florida, United States, 33765
    - Research Site
  - Cutler Bay, Florida, United States, 33189
    - Research Site
  - Doral, Florida, United States, 33172
    - Research Site
  - Hialeah, Florida, United States, 33012
    - Research Site
  - Hialeah, Florida, United States, 33013
    - Research Site
  - Homestead, Florida, United States, 33030
    - Research Site
  - Miami, Florida, United States, 33126
    - Research Site
  - Miami, Florida, United States, 33176
    - Research Site
  - Miami, Florida, United States, 33134
    - Research Site
  - Miami, Florida, United States, 33144
    - Research Site
  - Miami, Florida, United States, 33135
    - Research Site
  - Miami, Florida, United States, 33015
    - Research Site
  - Ocala, Florida, United States, 34471-4463
    - Research Site
  - Orlando, Florida, United States, 32825
    - Research Site
  - Orlando, Florida, United States, 32819
    - Research Site
  - Tampa, Florida, United States, 33607
    - Research Site
  - Winter Park, Florida, United States, 32789
    - Research Site
- Georgia
  - Albany, Georgia, United States, 31707
    - Research Site
  - Gainesville, Georgia, United States, 30501
    - Research Site
  - Lawrenceville, Georgia, United States, 30046
    - Research Site
- Illinois
  - Gurnee, Illinois, United States, 60031
    - Research Site
  - Normal, Illinois, United States, 61761
    - Research Site
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Research Site
- Kentucky
  - Fort Mitchell, Kentucky, United States, 41017
    - Research Site
  - Louisville, Kentucky, United States, 40215
    - Research Site
- Louisiana
  - Covington, Louisiana, United States, 70433
    - Research Site
- Maine
  - Bangor, Maine, United States, 04401
    - Research Site
- Maryland
  - Baltimore, Maryland, United States, 21236
    - Research Site
- Massachusetts
  - Quincy, Massachusetts, United States, 02169
    - Research Site
- Michigan
  - Farmington Hills, Michigan, United States, 48336
    - Research Site
  - Farmington Hills, Michigan, United States, 48334
    - Research Site
  - Flint, Michigan, United States, 48504
    - Research Site
  - Traverse City, Michigan, United States, 49684
    - Research Site
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Research Site
  - Saint Paul, Minnesota, United States, 55130
    - Research Site
- Missouri
  - Saint Louis, Missouri, United States, 63143
    - Research Site
- New Jersey
  - Northfield, New Jersey, United States, 08225
    - Research Site
  - Union, New Jersey, United States, 07083
    - Research Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - Research Site
- New York
  - Bronx, New York, United States, 10461
    - Research Site
  - New York, New York, United States, 10016
    - Research Site
  - Staten Island, New York, United States, 10305
    - Research Site
- North Carolina
  - Durham, North Carolina, United States, 27705
    - Research Site
  - Wilmington, North Carolina, United States, 28401
    - Research Site
  - Winston-Salem, North Carolina, United States, 27104
    - Research Site
- Ohio
  - Cincinnati, Ohio, United States, 45231
    - Research Site
  - Middleburg Heights, Ohio, United States, 44130
    - Research Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Research Site
  - Oklahoma City, Oklahoma, United States, 73120
    - Research Site
  - Oklahoma City, Oklahoma, United States, 73103
    - Research Site
  - Oklahoma City, Oklahoma, United States, 73131
    - Research Site
  - Tulsa, Oklahoma, United States, 74136
    - Research Site
- Pennsylvania
  - Jefferson Hills, Pennsylvania, United States, 15025
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19140
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15213
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15241
    - Research Site
- Rhode Island
  - Warwick, Rhode Island, United States, 02886
    - Research Site
- South Carolina
  - Hodges, South Carolina, United States, 29653
    - Research Site
- South Dakota
  - Rapid City, South Dakota, United States, 57702
    - Research Site
- Texas
  - Arlington, Texas, United States, 76018
    - Research Site
  - Boerne, Texas, United States, 78006
    - Research Site
  - Dallas, Texas, United States, 75225
    - Research Site
  - Dallas, Texas, United States, 75230
    - Research Site
  - Dallas, Texas, United States, 75235
    - Research Site
  - Houston, Texas, United States, 77058
    - Research Site
  - Houston, Texas, United States, 77099
    - Research Site
  - Houston, Texas, United States, 77081
    - Research Site
  - Houston, Texas, United States, 77083
    - Research Site
  - McAllen, Texas, United States, 78504
    - Research Site
  - McKinney, Texas, United States, 75069
    - Research Site
  - San Antonio, Texas, United States, 78229
    - Research Site
  - Splendora, Texas, United States, 77372
    - Research Site
- Utah
  - Provo, Utah, United States, 84604
    - Research Site
  - Salt Lake City, Utah, United States, 84112
    - Research Site
- Virginia
  - Abingdon, Virginia, United States, 24210
    - Research Site
  - Falls Church, Virginia, United States, 22044
    - Research Site
- Wisconsin
  - Greenfield, Wisconsin, United States, 53228
    - Research Site
  - Madison, Wisconsin, United States, 53792
    - Research Site
  - Milwaukee, Wisconsin, United States, 53226
    - Research Site
Vietnam
- - Hanoi, Vietnam, 100000
    - Research Site
  - Ho Chi Minh, Vietnam, 700000
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion criteria

