Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)
19 de outubro de 2018 atualizado por: Sanofi
A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma
Primary Objective:
To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent asthma.
Secondary Objectives:
- To evaluate the safety and tolerability of dupilumab.
- To evaluate the effect of dupilumab on improving participant-reported outcomes including health-related quality of life.
- To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
The total duration of study period for each participant is 67 to 69 weeks, including a screening period of 3 to 5 weeks, treatment period of 52 weeks, and post-treatment follow-up period of 12 weeks.
Tipo de estudo
Intervencional
Inscrição (Real)
1902
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Berlin, Alemanha, 10787
- Investigational Site Number 276006
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Bochum, Alemanha, 44789
- Investigational Site Number 276003
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Frankfurt Am Main, Alemanha, 60596
- Investigational Site Number 276010
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Hannover, Alemanha, 30625
- Investigational Site Number 276004
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Koblenz, Alemanha, 56068
- Investigational Site Number 276009
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Lübeck, Alemanha, 23538
- Investigational Site Number 276007
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Mainz, Alemanha, 55131
- Investigational Site Number 276001
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Rüdersdorf, Alemanha, 15562
- Investigational Site Number 276005
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Bahia Blanca, Argentina, B8000JRB
- Investigational Site Number 032006
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Buenos Aires, Argentina, C1121ABE
- Investigational Site Number 032002
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Caba, Argentina, 1120
- Investigational Site Number 032011
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Caba, Argentina, C1425BEN
- Investigational Site Number 032001
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Caba, Argentina, C1414AIF
- Investigational Site Number 032007
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Caba, Argentina, C1425FVH
- Investigational Site Number 032003
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Caba, Argentina, C1426ABP
- Investigational Site Number 032010
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Capital Federal, Argentina, C1425DUC
- Investigational Site Number 032005
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La Plata, Argentina, B1900DXM
- Investigational Site Number 032008
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Rosario, Argentina, S2000JKR
- Investigational Site Number 032004
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San Miguel De Tucuman, Argentina, T4000CHE
- Investigational Site Number 032012
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San Miguel De Tucumán, Argentina, T4000IAR
- Investigational Site Number 032009
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Campbelltown, Austrália, 2560
- Investigational Site Number 036005
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Clayton, Austrália, 3168
- Investigational Site Number 036001
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Frankston, Austrália, 3199
- Investigational Site Number 036002
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Glen Osmond, Austrália, 5064
- Investigational Site Number 036006
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Murdoch, Austrália, 6150
- Investigational Site Number 036003
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Parkville, Austrália, 3050
- Investigational Site Number 036004
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Florianópolis, Brasil, 88040-970
- Investigational Site Number 076009
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Porto Alegre, Brasil, 90610-000
- Investigational Site Number 076001
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Porto Alegre, Brasil, 90020-090
- Investigational Site Number 076007
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Salvador, Brasil, 41940-455
- Investigational Site Number 076003
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Sao Paulo, Brasil, 04266-010
- Investigational Site Number 076012
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Sao Paulo, Brasil, 05403-000
- Investigational Site Number 076008
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Sao Paulo, Brasil, 05437-010
- Investigational Site Number 076006
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Sorocaba, Brasil, 18040-425
- Investigational Site Number 076002
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São Bernardo Do Campo, Brasil, 09715-090
- Investigational Site Number 076013
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Burlington, Canadá, L7N 3V2
- Investigational Site Number 124019
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Calgary, Canadá, T2N 4Z6
- Investigational Site Number 124009
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Mississauga, Canadá, L5A 3V4
- Investigational Site Number 124003
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Montreal, Canadá, H2W 1T8
- Investigational Site Number 124001
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Montreal, Canadá, H4A 3J1
- Investigational Site Number 124012
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Montreal, Canadá, H4J 1C5
- Investigational Site Number 124010
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Ottawa, Canadá, K1G 6C6
- Investigational Site Number 124013
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Quebec, Canadá, G1V 4G5
- Investigational Site Number 124018
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Quebec, Canadá, G1V 4W2
- Investigational Site Number 124014
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Sherbrooke, Canadá, J1H 5N4
- Investigational Site Number 124008
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Toronto, Canadá, M5G 1E2
- Investigational Site Number 124015
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Toronto, Canadá, M5T 3A9
- Investigational Site Number 124002
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Trois-Rivieres, Canadá, G8T 7A1
- Investigational Site Number 124007
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Vancouver, Canadá, V5Z 1M9
- Investigational Site Number 124006
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Concepción, Chile, 41
- Investigational Site Number 152015
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Quillota, Chile, 2260877
- Investigational Site Number 152003
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Santiago, Chile, 7500588
- Investigational Site Number 152014
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Santiago, Chile, 7500692
- Investigational Site Number 152001
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Santiago, Chile, 7500698
- Investigational Site Number 152002
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Santiago, Chile, 7500710
- Investigational Site Number 152008
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Santiago, Chile, 7560994
- Investigational Site Number 152017
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Santiago, Chile, 8207257
- Investigational Site Number 152007
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Santiago, Chile, 8380456
- Investigational Site Number 152005
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Santiago, Chile, 8910131
- Investigational Site Number 152009
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Talca, Chile, 3460001
- Investigational Site Number 152004
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Talcahuano, Chile, 427918
- Investigational Site Number 152013
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Temuco, Chile, 4781156
- Investigational Site Number 152016
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Valdivia, Chile
- Investigational Site Number 152010
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Viña Del Mar, Chile, 2520594
- Investigational Site Number 152011
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Viña Del Mar, Chile
- Investigational Site Number 152012
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Bogota, Colômbia, 110221
- Investigational Site Number 170001
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Bogota, Colômbia, 110131
- Investigational Site Number 170006
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Bogotá, Colômbia, 110231
- Investigational Site Number 170002
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Bogotá, Colômbia, 111321
- Investigational Site Number 170003
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Barcelona, Espanha, 08036
- Investigational Site Number 724001
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Barcelona, Espanha, 08035
- Investigational Site Number 724002
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Palma De Mallorca, Espanha, 07120
- Investigational Site Number 724010
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Pozuelo De Alarcón, Espanha, 28223
- Investigational Site Number 724005
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Sant Boi De Llobregat, Espanha, 08830
- Investigational Site Number 724004
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Santiago De Compostela, Espanha, 15706
- Investigational Site Number 724006
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Sevilla, Espanha, 41071
- Investigational Site Number 724008
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Valencia, Espanha, 46017
- Investigational Site Number 724007
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Alabama
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Birmingham, Alabama, Estados Unidos, 35209
- Investigational Site Number 840047
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Arizona
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Flagstaff, Arizona, Estados Unidos, 86001
- Investigational Site Number 840056
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Gilbert, Arizona, Estados Unidos, 85234
- Investigational Site Number 840099
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Scottsdale, Arizona, Estados Unidos, 85251
- Investigational Site Number 840087
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72209
- Investigational Site Number 840132
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California
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Bakersfield, California, Estados Unidos, 93301
- Investigational Site Number 840109
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Costa Mesa, California, Estados Unidos, 92626
- Investigational Site Number 840052
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Fresno, California, Estados Unidos, 93720
- Investigational Site Number 840116
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Long Beach, California, Estados Unidos, 90720
- Investigational Site Number 840045
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Los Angeles, California, Estados Unidos, 90025
- Investigational Site Number 840011
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Los Angeles, California, Estados Unidos, 90048
- Investigational Site Number 840061
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Los Angeles, California, Estados Unidos, 90064
- Investigational Site Number 840097
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Mission Viejo, California, Estados Unidos, 92691
- Investigational Site Number 840019
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Newport Beach, California, Estados Unidos, 92663
- Investigational Site Number 840125
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North Hollywood, California, Estados Unidos, 91606
- Investigational Site Number 840041
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Redwood City, California, Estados Unidos, 94063
- Investigational Site Number 840036
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Rolling Hills Estates, California, Estados Unidos, 90274
- Investigational Site Number 840020
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Roseville, California, Estados Unidos, 95661
- Investigational Site Number 840074
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San Jose, California, Estados Unidos, 95117
- Investigational Site Number 840021
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Colorado
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Centennial, Colorado, Estados Unidos, 80112
- Investigational Site Number 840004
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Colorado Springs, Colorado, Estados Unidos, 80907
- Investigational Site Number 840025
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Denver, Colorado, Estados Unidos, 80246
- Investigational Site Number 840130
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Denver, Colorado, Estados Unidos, 80230
- Investigational Site Number 840034
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06504
- Investigational Site Number 840102
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Florida
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Aventura, Florida, Estados Unidos, 33180
- Investigational Site Number 840037
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Boynton Beach, Florida, Estados Unidos, 33472
- Investigational Site Number 840018
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Brandon, Florida, Estados Unidos, 33511
- Investigational Site Number 840105
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Clearwater, Florida, Estados Unidos, 33765
- Investigational Site Number 840092
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Hialeah, Florida, Estados Unidos, 33012
- Investigational Site Number 840122
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Loxahatchee Groves, Florida, Estados Unidos, 33470
- Investigational Site Number 840053
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Miami, Florida, Estados Unidos, 33173
- Investigational Site Number 840069
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Ocala, Florida, Estados Unidos, 34471
- Investigational Site Number 840123
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Ocala, Florida, Estados Unidos, 34474
- Investigational Site Number 840071
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Ocoee, Florida, Estados Unidos, 34761
- Investigational Site Number 840115
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Sarasota, Florida, Estados Unidos, 34239
- Investigational Site Number 840055
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South Miami, Florida, Estados Unidos, 33143
- Investigational Site Number 840114
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Tampa, Florida, Estados Unidos, 33612
- Investigational Site Number 840048
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Georgia
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Gainesville, Georgia, Estados Unidos, 30506
- Investigational Site Number 840084
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Savannah, Georgia, Estados Unidos, 31406
- Investigational Site Number 840044
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Idaho
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Twin Falls, Idaho, Estados Unidos, 83301
- Investigational Site Number 840079
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Investigational Site Number 840101
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River Forest, Illinois, Estados Unidos, 60305
- Investigational Site Number 840015
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- Investigational Site Number 840089
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Kentucky
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Fort Mitchell, Kentucky, Estados Unidos, 41017
- Investigational Site Number 840032
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Owensboro, Kentucky, Estados Unidos, 42303
- Investigational Site Number 840009
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Maine
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Bangor, Maine, Estados Unidos, 04401
- Investigational Site Number 840064
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Maryland
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Baltimore, Maryland, Estados Unidos, 21237
- Investigational Site Number 840080
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Chevy Chase, Maryland, Estados Unidos, 20815
- Investigational Site Number 840017
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Gaithersburg, Maryland, Estados Unidos, 20878
- Investigational Site Number 840073
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White Marsh, Maryland, Estados Unidos, 21162
- Investigational Site Number 840127
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Massachusetts
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North Dartmouth, Massachusetts, Estados Unidos, 02747
- Investigational Site Number 840014
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55402
- Investigational Site Number 840005
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Missouri
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Kansas City, Missouri, Estados Unidos, 64111
- Investigational Site Number 840013
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Saint Louis, Missouri, Estados Unidos, 63141
- Investigational Site Number 840002
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Saint Louis, Missouri, Estados Unidos, 63141
- Investigational Site Number 840093
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Montana
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Missoula, Montana, Estados Unidos, 59808
- Investigational Site Number 840026
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68131
- Investigational Site Number 840078
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Papillion, Nebraska, Estados Unidos, 27103
- Investigational Site Number 840003
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New Jersey
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Brick, New Jersey, Estados Unidos, 08723
- Investigational Site Number 840111
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Ocean City, New Jersey, Estados Unidos, 07712
- Investigational Site Number 840068
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Princeton, New Jersey, Estados Unidos, 08540
- Investigational Site Number 840016
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Toms River, New Jersey, Estados Unidos, 08775
- Investigational Site Number 840096
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New York
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Bronx, New York, Estados Unidos, 10457
- Investigational Site Number 840031
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Jamaica, New York, Estados Unidos, 11435
- Investigational Site Number 840106
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New York, New York, Estados Unidos, 10029
- Investigational Site Number 840065
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Rochester, New York, Estados Unidos, 14642
- Investigational Site Number 840076
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28226
- Investigational Site Number 840126
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Charlotte, North Carolina, Estados Unidos, 28277
- Investigational Site Number 840083
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Durham, North Carolina, Estados Unidos, 27705
- Investigational Site Number 840108
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Greensboro, North Carolina, Estados Unidos, 27403
- Investigational Site Number 840107
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High Point, North Carolina, Estados Unidos, 27262
- Investigational Site Number 840007
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45241
- Investigational Site Number 840046
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Middleburg Heights, Ohio, Estados Unidos, 44130
- Investigational Site Number 840049
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Toledo, Ohio, Estados Unidos, 43617
- Investigational Site Number 840042