Informed consent (and/or assent as applicable locally) for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent(s)/guardian(s)) and according to international guidelines and/or applicable European Union guidelines.
Female and male patients who completed the double-blind treatment period in a predecessor study on benralizumab or matching placebo.
Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after last dose of Investigational Product (IP).
For WOCBP only: Have a negative urine pregnancy test prior to administration of Investigational Product (IP) at Visit 1.
All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose.

Exclusion criteria

Any disorder including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric or major physical impairment that is not stable in the opinion of the Investigator and could:
- Affect the safety of the patient throughout the study
- Influence the findings of the studies or their interpretations
- Impede the patient's ability to complete the entire duration of study
A helminth parasitic infection diagnosed during a predecessor study that has either not been treated, has been incompletely treated or has failed to respond to standard of care therapy
Any clinically significant change in physical examination, vital signs, electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during a predecessor study which in the opinion of the investigator may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or interfere with the patient's ability to complete the entire duration of the study
Current malignancy or malignancy that developed during a predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded).
Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in this study, during the treatment period, and for 16 weeks (5 half-lives) after the last dose of the investigational product
Receipt of immunoglobulin or blood products within 30 days prior to Visit 1
Planned major surgical procedures during the conduct of the study
Previous participation in the present study
Concurrent enrolment in another clinical trial
AstraZeneca staff involved in the planning and/or conduct of the study
Employees of the study centre or any other individuals involved with the conduct of the study or immediate family members of such individuals
Patients with major protocol deviations in any of the predecessor studies at the discretion of the Sponsor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Other
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Benralizumab Arm A Benralizumab administered subcutaneously	Biological: Benralizumab Benralizumab administered subcutaneously
Experimental: Benralizumab Arm B Benralizumab administered subcutaneously	Biological: Benralizumab Benralizumab administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients Time Frame: Week 56	Change from baseline in hematologic lab parameter of Basophils.	Week 56
Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) Time Frame: Week 108	Change from baseline in hematologic lab parameter of Basophils.	Week 108
Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients Time Frame: Week 56	Change from baseline in hematologic lab parameter of Leukocytes.	Week 56
Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) Time Frame: Week 108	Change from baseline in hematologic lab parameter of Leukocytes.	Week 108
Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients Time Frame: Week 56	Change from baseline in hematologic lab parameter of Lymphocytes.	Week 56
Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) Time Frame: Week 108	Change from baseline in hematologic lab parameter of Lymphocytes.	Week 108
Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients Time Frame: Week 56	Change from baseline in hematologic lab parameter of Neutrophils.	Week 56
Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) Time Frame: Week 108	Change from baseline in hematologic lab parameter of Neutrophils.	Week 108
Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients Time Frame: Week 56	Change from baseline in hematologic lab parameter of Eosinophils.	Week 56
Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) Time Frame: Week 108	Change from baseline in hematologic lab parameter of Eosinophils.	Week 108
Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients Time Frame: Week 56	Change from baseline in chemistry tests ALT.	Week 56
Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) Time Frame: Week 108	Change from baseline in hematologic lab parameter of ALT.	Week 108
Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients Time Frame: Week 56	Change from baseline in chemistry tests AST.	Week 56
Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) Time Frame: Week 108	Change from baseline in hematologic lab parameter of AST.	Week 108
Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients Time Frame: Week 56	Change from baseline in chemistry test Bilirubin.	Week 56
Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) Time Frame: Week 108	Change from baseline in hematologic lab parameter of Bilirubin.	Week 108