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Oklahoma
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Edmond, Oklahoma, Estados Unidos, 73034
- Investigational Site Number 840112
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Oklahoma City, Oklahoma, Estados Unidos, 73103
- Investigational Site Number 840121
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Tulsa, Oklahoma, Estados Unidos, 74136
- Investigational Site Number 840104
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Oregon
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Clackamas, Oregon, Estados Unidos, 97015
- Investigational Site Number 840040
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Medford, Oregon, Estados Unidos, 97504
- Investigational Site Number 840039
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Portland, Oregon, Estados Unidos, 97223
- Investigational Site Number 840001
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033
- Investigational Site Number 840085
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Philadelphia, Pennsylvania, Estados Unidos, 19140
- Investigational Site Number 840067
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Philadelphia, Pennsylvania, Estados Unidos, 19102
- Investigational Site Number 840081
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Investigational Site Number 840010
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Investigational Site Number 840028
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Pittsburgh, Pennsylvania, Estados Unidos, 15241
- Investigational Site Number 840091
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Rhode Island
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Lincoln, Rhode Island, Estados Unidos, 02286
- Investigational Site Number 840029
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29407
- Investigational Site Number 840082
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Greenville, South Carolina, Estados Unidos, 29607
- Investigational Site Number 840117
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Greer, South Carolina, Estados Unidos, 29651
- Investigational Site Number 840100
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Spartanburg, South Carolina, Estados Unidos, 29303
- Investigational Site Number 840054
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Texas
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Amarillo, Texas, Estados Unidos, 79106
- Investigational Site Number 840062
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Austin, Texas, Estados Unidos, 78759
- Investigational Site Number 840098
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Boerne, Texas, Estados Unidos, 78006
- Investigational Site Number 840038
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Cypress, Texas, Estados Unidos, 77429
- Investigational Site Number 840124
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Dallas, Texas, Estados Unidos, 75231
- Investigational Site Number 840008
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Dallas, Texas, Estados Unidos, 75246
- Investigational Site Number 840094
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El Paso, Texas, Estados Unidos, 79903
- Investigational Site Number 840023
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Fort Worth, Texas, Estados Unidos, 76244
- Investigational Site Number 840027
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Fort Worth, Texas, Estados Unidos, 76109
- Investigational Site Number 840022
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Killeen, Texas, Estados Unidos, 76542
- Investigational Site Number 840066
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Live Oak, Texas, Estados Unidos, 78233
- Investigational Site Number 840050
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McKinney, Texas, Estados Unidos, 75069
- Investigational Site Number 840070
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McKinney, Texas, Estados Unidos, 75071
- Investigational Site Number 840128
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Plano, Texas, Estados Unidos, 75093
- Investigational Site Number 840118
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San Antonio, Texas, Estados Unidos, 78229
- Investigational Site Number 840012
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San Antonio, Texas, Estados Unidos, 78251
- Investigational Site Number 840129
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Sealy, Texas, Estados Unidos, 77474
- Investigational Site Number 840133
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Spring, Texas, Estados Unidos, 77380
- Investigational Site Number 840119
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Utah
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Draper, Utah, Estados Unidos, 84020
- Investigational Site Number 840035
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Murray, Utah, Estados Unidos, 84107
- Investigational Site Number 840077
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Vermont
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South Burlington, Vermont, Estados Unidos, 05403
- Investigational Site Number 840057
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Virginia
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Fairfax, Virginia, Estados Unidos, 22030
- Investigational Site Number 840059
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Richmond, Virginia, Estados Unidos, 23294
- Investigational Site Number 840113
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Washington
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Bellevue, Washington, Estados Unidos, 98225
- Investigational Site Number 840051
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Spokane, Washington, Estados Unidos, 99202
- Investigational Site Number 840043
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Ekaterinburg, Federação Russa, 620109
- Investigational Site Number 643013
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Moscow, Federação Russa, 115280
- Investigational Site Number 643005
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Moscow, Federação Russa, 125315
- Investigational Site Number 643001
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Moscow, Federação Russa, 105077
- Investigational Site Number 643006
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Moscow, Federação Russa, 109240
- Investigational Site Number 643003
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Moscow, Federação Russa, 117574
- Investigational Site Number 643002
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Moscow, Federação Russa, 123182
- Investigational Site Number 643004
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Ryazan, Federação Russa, 390039
- Investigational Site Number 643011
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Saint-Petersburg, Federação Russa, 194354
- Investigational Site Number 643008
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Saint-Petersburg, Federação Russa, 195030
- Investigational Site Number 643009
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St-Petersburg, Federação Russa, 193231
- Investigational Site Number 643007
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St-Petersburg, Federação Russa, 197022
- Investigational Site Number 643010
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Yaroslavl, Federação Russa, 150003
- Investigational Site Number 643012
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Brest, França, 29609
- Investigational Site Number 250002
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Lille, França, 59000
- Investigational Site Number 250013
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Lille Cedex, França, 59037
- Investigational Site Number 250011
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Lyon, França, 69317
- Investigational Site Number 250004
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Marseille, França, 13015
- Investigational Site Number 250010
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Montpellier, França, 34295
- Investigational Site Number 250005
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Nantes Cedex 1, França, 44093
- Investigational Site Number 250003
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Paris, França, 75012
- Investigational Site Number 250012
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Paris, França, 75018
- Investigational Site Number 250001
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Strasbourg, França, 67091
- Investigational Site Number 250008
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Vandoeuvre-Les-Nancy, França, 54511
- Investigational Site Number 250014
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Gödöllö, Hungria, 2100
- Investigational Site Number 348003
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Ancona, Itália, 60126
- Investigational Site Number 380004
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Catania, Itália, 95123
- Investigational Site Number 380005
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Ferrara, Itália, 44124
- Investigational Site Number 380003
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Firenze, Itália, 50134
- Investigational Site Number 380006
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Foggia, Itália, 71122
- Investigational Site Number 380010
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Modena, Itália, 41124
- Investigational Site Number 380002
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Palermo, Itália, 90146
- Investigational Site Number 380009
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Pisa, Itália, 56124
- Investigational Site Number 380001
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Reggio Emilia, Itália, 42123
- Investigational Site Number 380014
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Torino, Itália, 10128
- Investigational Site Number 380011
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Akashi-Shi, Japão
- Investigational Site Number 392185
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Asahikawa-Shi, Japão
- Investigational Site Number 392128
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Chiyoda-Ku, Japão
- Investigational Site Number 392118
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Chuo-Ku, Japão
- Investigational Site Number 392112
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Fukui-Shi, Japão
- Investigational Site Number 392157
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Fukuoka-Shi, Japão
- Investigational Site Number 392137
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Fukuyama-Shi, Japão
- Investigational Site Number 392117
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Habikino-Shi, Japão
- Investigational Site Number 392121
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Higashiosaka-Shi, Japão
- Investigational Site Number 392154
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Himeji-Shi, Japão
- Investigational Site Number 392109
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Hiroshima-Shi, Japão
- Investigational Site Number 392108
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Hiroshima-Shi, Japão
- Investigational Site Number 392158
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Iizuka-Shi, Japão
- Investigational Site Number 392107
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Isesaki-Shi, Japão
- Investigational Site Number 392101
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Itabashi-Ku, Japão
- Investigational Site Number 392147
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Kagoshima-Shi, Japão
- Investigational Site Number 392150
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Kagoshima-Shi, Japão
- Investigational Site Number 392178
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Kanazawa-Shi, Japão
- Investigational Site Number 392110
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Kanazawa-Shi, Japão
- Investigational Site Number 392136
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Kasuga-Shi, Japão
- Investigational Site Number 392142
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Kawaguchi-Shi, Japão
- Investigational Site Number 392166
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Kishiwada-Shi, Japão
- Investigational Site Number 392119
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Kobe-Shi, Japão
- Investigational Site Number 392162
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Kodaira-Shi, Japão
- Investigational Site Number 392182
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Kokubunji-Shi, Japão
- Investigational Site Number 392174
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Koshi-Shi, Japão
- Investigational Site Number 392131
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Koshigaya-Shi, Japão
- Investigational Site Number 392183
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Kurashiki-Shi, Japão
- Investigational Site Number 392129
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Kyoto-Shi, Japão
- Investigational Site Number 392153
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Kyoto-Shi, Japão
- Investigational Site Number 392176
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Kyoto-Shi, Japão
- Investigational Site Number 392184
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Machida-Shi, Japão
- Investigational Site Number 392133
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Matsuyama-Shi, Japão
- Investigational Site Number 392135
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Mibu, Japão
- Investigational Site Number 392172
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Minato-Ku, Japão
- Investigational Site Number 392122
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Minato-Ku, Japão
- Investigational Site Number 392144
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Minato-Ku, Japão
- Investigational Site Number 392114
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Mizunami-Shi, Japão
- Investigational Site Number 392106
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Muroran-Shi, Japão
- Investigational Site Number 392164
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Nagakute-Shi, Japão
- Investigational Site Number 392161
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Nagoya-Shi, Japão
- Investigational Site Number 392163
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Naka-Gun, Japão
- Investigational Site Number 392102
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Nakano-Ku, Japão
- Investigational Site Number 392125
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Naruto-Shi, Japão
- Investigational Site Number 392115
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Obihiro-Shi, Japão
- Investigational Site Number 392187
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Ome-Shi, Japão
- Investigational Site Number 392177
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Osaka Sayama-Shi, Japão
- Investigational Site Number 392152
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Osaka Sayama-Shi, Japão
- Investigational Site Number 392155
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Osaki-Shi, Japão
- Investigational Site Number 392170
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Ota-Ku, Japão
- Investigational Site Number 392127
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Ota-Ku, Japão
- Investigational Site Number 392120
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Ota-Shi, Japão
- Investigational Site Number 392138
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Oura-Gun, Japão
- Investigational Site Number 392123
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Sagamihara-Shi, Japão
- Investigational Site Number 392169
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Sapporo-Shi, Japão
- Investigational Site Number 392149
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Seto-Shi, Japão
- Investigational Site Number 392179
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Shibuya-Ku, Japão
- Investigational Site Number 392186
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Shinagawa-Ku, Japão
- Investigational Site Number 392167
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Shinagawa-Ku, Japão
- Investigational Site Number 392139
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Shinjuku-Ku, Japão
- Investigational Site Number 392130
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Sumida-Ku, Japão
- Investigational Site Number 392165
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Tachikawa-Shi, Japão
- Investigational Site Number 392146
-
Tachikawa-Shi, Japão
- Investigational Site Number 392173
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Tokyo, Japão
- Investigational Site Number 392103
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Tomakomai-Shi, Japão
- Investigational Site Number 392113
-
Tsu-Shi, Japão
- Investigational Site Number 392151
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Uozu-Shi, Japão
- Investigational Site Number 392168
-
Urasoe-Shi, Japão
- Investigational Site Number 392132
-
Uruma-Shi, Japão
- Investigational Site Number 392134
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Wakayama-Shi, Japão
- Investigational Site Number 392116
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Yokohama-Shi, Japão
- Investigational Site Number 392140
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Yonago-Shi, Japão
- Investigational Site Number 392159
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-
-
-
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Chihuahua, México, 31020
- Investigational Site Number 484013
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Chihuahua, México, 31200
- Investigational Site Number 484006
-
Cuautitlan Izcalli, México, 54769
- Investigational Site Number 484014
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Durango, México, 34080
- Investigational Site Number 484008
-
Guadalajara, México, 44100
- Investigational Site Number 484001
-
Mexico City, México, 64718
- Investigational Site Number 484004
-
Monterrey, México, 64460
- Investigational Site Number 484003
-
Monterrey, México, 66465
- Investigational Site Number 484007
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México, México, 06700
- Investigational Site Number 484010
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San Juan Del Rio, México, 76800
- Investigational Site Number 484012
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Veracruz, México, 91910
- Investigational Site Number 484011
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Zapopan, México, 45100
- Investigational Site Number 484015
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-
-
-
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Ankara, Peru, 06100
- Investigational Site Number 792004
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Ankara, Peru, 06100
- Investigational Site Number 792008
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Bursa, Peru, 16059
- Investigational Site Number 792003
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Istanbul, Peru, 34098
- Investigational Site Number 792001
-
Istanbul, Peru, 34668
- Investigational Site Number 792007
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Izmir, Peru, 35040
- Investigational Site Number 792005
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Izmir, Peru, 35110
- Investigational Site Number 792010
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Kirikkale, Peru, 71450
- Investigational Site Number 792009
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Kocaeli, Peru, 41100
- Investigational Site Number 792011
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Mersin, Peru, 33070
- Investigational Site Number 792002
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Rize, Peru, 53100
- Investigational Site Number 792006
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-
-
-
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Bialystok, Polônia, 15-010
- Investigational Site Number 616006
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Gdansk, Polônia, 80-952
- Investigational Site Number 616003
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Krakow, Polônia, 31-159