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Overall Patients With Asthma Exacerbations During Study Period Time Frame: From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose)	Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit	From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose)
Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA) Time Frame: From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose)	Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit	From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose)
Change From Baseline in Pre-bronchodilator FEV1 (L) Time Frame: Week 56	Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).	Week 56
Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) Time Frame: Week 108	Change from baseline to Week 108 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).	Week 108
Change From Baseline in Post-bronchodilator FEV1 (L) Time Frame: Week 56	Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).	Week 56
Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA) Time Frame: Week 108	Change from baseline to Week 108 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).	Week 108
Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients Time Frame: Week 56	Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses.	Week 56
Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA) Time Frame: Week 108	Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses.	Week 108
Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12) Time Frame: Week 56	Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli). It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions. An increase in score indicates improvement.	Week 56
Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA) Time Frame: Week 108	Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli). It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions. An increase in score indicates improvement.	Week 108
Change of Blood Eosinophil Levels' Measurement in Overall Patients Time Frame: Week 56	Change from baseline to Week 56 in Blood eosinophils	Week 56
Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA). Time Frame: Week 108	Change from baseline to Week 108 in Blood eosinophils.	Week 108
Change From Baseline in EQ-5D-5L Visual Analog Scale Time Frame: Week 56	The questionnaire included a visual analog scale (VAS) score, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement.	Week 56
Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA) Time Frame: Week 108	The questionnaire included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement.	Week 108
Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI) Time Frame: Week 68	The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage.	Week 68
Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) Time Frame: Week 108	The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage.	Week 108
Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ) Time Frame: Week 56	The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage.	Week 56
Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA) Time Frame: Week 108	The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage.	Week 108
Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI) Time Frame: Week 68	The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.	Week 68
Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA) Time Frame: Week 108	The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.	Week 108
Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period Time Frame: From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose)	Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma	From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose)
Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA) Time Frame: Baseline and Week 108	Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma	Baseline and Week 108
Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study Time Frame: Week 0 and Week 56	Endpoint: Pharmacokinetic (PK) parameters	Week 0 and Week 56
Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA) Time Frame: Baseline and Week 108	Endpoint: Pharmacokinetic (PK) parameters	Baseline and Week 108
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study Time Frame: From week 0 to week 56 in study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period	Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study	From week 0 to week 56 in study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA) Time Frame: From week 0 to week 108 study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period	Assessments for the presence of ADA and nAb throughout study	From week 0 to week 108 study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Principal Investigator: William W. Busse, M.D., Professor of Medicine, Allergy, Pulmonary, and Critical Care Medicine 600 Highland Avenue; Madison, WI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2014

Primary Completion (Actual)

October 18, 2017

Study Completion (Actual)

July 2, 2018

Study Registration Dates

First Submitted

September 1, 2014

First Submitted That Met QC Criteria

October 3, 2014

First Posted (Estimate)

October 7, 2014

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases

Additional Relevant MeSH Terms

Other Study ID Numbers

D3250C00021
U1111-1162-2422 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Asthma

Clinical Trials on Benralizumab

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