- Investigational Site Number 616007
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Lodz, Polônia, 90-141
- Investigational Site Number 616001
-
Lodz, Polônia, 90-153
- Investigational Site Number 616005
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Lodz, Polônia, 90-329
- Investigational Site Number 616009
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Poznan, Polônia, 60-693
- Investigational Site Number 616002
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Sopot, Polônia, 81-741
- Investigational Site Number 616004
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Strzelce Opolskie, Polônia, 47-100
- Investigational Site Number 616008
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-
-
-
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Bradford, Reino Unido, BD9 6RJ
- Investigational Site Number 826001
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London, Reino Unido, EC1M 6BQ
- Investigational Site Number 826002
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Newcastle Upon Tyne, Reino Unido, NE7 7DN
- Investigational Site Number 826005
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Portsmouth, Reino Unido, PO6 3LY
- Investigational Site Number 826007
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South Shields, Reino Unido, NE34 0PL
- Investigational Site Number 826006
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Sutton-In-Ashfield, Reino Unido, NG17 4JL
- Investigational Site Number 826003
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-
-
-
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Bucheon-Si, Republica da Coréia, 14584
- Investigational Site Number 410002
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Busan, Republica da Coréia, 49201
- Investigational Site Number 410015
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Cheongju-Si, Republica da Coréia, 28644
- Investigational Site Number 410003
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Incheon, Republica da Coréia, 21565
- Investigational Site Number 410013
-
Seoul, Republica da Coréia, 04763
- Investigational Site Number 410012
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Seoul, Republica da Coréia, 03080
- Investigational Site Number 410006
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Seoul, Republica da Coréia, 03722
- Investigational Site Number 410004
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Seoul, Republica da Coréia, 05505
- Investigational Site Number 410005
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Seoul, Republica da Coréia, 06351
- Investigational Site Number 410007
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Seoul, Republica da Coréia, 06973
- Investigational Site Number 410010
-
Seoul, Republica da Coréia, 08308
- Investigational Site Number 410011
-
Seoul, Republica da Coréia, 02559
- Investigational Site Number 410008
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Seoul, Republica da Coréia, 06591
- Investigational Site Number 410009
-
Suwon, Republica da Coréia, 16499
- Investigational Site Number 410001
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Uijeongbu-Si, Republica da Coréia, 11765
- Investigational Site Number 410014
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-
-
-
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Kaohsiung, Taiwan, 807
- Investigational Site Number 158004
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Kaohsiung, Taiwan, 82445
- Investigational Site Number 158002
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New Taipei City, Taiwan, 23561
- Investigational Site Number 158008
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Taichung, Taiwan, 40447
- Investigational Site Number 158007
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Taichung, Taiwan, 40201
- Investigational Site Number 158005
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Taipei, Taiwan, 10043
- Investigational Site Number 158001
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Taipei, Taiwan, 11031
- Investigational Site Number 158009
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Taoyuan, Taiwan, 333
- Investigational Site Number 158006
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-
-
-
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Chernivtsi, Ucrânia, 58001
- Investigational Site Number 804007
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Dnipro, Ucrânia, 49101
- Investigational Site Number 804023
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Ivano-Frankivsk, Ucrânia, 76018
- Investigational Site Number 804009
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Ivano-Frankivsk, Ucrânia, 76018
- Investigational Site Number 804004
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Kharkiv, Ucrânia, 61058
- Investigational Site Number 804005
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Kharkiv, Ucrânia, 61093
- Investigational Site Number 804021
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Kharkiv, Ucrânia, 61124
- Investigational Site Number 804001
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Kyiv, Ucrânia, 03680
- Investigational Site Number 804003
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Kyiv, Ucrânia, 03680
- Investigational Site Number 804008
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Kyiv, Ucrânia, 03680
- Investigational Site Number 804017
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Kyiv, Ucrânia, 04050
- Investigational Site Number 804016
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Kyiv, Ucrânia, 03680
- Investigational Site Number 804011
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Kyiv, Ucrânia, 03680
- Investigational Site Number 804013
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Odessa, Ucrânia, 65025
- Investigational Site Number 804006
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Poltava, Ucrânia, 36038
- Investigational Site Number 804002
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Ternopil, Ucrânia, 46000
- Investigational Site Number 804014
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Vinnytsya, Ucrânia, 21001
- Investigational Site Number 804012
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Zaporizhia, Ucrânia, 69076
- Investigational Site Number 804022
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-
-
-
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Brandfort, África do Sul, 9400
- Investigational Site Number 710009
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Cape Town, África do Sul, 7505
- Investigational Site Number 710011
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Cape Town, África do Sul, 8000
- Investigational Site Number 710003
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Cape Town, África do Sul, 7700
- Investigational Site Number 710001
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Cape Town, África do Sul, 7764
- Investigational Site Number 710010
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Cape Town, África do Sul, 7530
- Investigational Site Number 710004
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Cape Town, África do Sul, 7700
- Investigational Site Number 710002
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Durban, África do Sul, 4071
- Investigational Site Number 710006
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Durban, África do Sul, 4001
- Investigational Site Number 710005
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Pretoria, África do Sul, 0087
- Investigational Site Number 710007
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
12 anos e mais velhos (Filho, Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion criteria:
-Adults and adolescent participants with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2014 Guidelines and the following criteria:
a) Existing treatment with medium to high dose ICS (≥250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta agonist, leukotriene receptor antagonist) for at least 3 months with a stable dose ≥1 month prior to Visit 1.
i) Note for Japan: for participants aged 18 years and older, ICS must be on ≥200 mcg of fluticasone propionate twice daily or equivalent; for participants aged 12 to 17 years, ICS must be ≥100 mcg of fluticasone propionate twice daily or equivalent).
ii) Participants requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose ≥1 month prior to Visit 1.
Exclusion criteria:
- Participants <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (For those countries where local regulations permit enrollment of adults only, participant recruitment will be restricted to those who are ≥18 years of age).
- Weight is less than 30 kilograms.
- Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function.
- A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to the Screening Visit up to and including the Baseline Visit).
- Evidence of lung disease(s) other than asthma, either clinical evidence or imaging (Chest X-ray, CT, MRI) within 12 months of Visit 1 or at the screening visit, as per local standard of care.
- Note for Japan: According to the request from the health authority, chest X-ray should be performed at screening visit if there is no chest imaging (Chest X-ray, computed tomography [CT], magnetic resonance imaging [MRI]) available within 3 months prior to screening to exclude participants with suspected active or untreated latent tuberculosis.
- Current smoker or cessation of smoking within 6 months prior to Visit 1.
- Previous smoker with a smoking history >10 pack-years.
- Comorbid disease that might interfere with the evaluation of Investigational Medicinal Product.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Placebo (for Dupilumab 200 mg) q2w
2 subcutaneous injections of matched Placebo (for Dupilumab 200 mg) as a loading dose on Day 1 (Week 0), followed by a single injection every 2 weeks (q2w) from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines.
Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
|
Solução injectável, Injecção subcutânea no abdómen, parte superior da coxa ou parte superior do braço.
Oral inhalation, stable dose (medium or high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy)
Oral inhalation as needed
Oral inhalation as needed
|
|
Experimental: Dupilumab 200 mg q2w
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 0), followed by a single 200 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines.
Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
|
Solução injectável, Injecção subcutânea no abdómen, parte superior da coxa ou parte superior do braço.
Outros nomes:
Oral inhalation, stable dose (medium or high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy)
Oral inhalation as needed
Oral inhalation as needed
|
|
Comparador de Placebo: Placebo (for Dupilumab 300 mg) q2w
2 subcutaneous injections of matched Placebo (for Dupilumab 300 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines.
Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
|
Solução injectável, Injecção subcutânea no abdómen, parte superior da coxa ou parte superior do braço.
Oral inhalation, stable dose (medium or high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy)
Oral inhalation as needed
Oral inhalation as needed
|
|
Experimental: Dupilumab 300 mg q2w
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 0), followed by a single 300 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines .
Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
|
Solução injectável, Injecção subcutânea no abdómen, parte superior da coxa ou parte superior do braço.
Outros nomes:
Oral inhalation, stable dose (medium or high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy)
Oral inhalation as needed
Oral inhalation as needed
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population
Prazo: Baseline to Week 52
|
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
|
Baseline to Week 52
|
|
Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population
Prazo: Baseline, Week 12
|
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
|
Baseline, Week 12
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population
Prazo: Baseline, Week 12
|
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
|
Baseline, Week 12
|
|
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.15 Giga/L
Prazo: Baseline to Week 52
|
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
|
Baseline to Week 52
|
|
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L
Prazo: Baseline, Week 12
|
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
|
Baseline, Week 12
|
|
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.3 Giga/L
Prazo: Baseline to Week 52
|
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
|
Baseline to Week 52
|
|
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L
Prazo: Baseline, Week 12
|
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
|
Baseline, Week 12
|
|
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil <0.3 Giga/L
Prazo: Baseline to Week 52
|
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
|
Baseline to Week 52
|
|
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With High Dose ICS at Baseline
Prazo: Baseline to Week 52
|
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
|
Baseline to Week 52
|
|
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline
Prazo: Baseline, Week 12
|
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
|
Baseline, Week 12
|
|
Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population
Prazo: Baseline, Week 24
|
The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma.
The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items).
Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment).
The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all).
Higher scores indicate better quality of life.
|
Baseline, Week 24
|
|
Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L
Prazo: Baseline, Week 24
|
The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma.
The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items).
Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment).
The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all).
Higher scores indicate better quality of life.
|
Baseline, Week 24
|
|
Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population
Prazo: Baseline, Week 24
|
The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze.
Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment).
ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled).
Higher score indicated lower asthma control.
|
Baseline, Week 24
|
|
Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During The 52-Week Treatment Period: ITT Population
Prazo: Baseline to Week 52
|
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
Annualized event rate was the total number of exacerbations (resulted hospitalization or emergency room visit) that occurred during the treatment period divided by the total number of participant-years treated.
|
Baseline to Week 52
|
|
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil <0.3 Giga/L
Prazo: Baseline, Week 12
|
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
|
Baseline, Week 12
|
|
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L
Prazo: Baseline, Week 12
|
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
|
Baseline, Week 12
|
|
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline
Prazo: Baseline, Week 12
|
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
|
Baseline, Week 12
|
|
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L
Prazo: Baseline, Week 12
|
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
|
Baseline, Week 12
|
|
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population
Prazo: Baseline, Weeks 2, 4, 8, 24, 36, and 52
|
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
|
Baseline, Weeks 2, 4, 8, 24, 36, and 52
|
|
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population
Prazo: Baseline, Weeks 2, 4, 8, 24, 36, and 52
|
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
|
Baseline, Weeks 2, 4, 8, 24, 36, and 52
|
|
Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Prazo: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
|
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
|
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
|
|
Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Prazo: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
|
The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter.
Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma.
|
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Prazo: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
|
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness.
FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters.
|
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
|
|
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Prazo: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
|
FEF is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
FEF25-75% is defined as the mean forced expiratory flow between the 25% and 75% of the FVC.
|
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
|
|
Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Prazo: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
|
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
|
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
|
|
Annualized Rate of Loss of Asthma Control (LOAC) Event During The 52-Week Treatment Period: ITT Population
Prazo: Baseline to Week 52
|
LOAC was defined as any of the following: >=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS >=4 times the dose at randomization; use of systemic corticosteroids for >=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated.
|
Baseline to Week 52
|
|
Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population
Prazo: Baseline up to Week 52
|
The time to first severe exacerbation was defined as follows: date of the first event - randomization date +1.
For participants who had no event on or before Visit 18 (Week 52) or last contact date, the time was censored at the date of Visit 18 or the last contact date, whichever was earlier.
The median time to first severe exacerbation was not estimated; therefore, the probability of severe exacerbation at Weeks 12, 24, 36, and 52, are presented as the descriptive statistics.
|
Baseline up to Week 52
|
|
Time to First LOAC Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population
Prazo: Baseline up to Week 52
|
The time to first LOAC event was defined as follows: date of the first event - first dose date +1.
For participants who had no event on or before last dose date + 14 days or last contact date, the time was censored at the last dose date + 14 days or the last contact date, whichever was earlier.
|
Baseline up to Week 52
|
|
Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population
Prazo: Baseline, Weeks 2, 4, 8, 12, 36, and 52
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The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze.
Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment).
ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled).
Higher score indicated lower asthma control.
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Baseline, Weeks 2, 4, 8, 12, 36, and 52
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Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Prazo: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
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The ACQ-7 has 7 questions, the first 5 questions assess the most common asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze plus short-acting bronchodilator use, and FEV1 (pre-bronchodilator % predicted).
Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment).
Clinic staff scored the FEV1% predicted on a 7-point scale.
The questions were equally weighted and the ACQ-7 total score was mean of the scores of all 7 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled).
Higher score indicated lower asthma control.
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Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
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Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Prazo: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
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Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night.
It ranged from 0 to 4 as: 0= No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.
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Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
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Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Prazo: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
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Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day.
It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.
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Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
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Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Prazo: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
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Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.
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Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
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Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population
Prazo: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
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Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study.
The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded daily by the participants in an electronic diary/peak expiratory flow (PEF) meter.
In the case that Nebulizer solutions were used as an alternative delivery method, the nebulizer dose was converted to number of puffs as per following conversion factor: salbutamol/albuterol nebulizer solution (2.5 mg) corresponds to 4 puffs.
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Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52
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Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population
Prazo: Baseline, Weeks 12, 36, and 52
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The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma.
The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items).
Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment).
The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all).
Higher scores indicate better quality of life.
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Baseline, Weeks 12, 36, and 52
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Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population
Prazo: Baseline, Weeks 12, 24, 36, and 52
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EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS).
EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state.
EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable).
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Baseline, Weeks 12, 24, 36, and 52
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Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population
Prazo: Baseline, Weeks 12, 24, 36, and 52
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The HADS is a general scale to detect states of anxiety and depression already used and validated in asthma, which includes HADS-A and HADS-D subscales.
The instrument is comprised of 14 items: 7 related to anxiety (HADS-A) and 7 to depression (HADS-D).
Each item on the questionnaire is scored from 0-3.
The anxiety/depression score is the sum of the scores of the 7 related items; one can score between 0 and 21 for either anxiety or depression.
And the total score is the sum of the scores of the 14 items ranging from 0 (no symptoms) to 42 (severe symptoms), with higher scores indicating higher anxiety/depression complains.
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Baseline, Weeks 12, 24, 36, and 52
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Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis
Prazo: Baseline, Weeks 12, 24, 36, and 52
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The SNOT-22 is a validated measure of health related quality of life in sinonasal disease.
It is a 22 item questionnaire with each item assigned a score ranging from 0-5.
The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life.
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Baseline, Weeks 12, 24, 36, and 52
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Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis
Prazo: Baseline, Weeks 12, 24, 36, and 52
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RQLQ(S)+12 is a self-administered questionnaire with standardized activities developed to measure health-related quality of life signs and symptoms that are most problematic in those 12 to 75 years of age, as a result of perennial or seasonal allergic rhinitis.
There are 28 items on RQLQ(S) in 7 domains: activities (3 items), sleep (3 items), non-nose/eye symptoms (7 items), practical problems (3 items), nasal symptoms (4 items), eye symptoms (4 items) and emotional (4 items).
RQLQ(S)+12 responses are based on 7-point likert scale with responses ranging from 0 (not troubled) to 6 (extremely troubled).
Individual items within RQLQ(S)+12 are equally weighted.
The overall score is calculated as the mean score of all items.
Higher scores indicated more health-related quality of life impairment (lower scores better).
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Baseline, Weeks 12, 24, 36, and 52
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.
- Hamilton JD, Harel S, Swanson BN, Brian W, Chen Z, Rice MS, Amin N, Ardeleanu M, Radin A, Shumel B, Ruddy M, Patel N, Pirozzi G, Mannent L, Graham NMH. Dupilumab suppresses type 2 inflammatory biomarkers across multiple atopic, allergic diseases. Clin Exp Allergy. 2021 Jul;51(7):915-931. doi: 10.1111/cea.13954. Epub 2021 Jun 26.
- Castro M, Corren J, Pavord ID, Maspero J, Wenzel S, Rabe KF, Busse WW, Ford L, Sher L, FitzGerald JM, Katelaris C, Tohda Y, Zhang B, Staudinger H, Pirozzi G, Amin N, Ruddy M, Akinlade B, Khan A, Chao J, Martincova R, Graham NMH, Hamilton JD, Swanson BN, Stahl N, Yancopoulos GD, Teper A. Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med. 2018 Jun 28;378(26):2486-2496. doi: 10.1056/NEJMoa1804092. Epub 2018 May 21.
- Bansal A, Simpson EL, Paller AS, Siegfried EC, Blauvelt A, de Bruin-Weller M, Corren J, Sher L, Guttman-Yassky E, Chen Z, Daizadeh N, Kamal MA, Shumel B, Mina-Osorio P, Mannent L, Patel N, Graham NMH, Khokhar FA, Ardeleanu M. Conjunctivitis in Dupilumab Clinical Trials for Adolescents with Atopic Dermatitis or Asthma. Am J Clin Dermatol. 2021 Jan;22(1):101-115. doi: 10.1007/s40257-020-00577-1.
- Geng B, Bachert C, Busse WW, Gevaert P, Lee SE, Niederman MS, Chen Z, Lu X, Khokhar FA, Kapoor U, Pandit-Abid N, Jacob-Nara JA, Rowe PJ, Deniz Y, Ortiz B. Respiratory Infections and Anti-Infective Medication Use From Phase 3 Dupilumab Respiratory Studies. J Allergy Clin Immunol Pract. 2022 Mar;10(3):732-741. doi: 10.1016/j.jaip.2021.12.006. Epub 2021 Dec 22.
- Tohda Y, Matsumoto H, Miyata M, Taguchi Y, Ueyama M, Joulain F, Arakawa I. Cost-effectiveness analysis of dupilumab among patients with oral corticosteroid-dependent uncontrolled severe asthma in Japan. J Asthma. 2022 Nov;59(11):2162-2173. doi: 10.1080/02770903.2021.1996596. Epub 2021 Dec 8.
- Bourdin A, Virchow JC, Papi A, Lugogo NL, Bardin P, Antila M, Halpin DMG, Daizadeh N, Djandji M, Ortiz B, Jacob-Nara JA, Gall R, Deniz Y, Rowe PJ. Dupilumab efficacy in subgroups of type 2 asthma with high-dose inhaled corticosteroids at baseline. Respir Med. 2022 Oct;202:106938. doi: 10.1016/j.rmed.2022.106938. Epub 2022 Aug 11.
- Papi A, Corren J, Castro M, Domingo C, Rogers L, Chapman KR, Jackson DJ, Daizadeh N, Pandit-Abid N, Gall R, Jacob-Nara JA, Rowe PJ, Deniz Y, Ortiz B. Dupilumab reduced impact of severe exacerbations on lung function in patients with moderate-to-severe type 2 asthma. Allergy. 2023 Jan;78(1):233-243. doi: 10.1111/all.15456. Epub 2022 Aug 9.
- Rabe KF, Pavord ID, Castro M, Wechsler ME, Daizadeh N, Kapoor U, Ortiz B, Radwan A, Johnson RR, Rowe PJ, Deniz Y, Jacob-Nara JA. Dupilumab efficacy and safety in patients with asthma and blood eosinophils >/=500 cells.microL-1. Eur Respir J. 2022 Jun 23;59(6):2102577. doi: 10.1183/13993003.02577-2021. Print 2022 Jun.
- Rhee CK, Park JW, Park HW, Cho YS. Effect of Dupilumab in Korean Patients With Uncontrolled Moderate-to-Severe Asthma: A LIBERTY ASTHMA QUEST Sub-analysis. Allergy Asthma Immunol Res. 2022 Mar;14(2):182-195. doi: 10.4168/aair.2022.14.2.182.
- Busse WW, Paggiaro P, Munoz X, Casale TB, Castro M, Canonica GW, Douglass JA, Tohda Y, Daizadeh N, Ortiz B, Pandit-Abid N. Impact of baseline patient characteristics on dupilumab efficacy in type 2 asthma. Eur Respir J. 2021 Oct 7;58(4):2004605. doi: 10.1183/13993003.04605-2020. Print 2021 Oct.
- Corren J, Katelaris CH, Castro M, Maspero JF, Ford LB, Halpin DMG, Rice MS, Radwan A, Deniz Y, Rowe PJ, Teper A, Djandji M. Effect of exacerbation history on clinical response to dupilumab in moderate-to-severe uncontrolled asthma. Eur Respir J. 2021 Oct 28;58(4):2004498. doi: 10.1183/13993003.04498-2020. Print 2021 Oct.
- Busse WW, Wenzel SE, Casale TB, FitzGerald JM, Rice MS, Daizadeh N, Deniz Y, Patel N, Harel S, Rowe PJ, Graham NMH, O'Riordan T, Pavord ID. Baseline FeNO as a prognostic biomarker for subsequent severe asthma exacerbations in patients with uncontrolled, moderate-to-severe asthma receiving placebo in the LIBERTY ASTHMA QUEST study: a post-hoc analysis. Lancet Respir Med. 2021 Oct;9(10):1165-1173. doi: 10.1016/S2213-2600(21)00124-7. Epub 2021 Jun 25.
- Maspero JF, FitzGerald JM, Pavord ID, Rice MS, Maroni J, Rowe PJ, Pirozzi G, Amin N, Ruddy M, Graham NMH, Teper A, Hardin M. Dupilumab efficacy in adolescents with uncontrolled, moderate-to-severe asthma: LIBERTY ASTHMA QUEST. Allergy. 2021 Aug;76(8):2621-2624. doi: 10.1111/all.14872. Epub 2021 May 10. No abstract available.
- Bourdin A, Papi AA, Corren J, Virchow JC, Rice MS, Deniz Y, Djandji M, Rowe P, Pavord ID. Dupilumab is effective in type 2-high asthma patients receiving high-dose inhaled corticosteroids at baseline. Allergy. 2021 Jan;76(1):269-280. doi: 10.1111/all.14611. Epub 2020 Oct 21.
- Tohda Y, Nakamura Y, Fujisawa T, Ebisawa M, Arima K, Miyata M, Takahashi Y, Rice MS, Deniz Y, Rowe P, Patel N, Graham NMH, Teper A. Dupilumab efficacy and safety in Japanese patients with uncontrolled, moderate-to-severe asthma in the phase 3 LIBERTY ASTHMA QUEST study. Allergol Int. 2020 Oct;69(4):578-587. doi: 10.1016/j.alit.2020.04.002. Epub 2020 May 20.
- Corren J, Castro M, O'Riordan T, Hanania NA, Pavord ID, Quirce S, Chipps BE, Wenzel SE, Thangavelu K, Rice MS, Harel S, Jagerschmidt A, Khan AH, Kamat S, Maroni J, Rowe P, Lu Y, Amin N, Pirozzi G, Ruddy M, Graham NMH, Teper A. Dupilumab Efficacy in Patients with Uncontrolled, Moderate-to-Severe Allergic Asthma. J Allergy Clin Immunol Pract. 2020 Feb;8(2):516-526. doi: 10.1016/j.jaip.2019.08.050. Epub 2019 Sep 12.
- Maspero JF, Katelaris CH, Busse WW, Castro M, Corren J, Chipps BE, Peters AT, Pavord ID, Ford LB, Sher L, Rabe KF, Rice MS, Rowe P, Lu Y, Harel S, Jagerschmidt A, Khan AH, Kamat S, Pirozzi G, Amin N, Ruddy M, Graham NMH, Mannent LP, Teper A. Dupilumab Efficacy in Uncontrolled, Moderate-to-Severe Asthma with Self-Reported Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2020 Feb;8(2):527-539.e9. doi: 10.1016/j.jaip.2019.07.016. Epub 2019 Jul 24.
- Corren J, Castro M, Chanez P, Fabbri L, Joish VN, Amin N, Graham NMH, Mastey V, Abbe A, Taniou C, Mahajan P, Teper A, Pirozzi G, Eckert L. Dupilumab improves symptoms, quality of life, and productivity in uncontrolled persistent asthma. Ann Allergy Asthma Immunol. 2019 Jan;122(1):41-49.e2. doi: 10.1016/j.anai.2018.08.005. Epub 2018 Aug 21.
- Busse WW, Maspero JF, Rabe KF, Papi A, Wenzel SE, Ford LB, Pavord ID, Zhang B, Staudinger H, Pirozzi G, Amin N, Akinlade B, Eckert L, Chao J, Graham NMH, Teper A. Liberty Asthma QUEST: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Dupilumab Efficacy/Safety in Patients with Uncontrolled, Moderate-to-Severe Asthma. Adv Ther. 2018 May;35(5):737-748. doi: 10.1007/s12325-018-0702-4. Epub 2018 May 3.
- Weinstein SF, Katial R, Jayawardena S, Pirozzi G, Staudinger H, Eckert L, Joish VN, Amin N, Maroni J, Rowe P, Graham NMH, Teper A. Efficacy and safety of dupilumab in perennial allergic rhinitis and comorbid asthma. J Allergy Clin Immunol. 2018 Jul;142(1):171-177.e1. doi: 10.1016/j.jaci.2017.11.051. Epub 2018 Jan 31.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
27 de abril de 2015
Conclusão Primária (Real)
29 de julho de 2017
Conclusão do estudo (Real)
23 de novembro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
8 de abril de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de abril de 2015
Primeira postagem (Estimativa)
13 de abril de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
23 de outubro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de outubro de 2018
Última verificação
1 de junho de 2018
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Respiratórias
- Doenças do sistema imunológico
- Doenças pulmonares
- Hipersensibilidade, Imediata
- Doenças brônquicas
- Doenças Pulmonares Obstrutivas
- Hipersensibilidade Respiratória
- Hipersensibilidade
- Asma
- Efeitos Fisiológicos das Drogas
- Agentes Adrenérgicos
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Autônomos
- Agentes do Sistema Nervoso Periférico
- Agonistas Adrenérgicos
- Agentes broncodilatadores
- Agentes Antiasmáticos
- Agentes do Sistema Respiratório
- Agentes de Controle Reprodutivo
- Agonistas de Receptores Beta-2 Adrenérgicos
- Beta-Agonistas Adrenérgicos
- Tocolíticos
- Salbutamol
Outros números de identificação do estudo
- EFC13579
- 2014-004940-36 (Número EudraCT)
- U1111-1163-1293 (Outro identificador: UTN)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .