SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma. (AUSTRI)

August 2, 2018 updated by: GlaxoSmithKline

SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects With Asthma

The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.

ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.

Study Overview

Detailed Description

Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in January of 2016. This is the final update, as this study is complete.

Study Type

Interventional

Enrollment (Actual)

11751

Phase

  • Phase 4

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

      • Buenos Aires, Argentina, 1425
        • GSK Investigational Site
      • Buenos Aires, Argentina, 1406
        • GSK Investigational Site
      • Buenos Aires, Argentina, 1602
        • GSK Investigational Site
      • Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
        • GSK Investigational Site
      • La Plata, Argentina, B1902COS
        • GSK Investigational Site
      • Lanús, Argentina, B1824KAJ
        • GSK Investigational Site
      • Mendoza, Argentina, 5500
        • GSK Investigational Site
      • Rosario, Argentina, S2000BRH
        • GSK Investigational Site
    • Buenos Aires
      • Derqui, Pilar, Buenos Aires, Argentina, B1629AHJ
        • GSK Investigational Site
      • Nueve de Julio, Buenos Aires, Argentina, B6500BWQ
        • GSK Investigational Site
      • San Martin, Buenos Aires, Argentina, 1650
        • GSK Investigational Site
    • Entre Ríos
      • Concepcion del Uruguay, Entre Ríos, Argentina, 3260
        • GSK Investigational Site
      • Parana, Entre Ríos, Argentina, E3100BHK
        • GSK Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000JKR
        • GSK Investigational Site
    • Tucumán
      • San Miguel de Tucuman, Tucumán, Argentina, 4000
        • GSK Investigational Site
      • Parkville, Australia, 3052
        • GSK Investigational Site
    • New South Wales
      • Broadmeadow, New South Wales, Australia, 2292
        • GSK Investigational Site
      • Randwick, New South Wales, Australia, 2031
        • GSK Investigational Site
      • Westmead, New South Wales, Australia, 2145
        • GSK Investigational Site
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • GSK Investigational Site
      • Redcliffe, Queensland, Australia, 4020
        • GSK Investigational Site
      • Woolloongabba, Queensland, Australia, 4102
        • GSK Investigational Site
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • GSK Investigational Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • GSK Investigational Site
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • GSK Investigational Site
      • Feldkirch, Austria, 6800
        • GSK Investigational Site
      • Salzburg, Austria, A-5020
        • GSK Investigational Site
      • Vienna, Austria, A-1030
        • GSK Investigational Site
      • Wels, Austria, 4600
        • GSK Investigational Site
      • Wien, Austria, 1230
        • GSK Investigational Site
      • Brussels, Belgium, 1000
        • GSK Investigational Site
      • Bruxelles, Belgium, 1200
        • GSK Investigational Site
      • Bruxelles, Belgium, 1070
        • GSK Investigational Site
      • Hamois (Natoye), Belgium, 5360
        • GSK Investigational Site
      • Jambes, Belgium, 5100
        • GSK Investigational Site
      • Leuven, Belgium, 3000
        • GSK Investigational Site
      • Montigny-Le-Tilleul, Belgium, 6110
        • GSK Investigational Site
      • Blagoevgrad, Bulgaria, 2700
        • GSK Investigational Site
      • Pazardjik, Bulgaria, 4400
        • GSK Investigational Site
      • Plovdiv, Bulgaria, 4000
        • GSK Investigational Site
      • Sliven, Bulgaria, 8800
        • GSK Investigational Site
      • Sofia, Bulgaria, 1606
        • GSK Investigational Site
      • Sofia, Bulgaria, 1000
        • GSK Investigational Site
      • Sofia, Bulgaria, 1463
        • GSK Investigational Site
      • Troyan, Bulgaria, 5600
        • GSK Investigational Site
      • Varna, Bulgaria, 9000
        • GSK Investigational Site
      • Veliko Tarnovo, Bulgaria, 5000
        • GSK Investigational Site
      • Vidin, Bulgaria, 3700
        • GSK Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada, T5A 4L8
        • GSK Investigational Site
      • Edmonton, Alberta, Canada, T5X 3N5
        • GSK Investigational Site
    • British Columbia
      • Surrey, British Columbia, Canada, V4H 2H9
        • GSK Investigational Site
      • Surrey, British Columbia, Canada, V35 2N6
        • GSK Investigational Site
      • Victoria, British Columbia, Canada, V8V3N7
        • GSK Investigational Site
    • Ontario
      • Brampton, Ontario, Canada, L6T3J1
        • GSK Investigational Site
      • Fort Erie, Ontario, Canada, L2A 1X3
        • GSK Investigational Site
      • Grimsby, Ontario, Canada, L3M 1P3
        • GSK Investigational Site
      • Kingston, Ontario, Canada, K7L 2V6
        • GSK Investigational Site
      • Mississauga, Ontario, Canada, L4T 4J2
        • GSK Investigational Site
      • Newmarket, Ontario, Canada, L3Y 5G8
        • GSK Investigational Site
      • Oshawa, Ontario, Canada, L1H 7K4
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5T 3A9
        • GSK Investigational Site
      • Windsor, Ontario, Canada, N8X 2G1
        • GSK Investigational Site
      • Santiago, Chile, 7560994
        • GSK Investigational Site
      • Valdivia, Chile, 5090146
        • GSK Investigational Site
      • Viña del Mar, Chile, 2570017
        • GSK Investigational Site
      • Viña del Mar, Chile, 2570017.
        • GSK Investigational Site
    • Región De La Araucania
      • Temuco, Región De La Araucania, Chile, 4800798
        • GSK Investigational Site
    • Valparaíso
      • Valparaiso, Valparaíso, Chile, 2341131
        • GSK Investigational Site
      • Bogota, Colombia
        • GSK Investigational Site
      • Bucaramanga, Colombia
        • GSK Investigational Site
      • Cakovec, Croatia, 40000
        • GSK Investigational Site
      • Senj, Croatia, 53270
        • GSK Investigational Site
      • Zadar, Croatia, 23000
        • GSK Investigational Site
      • Zagreb, Croatia, 10000
        • GSK Investigational Site
      • Havlickuv brod, Czechia, 580 01
        • GSK Investigational Site
      • Hlucin, Czechia, 748 01
        • GSK Investigational Site
      • Jaromer, Czechia, 551 01
        • GSK Investigational Site
      • Kyjov, Czechia, 697 33
        • GSK Investigational Site
      • Plzen, Czechia, 301 00
        • GSK Investigational Site
      • Plzen, Czechia, 323 00
        • GSK Investigational Site
      • Praha 1, Czechia, 110 00
        • GSK Investigational Site
      • Praha 13, Czechia, 158 00
        • GSK Investigational Site
      • Praha 4, Czechia, 140 00
        • GSK Investigational Site
      • Praha 6, Czechia, 169 00
        • GSK Investigational Site
      • Praha 6, Czechia, 163 00
        • GSK Investigational Site
      • Svitavy, Czechia, 568 25
        • GSK Investigational Site
      • Tremosna, Czechia, 330 11
        • GSK Investigational Site
      • Copenhagen, Denmark, 2400
        • GSK Investigational Site
      • Rosklide, Denmark, DK-4000
        • GSK Investigational Site
      • Berlin, Germany, 13086
        • GSK Investigational Site
      • Berlin, Germany, 13353
        • GSK Investigational Site
      • Berlin, Germany, 13187
        • GSK Investigational Site
      • Berlin, Germany, 14050
        • GSK Investigational Site
      • Berlin, Germany, 10629
        • GSK Investigational Site
      • Berlin, Germany, 10787
        • GSK Investigational Site
      • Berlin, Germany, 12157
        • GSK Investigational Site
      • Berlin, Germany, 13156
        • GSK Investigational Site
      • Berlin, Germany, 12099
        • GSK Investigational Site
      • Berlin, Germany, 12165
        • GSK Investigational Site
      • Hamburg, Germany, 22143
        • GSK Investigational Site
      • Hamburg, Germany, 22335
        • GSK Investigational Site
      • Hamburg, Germany, 20354
        • GSK Investigational Site
      • Hamburg, Germany, 22767
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Bruchsal, Baden-Wuerttemberg, Germany, 76646
        • GSK Investigational Site
      • Deggingen, Baden-Wuerttemberg, Germany, 73326
        • GSK Investigational Site
      • Mannheim, Baden-Wuerttemberg, Germany, 68161
        • GSK Investigational Site
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • GSK Investigational Site
    • Bayern
      • Aschaffenburg, Bayern, Germany, 63739
        • GSK Investigational Site
      • Augsburg, Bayern, Germany, 86150
        • GSK Investigational Site
      • Augsburg, Bayern, Germany, 86156
        • GSK Investigational Site
      • Bad Woerrishofen, Bayern, Germany, 86825
        • GSK Investigational Site
      • Feldkirchen, Bayern, Germany, 83620
        • GSK Investigational Site
      • Fuerth, Bayern, Germany, 90762
        • GSK Investigational Site
      • Gars Am Inn, Bayern, Germany, 83536
        • GSK Investigational Site
      • Georgensgmuend, Bayern, Germany, 91166
        • GSK Investigational Site
      • Grossheirath, Bayern, Germany, 96269
        • GSK Investigational Site
      • Hoechstadt, Bayern, Germany, 91315
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80335
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80337
        • GSK Investigational Site
      • Neuoetting, Bayern, Germany, 84524
        • GSK Investigational Site
      • Vilshofen, Bayern, Germany, 94474
        • GSK Investigational Site
      • Weissenhorn, Bayern, Germany, 89264
        • GSK Investigational Site
    • Brandenburg
      • Potsdam, Brandenburg, Germany, 14478
        • GSK Investigational Site
      • Potsdam, Brandenburg, Germany, 14467
        • GSK Investigational Site
      • Rathenow, Brandenburg, Germany, 14712
        • GSK Investigational Site
    • Hessen
      • Bad Arolsen, Hessen, Germany, 34454
        • GSK Investigational Site
      • Bensheim, Hessen, Germany, 64625
        • GSK Investigational Site
      • Frankenberg, Hessen, Germany, 35066
        • GSK Investigational Site
      • Frankfurt, Hessen, Germany, 60318
        • GSK Investigational Site
      • Frankfurt/Main, Hessen, Germany, 60320
        • GSK Investigational Site
      • Lahnau, Hessen, Germany, 35633
        • GSK Investigational Site
      • Offenbach, Hessen, Germany, 63071
        • GSK Investigational Site
      • Rodgau, Hessen, Germany, 63110
        • GSK Investigational Site
      • Ruesselsheim, Hessen, Germany, 65428
        • GSK Investigational Site
      • Schwalmstadt, Hessen, Germany, 34613
        • GSK Investigational Site
    • Niedersachsen
      • Bad Pyrmont, Niedersachsen, Germany, 31812
        • GSK Investigational Site
      • Goettingen, Niedersachsen, Germany, 37081
        • GSK Investigational Site
      • Wolfsburg, Niedersachsen, Germany, 38448
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bad Lippspringe, Nordrhein-Westfalen, Germany, 33175
        • GSK Investigational Site
      • Beckum, Nordrhein-Westfalen, Germany, 59269
        • GSK Investigational Site
      • Bergisch Gladbach, Nordrhein-Westfalen, Germany, 51429
        • GSK Investigational Site
      • Bochum, Nordrhein-Westfalen, Germany, 44791
        • GSK Investigational Site
      • Bonn, Nordrhein-Westfalen, Germany, 53119
        • GSK Investigational Site
      • Bonn, Nordrhein-Westfalen, Germany, 53123
        • GSK Investigational Site
      • Detmold, Nordrhein-Westfalen, Germany, 32756
        • GSK Investigational Site
      • Engelskirchen, Nordrhein-Westfalen, Germany, 51766
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Germany, 45359
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Germany, 45136
        • GSK Investigational Site
      • Hagen, Nordrhein-Westfalen, Germany, 58089
        • GSK Investigational Site
      • Herne, Nordrhein-Westfalen, Germany, 44629
        • GSK Investigational Site
      • Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
        • GSK Investigational Site
      • Krefeld, Nordrhein-Westfalen, Germany, 47798
        • GSK Investigational Site
      • Muenster, Nordrhein-Westfalen, Germany, 48149
        • GSK Investigational Site
      • Neuss, Nordrhein-Westfalen, Germany, 41469
        • GSK Investigational Site
      • Ratingen, Nordrhein-Westfalen, Germany, 40878
        • GSK Investigational Site
      • Solingen, Nordrhein-Westfalen, Germany, 42651
        • GSK Investigational Site
      • Telgte, Nordrhein-Westfalen, Germany, 48291
        • GSK Investigational Site
      • Witten, Nordrhein-Westfalen, Germany, 58452
        • GSK Investigational Site
      • Wuppertal, Nordrhein-Westfalen, Germany, 42117
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Koblenz, Rheinland-Pfalz, Germany, 56068
        • GSK Investigational Site
      • Raubach, Rheinland-Pfalz, Germany, 56316
        • GSK Investigational Site
      • Rhaunen, Rheinland-Pfalz, Germany, 55624
        • GSK Investigational Site
    • Saarland
      • Dillingen, Saarland, Germany, 66763
        • GSK Investigational Site
      • Saarbruecken, Saarland, Germany, 66111
        • GSK Investigational Site
    • Sachsen
      • Auerbach, Sachsen, Germany, 08209
        • GSK Investigational Site
      • Boehlen, Sachsen, Germany, 04564
        • GSK Investigational Site
      • Delitzsch, Sachsen, Germany, 04509
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04357
        • GSK Investigational Site
      • Meissen, Sachsen, Germany, 1662
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Teuchern, Sachsen-Anhalt, Germany, 6682
        • GSK Investigational Site
      • Zerbst, Sachsen-Anhalt, Germany, 39261
        • GSK Investigational Site
    • Schleswig-Holstein
      • Klappholz, Schleswig-Holstein, Germany, 24860
        • GSK Investigational Site
      • Reinfeld, Schleswig-Holstein, Germany, 23858
        • GSK Investigational Site
      • Baja, Hungary, 6500
        • GSK Investigational Site
      • Balassagyarmat, Hungary, 2660
        • GSK Investigational Site
      • Budapest, Hungary, 1089
        • GSK Investigational Site
      • Budapest, Hungary, 1101
        • GSK Investigational Site
      • Budapest, Hungary, 1117
        • GSK Investigational Site
      • Budapest, Hungary, 1195
        • GSK Investigational Site
      • Budapest, Hungary, 1221
        • GSK Investigational Site
      • Debrecen, Hungary, 4026
        • GSK Investigational Site
      • Kaposvár, Hungary, 7400
        • GSK Investigational Site
      • Komló, Hungary, 7300
        • GSK Investigational Site
      • Mosonmagyaróvár, Hungary, 9200
        • GSK Investigational Site
      • Nagykanizsa, Hungary, 08800
        • GSK Investigational Site
      • Rackeve, Hungary, 2300
        • GSK Investigational Site
      • Siófok, Hungary, 8600
        • GSK Investigational Site
      • Szolnok, Hungary, 5000
        • GSK Investigational Site
      • Denpasar, Indonesia, 80114
        • GSK Investigational Site
      • Depok Timur, Indonesia, 16411
        • GSK Investigational Site
      • Jakarta, Indonesia, 10430
        • GSK Investigational Site
      • Jakarta, Indonesia, 12430
        • GSK Investigational Site
      • Jakarta, Indonesia, 13230
        • GSK Investigational Site
      • Jakarta, Indonesia, 13630
        • GSK Investigational Site
      • Malang, Indonesia, 65100
        • GSK Investigational Site
      • Medan, Indonesia, 20111
        • GSK Investigational Site
      • Palembang, Indonesia, 30126
        • GSK Investigational Site
      • Semarang, Indonesia, 50242
        • GSK Investigational Site
      • Surakarta, Indonesia, 57126
        • GSK Investigational Site
      • Brescia, Italy, 25123
        • GSK Investigational Site
      • Messina, Italy, 98123
        • GSK Investigational Site
      • Milano, Italy, 20122
        • GSK Investigational Site
      • Milano, Italy, 20157
        • GSK Investigational Site
      • Milano, Italy, 20142
        • GSK Investigational Site
      • Monza, Italy, 20052
        • GSK Investigational Site
      • Roma, Italy, 00168
        • GSK Investigational Site
      • Sesto San Giovanni, Italy, 20099
        • GSK Investigational Site
    • Emilia-Romagna
      • Parma, Emilia-Romagna, Italy, 43125
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italy, 00165
        • GSK Investigational Site
      • Roma, Lazio, Italy, 00135
        • GSK Investigational Site
      • Roma, Lazio, Italy, 00157
        • GSK Investigational Site
    • Liguria
      • Arenzano, Liguria, Italy, 16011
        • GSK Investigational Site
    • Lombardia
      • Bergamo, Lombardia, Italy, 24128
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20157
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20162
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20129
        • GSK Investigational Site
      • Pavia, Lombardia, Italy, 27100
        • GSK Investigational Site
    • Sicilia
      • Catania, Sicilia, Italy, 95125
        • GSK Investigational Site
      • Palermo, Sicilia, Italy, 90146
        • GSK Investigational Site
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • GSK Investigational Site
      • Bucheon, Korea, Republic of, 420-717
        • GSK Investigational Site
      • Bucheon-si,, Korea, Republic of, 420-767
        • GSK Investigational Site
      • Busan, Korea, Republic of, 602-715
        • GSK Investigational Site
      • Chuncheon, Korea, Republic of, 200-722
        • GSK Investigational Site
      • Gwangju, Korea, Republic of, 501-757
        • GSK Investigational Site
      • Incheon, Korea, Republic of, 403-720
        • GSK Investigational Site
      • Incheon, Korea, Republic of, 402-751
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 137-701
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 136-705
        • GSK Investigational Site
      • Kuldiga, Latvia, LV - 3301
        • GSK Investigational Site
      • Riga, Latvia, LV 1003
        • GSK Investigational Site
      • Riga, Latvia, LV1038
        • GSK Investigational Site
      • Riga, Latvia, LV-1004
        • GSK Investigational Site
      • Tukums, Latvia, LV - 3101
        • GSK Investigational Site
      • Kaunas, Lithuania, LT-50009
        • GSK Investigational Site
      • Kaunas, Lithuania, LT-50128
        • GSK Investigational Site
      • Kaunas, Lithuania, LT-47144
        • GSK Investigational Site
      • Kaunas, Lithuania, LT-49456
        • GSK Investigational Site
      • Klaipeda, Lithuania, LT-92288
        • GSK Investigational Site
      • Siauliai, Lithuania, LT-76231
        • GSK Investigational Site
      • Utena, Lithuania, LT-28151
        • GSK Investigational Site
      • Vilnius, Lithuania, LT-08661
        • GSK Investigational Site
      • Vilnius, Lithuania, LT-01117
        • GSK Investigational Site
      • Vilnius, Lithuania, LT -10207
        • GSK Investigational Site
      • Vilnius, Lithuania, LT-04338
        • GSK Investigational Site
      • Vilnius, Lithuania, LT-08406
        • GSK Investigational Site
      • Alor Setar, Malaysia, 05460
        • GSK Investigational Site
      • Kota Bharu, Malaysia, 15886
        • GSK Investigational Site
      • Kuala Pilah, Malaysia, 72000
        • GSK Investigational Site
      • Selangor, Malaysia, 68100
        • GSK Investigational Site
      • Sungai Buloh, Malaysia, 47000
        • GSK Investigational Site
      • Chihuahua, Mexico, 31020
        • GSK Investigational Site
      • Huixquilucan, Mexico, 52763
        • GSK Investigational Site
      • Monterrey, Mexico, 64710
        • GSK Investigational Site
      • Monterrey, Mexico, 64718
        • GSK Investigational Site
      • Zapopan, Mexico, 45128
        • GSK Investigational Site
    • Aguascalientes
      • Aguascalientes, Ags, Aguascalientes, Mexico, 20127
        • GSK Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • GSK Investigational Site
      • Lima, Peru, Lima 1
        • GSK Investigational Site
      • Lima, Peru, Lima 18
        • GSK Investigational Site
      • Lima, Peru, L 33
        • GSK Investigational Site
      • San Borja, Lima, Peru, L36
        • GSK Investigational Site
      • Dasmariñas, Cavite, Philippines, 4114
        • GSK Investigational Site
      • Davao, Philippines, 8000
        • GSK Investigational Site
      • Las Pinas, Philippines, 1470
        • GSK Investigational Site
      • Los Banos, Philippines, 4030
        • GSK Investigational Site
      • Pulilan, Philippines, 3005
        • GSK Investigational Site
      • Quezon City, Philippines, 1100
        • GSK Investigational Site
      • Bielsko-Biala, Poland, 43-300
        • GSK Investigational Site
      • Brzesko, Poland, 32-800
        • GSK Investigational Site
      • Bydgoszcz, Poland, 85-168
        • GSK Investigational Site
      • Bystra, Poland, 43-360
        • GSK Investigational Site
      • Cieszyn, Poland, 43-400
        • GSK Investigational Site
      • Dębica, Poland, 39 - 200
        • GSK Investigational Site
      • Elblag, Poland, 82-300
        • GSK Investigational Site
      • Gdansk, Poland, 84-462
        • GSK Investigational Site
      • Gdanska, Poland, 80-433
        • GSK Investigational Site
      • Glucholazy, Poland, 41-340
        • GSK Investigational Site
      • Jelenia Gora, Poland, 58-500
        • GSK Investigational Site
      • Krakow, Poland, 31-202
        • GSK Investigational Site
      • Libiaz, Poland, 32-590
        • GSK Investigational Site
      • Lodz, Poland, 93-513
        • GSK Investigational Site
      • Lodz, Poland, 90-302
        • GSK Investigational Site
      • Lodz, Poland, 90-430
        • GSK Investigational Site
      • Lodz, Poland, 91-357
        • GSK Investigational Site
      • Lubin, Poland, 59-300
        • GSK Investigational Site
      • Lublin, Poland, 20-093
        • GSK Investigational Site
      • Olsztyn, Poland, 10-357
        • GSK Investigational Site
      • Poznan, Poland, 60-214
        • GSK Investigational Site
      • Radomsko, Poland, 97-500
        • GSK Investigational Site
      • Ruda Slaska, Poland, 41-709
        • GSK Investigational Site
      • Rudka, Poland, 05-320
        • GSK Investigational Site
      • Rzeszow, Poland, 35-241
        • GSK Investigational Site
      • Sandomierz, Poland, 27-600
        • GSK Investigational Site
      • Sopot, Poland, 81-741
        • GSK Investigational Site
      • Szczecin, Poland, 70-111
        • GSK Investigational Site
      • Warszawa, Poland, 01-138
        • GSK Investigational Site
      • Warszawa, Poland, 04-141
        • GSK Investigational Site
      • Warszawa, Poland, 01-157
        • GSK Investigational Site
      • Wodzislaw Slaski, Poland, 44-300
        • GSK Investigational Site
      • Wolomin, Poland, 05-200
        • GSK Investigational Site
      • Wroclaw, Poland, 54-239
        • GSK Investigational Site
      • Wroclaw, Poland, 53-301
        • GSK Investigational Site
      • Zabrze, Poland, 41-800
        • GSK Investigational Site
      • Zabrze, Poland, 41 - 800
        • GSK Investigational Site
      • Zgierz, Poland, 95-100
        • GSK Investigational Site
      • Brasov, Romania, 500074
        • GSK Investigational Site
      • Cluj-Napoca, Romania, 400371
        • GSK Investigational Site
      • Sibiu, Romania, 550166
        • GSK Investigational Site
      • Chelyabinsk, Russian Federation, 454021
        • GSK Investigational Site
      • Kemerovo, Russian Federation, 650000
        • GSK Investigational Site
      • Kemerovo, Russian Federation, 650002
        • GSK Investigational Site
      • Kirov, Russian Federation, 610027
        • GSK Investigational Site
      • Krasnodar, Russian Federation, 350063
        • GSK Investigational Site
      • Krasnoyarsk, Russian Federation, 660022
        • GSK Investigational Site
      • Moscow, Russian Federation, 123182
        • GSK Investigational Site
      • Moscow, Russian Federation, 125167
        • GSK Investigational Site
      • Moscow, Russian Federation, 127018
        • GSK Investigational Site
      • Moscow, Russian Federation, 125412
        • GSK Investigational Site
      • Moscow, Russian Federation, 117593
        • GSK Investigational Site
      • Moscow, Russian Federation, 115432
        • GSK Investigational Site
      • Moscow, Russian Federation, 119121
        • GSK Investigational Site
      • Moscow, Russian Federation, 125205
        • GSK Investigational Site
      • Moscow, Russian Federation, 110020
        • GSK Investigational Site
      • Novgorod, Russian Federation, 173008
        • GSK Investigational Site
      • Novosibirsk, Russian Federation, 630099
        • GSK Investigational Site
      • Novosibirsk, Russian Federation, 630087
        • GSK Investigational Site
      • Novosibirsk, Russian Federation, 630091
        • GSK Investigational Site
      • Novosibirsk, Russian Federation, 630051
        • GSK Investigational Site
      • Novosibirsk, Russian Federation, 630089
        • GSK Investigational Site
      • Orenburg, Russian Federation, 460018
        • GSK Investigational Site
      • Pyatigorsk, Russian Federation, 357538
        • GSK Investigational Site
      • Rostov-on-Don, Russian Federation, 344091
        • GSK Investigational Site
      • Ryazan, Russian Federation, 390026
        • GSK Investigational Site
      • Saint Petersburg, Russian Federation, 192212
        • GSK Investigational Site
      • Saint Petersburg, Russian Federation, 196657
        • GSK Investigational Site
      • Saint Petersburg, Russian Federation, 195067
        • GSK Investigational Site
      • Saint Petersburg, Russian Federation, 196084
        • GSK Investigational Site
      • Saint-Petersburg, Russian Federation, 194354
        • GSK Investigational Site
      • Saint-Petersburg, Russian Federation, 195112
        • GSK Investigational Site
      • Saratov, Russian Federation, 410018
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 197022
        • GSK Investigational Site
      • Tomsk, Russian Federation, 634063
        • GSK Investigational Site
      • Tomsk, Russian Federation, 634 050
        • GSK Investigational Site
      • Voronezh, Russian Federation, 394018
        • GSK Investigational Site
      • Yaroslavl, Russian Federation, 150003
        • GSK Investigational Site
      • Belgrade, Serbia, 11000
        • GSK Investigational Site
      • Belgrade, Serbia, 11080
        • GSK Investigational Site
      • Kosice, Slovakia, 040 01
        • GSK Investigational Site
      • Kralovsky Chlmec, Slovakia, 077 01
        • GSK Investigational Site
      • Levice, Slovakia, 934 01
        • GSK Investigational Site
      • Martin, Slovakia, 036 59
        • GSK Investigational Site
      • Sturovo, Slovakia, 943 11
        • GSK Investigational Site
      • Trnava, Slovakia, 917 01
        • GSK Investigational Site
      • Bellville, South Africa, 7531
        • GSK Investigational Site
      • Benoni, South Africa, 1501
        • GSK Investigational Site
      • Cape Town, South Africa, 7500
        • GSK Investigational Site
      • Cape Town, South Africa, 7700
        • GSK Investigational Site
      • Cape Town, South Africa, 7441
        • GSK Investigational Site
      • Cape Town, South Africa, 7570
        • GSK Investigational Site
      • Claremont, South Africa, 7708
        • GSK Investigational Site
      • Die Wilgers, South Africa, 0184
        • GSK Investigational Site
      • Durban, South Africa, 4001
        • GSK Investigational Site
      • Durban, South Africa, 4071
        • GSK Investigational Site
      • Gatesville, South Africa, 7764
        • GSK Investigational Site
      • Middelburg, South Africa, 1050
        • GSK Investigational Site
      • Pretoria, South Africa, 0002
        • GSK Investigational Site
      • Pretoria, South Africa, 0001
        • GSK Investigational Site
      • Somerset West, South Africa, 7130
        • GSK Investigational Site
      • Soweto, South Africa, 2013
        • GSK Investigational Site
      • Thabazimbi, South Africa
        • GSK Investigational Site
      • Welkom, South Africa, 9460
        • GSK Investigational Site
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6014
        • GSK Investigational Site
    • Gauteng
      • Cape Town, Gauteng, South Africa, 7505
        • GSK Investigational Site
      • Eloffsdal, Gauteng, South Africa, 0084
        • GSK Investigational Site
      • Krugersdorp, Gauteng, South Africa, 1752
        • GSK Investigational Site
      • Pretoria, Gauteng, South Africa, 0181
        • GSK Investigational Site
      • Barcelona, Spain, 08036
        • GSK Investigational Site
      • Barcelona, Spain, 08022
        • GSK Investigational Site
      • Barcelona, Spain, 8036
        • GSK Investigational Site
      • Basurto/Bilbao, Spain, 48013
        • GSK Investigational Site
      • Burgos, Spain, 09005
        • GSK Investigational Site
      • Canet De Mar - Barcelona, Spain, 08360
        • GSK Investigational Site
      • Cádiz, Spain, 10009
        • GSK Investigational Site
      • Elche, Spain, 12203
        • GSK Investigational Site
      • Illescas-Toledo, Spain, 45004
        • GSK Investigational Site
      • La Coruña, Spain, 15006
        • GSK Investigational Site
      • Lleida, Spain, 25198
        • GSK Investigational Site
      • Madrid, Spain, 28041
        • GSK Investigational Site
      • Madrid, Spain, 28046
        • GSK Investigational Site
      • Madrid, Spain, 28805
        • GSK Investigational Site
      • Majadahonda (Madrid), Spain, 28222
        • GSK Investigational Site
      • Mataro, Spain, 08303
        • GSK Investigational Site
      • Pozuelo De Alarcón/Madrid, Spain, 28223
        • GSK Investigational Site
      • Sabadell (Barcelona), Spain, 08208
        • GSK Investigational Site
      • Sagunto/Valencia, Spain, 46520
        • GSK Investigational Site
      • Sant Boi de Llobregat, Spain, 08830
        • GSK Investigational Site
      • Santiago de Compostela, Spain, 15706
        • GSK Investigational Site
      • Tarrasa, Barcelona, Spain, 08221
        • GSK Investigational Site
      • Torrelavega, Spain, 39300
        • GSK Investigational Site
      • Valencia, Spain, 46026
        • GSK Investigational Site
      • Valladolid, Spain, 47012
        • GSK Investigational Site
      • Vic (Barcelona), Spain, 08500
        • GSK Investigational Site
      • Kaohsiung, Taiwan, 833
        • GSK Investigational Site
      • Kaohsiung, Taiwan, 824
        • GSK Investigational Site
      • Keelung, Taiwan, 20401
        • GSK Investigational Site
      • Koahsiung, Taiwan, 81346
        • GSK Investigational Site
      • Putzu, Taiwan, 613
        • GSK Investigational Site
      • Taipei, Taiwan
        • GSK Investigational Site
      • Taipei, Taiwan, 220
        • GSK Investigational Site
      • Taipei, Taiwan, 106
        • GSK Investigational Site
      • Taipei, Taiwan, 115
        • GSK Investigational Site
      • Cherkassy, Ukraine, 18009
        • GSK Investigational Site
      • Dnipropetrovsk, Ukraine, 49027
        • GSK Investigational Site
      • Dnipropetrovsk, Ukraine, 49101
        • GSK Investigational Site
      • Donetsk, Ukraine, 83059
        • GSK Investigational Site
      • Ivano-Frankivsk, Ukraine, 76008
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61039
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61002
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61103
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61157
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61050
        • GSK Investigational Site
      • Kiev, Ukraine, 03680
        • GSK Investigational Site
      • Kryvyi Rih, Ukraine, 50082
        • GSK Investigational Site
      • Kyiv, Ukraine
        • GSK Investigational Site
      • Kyiv, Ukraine, 04201
        • GSK Investigational Site
      • Lviv, Ukraine, 79059
        • GSK Investigational Site
      • Odesa, Ukraine, 65117
        • GSK Investigational Site
      • Odesa, Ukraine, 65010
        • GSK Investigational Site
      • Odesa, Ukraine, 85038
        • GSK Investigational Site
      • Poltava, Ukraine, 36011
        • GSK Investigational Site
      • Simferopol, Ukraine, 95006
        • GSK Investigational Site
      • Sumy, Ukraine, 40022
        • GSK Investigational Site
      • Sumy, Ukraine, 40030
        • GSK Investigational Site
      • Sumy, Ukraine, 40031
        • GSK Investigational Site
      • Ternopil, Ukraine, 46000
        • GSK Investigational Site
      • Vinnytsia, Ukraine, 21018
        • GSK Investigational Site
      • Zaporizhzhia, Ukraine, 69600
        • GSK Investigational Site
      • Zaporizhzhya, Ukraine, 69001
        • GSK Investigational Site
      • Zhytomyr, Ukraine, 10002
        • GSK Investigational Site
      • Barry, United Kingdom, CF63 4AR
        • GSK Investigational Site
      • Bexhill-on-Sea, United Kingdom, TN40 1JJ
        • GSK Investigational Site
      • Chertsey, Surrey, United Kingdom, KT16 0PZ
        • GSK Investigational Site
      • Glasgow, United Kingdom, G12 0YN
        • GSK Investigational Site
      • Kent, United Kingdom, CT5 3QU
        • GSK Investigational Site
      • Leicester, United Kingdom, LE2 7LX
        • GSK Investigational Site
      • London, United Kingdom, E2 9JX
        • GSK Investigational Site
      • London, United Kingdom, E9 6SR
        • GSK Investigational Site
      • Merseyside, United Kingdom, CH41 0DD
        • GSK Investigational Site
      • Penzance, United Kingdom, TK19 7HX
        • GSK Investigational Site
      • Stoke on Trent, United Kingdom, ST4 6QG
        • GSK Investigational Site
    • Bedfordshire
      • Bedford, Bedfordshire, United Kingdom, MK404AW
        • GSK Investigational Site
    • Glamorgan
      • Cardiff, Glamorgan, United Kingdom, CF5 4AE
        • GSK Investigational Site
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 2RN
        • GSK Investigational Site
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L7 8XP
        • GSK Investigational Site
    • Somerset
      • Bath, Somerset, United Kingdom, BA2 1NH
        • GSK Investigational Site
    • Sussex East
      • Brighton, Sussex East, United Kingdom, BN2 5BE
        • GSK Investigational Site
    • Alabama
      • Athens, Alabama, United States, 35611
        • GSK Investigational Site
      • Birmingham, Alabama, United States, 35209
        • GSK Investigational Site
      • Birmingham, Alabama, United States, 35233
        • GSK Investigational Site
      • Birmingham, Alabama, United States, 35216
        • GSK Investigational Site
      • Florence, Alabama, United States, 35630
        • GSK Investigational Site
      • Mobile, Alabama, United States, 36608
        • GSK Investigational Site
      • Montgomery, Alabama, United States, 36109
        • GSK Investigational Site
      • Pell City, Alabama, United States, 35128
        • GSK Investigational Site
      • Scottsboro, Alabama, United States, 35768
        • GSK Investigational Site
      • Toney, Alabama, United States, 35773
        • GSK Investigational Site
      • Tuscaloosa, Alabama, United States, 35401
        • GSK Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • GSK Investigational Site
      • Flagstaff, Arizona, United States, 86001
        • GSK Investigational Site
      • Goodyear, Arizona, United States, 85395
        • GSK Investigational Site
      • Green Valley, Arizona, United States, 85614
        • GSK Investigational Site
      • Mesa, Arizona, United States, 85206
        • GSK Investigational Site
      • Mesa, Arizona, United States, 85203
        • GSK Investigational Site
      • Peoria, Arizona, United States, 85381
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85050
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85023
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85051
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 92120-4915
        • GSK Investigational Site
      • Scottsdale, Arizona, United States, 85255
        • GSK Investigational Site
      • Sierra Vista, Arizona, United States, 85635
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85704
        • GSK Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • GSK Investigational Site
      • Anaheim, California, United States, 92804
        • GSK Investigational Site
      • Bakersfield, California, United States, 93301
        • GSK Investigational Site
      • Dinuba, California, United States, 93618
        • GSK Investigational Site
      • Fresno, California, United States, 93720
        • GSK Investigational Site
      • Granada Hills, California, United States, 91344
        • GSK Investigational Site
      • Harbor City, California, United States, 90710
        • GSK Investigational Site
      • Huntington Beach, California, United States, 92647
        • GSK Investigational Site
      • Huntington Park, California, United States, 90255
        • GSK Investigational Site
      • Lomita, California, United States, 90717
        • GSK Investigational Site
      • Long Beach, California, United States, 90806
        • GSK Investigational Site
      • Long Beach, California, United States, 90813
        • GSK Investigational Site
      • Long Beach, California, United States, 90807
        • GSK Investigational Site
      • Los Angeles, California, United States, 90095
        • GSK Investigational Site
      • Los Angeles, California, United States, 90057
        • GSK Investigational Site
      • Napa, California, United States, 94558
        • GSK Investigational Site
      • Newport Beach, California, United States, 92663
        • GSK Investigational Site
      • Oxnard, California, United States, 93030
        • GSK Investigational Site
      • Paramount, California, United States, 90723
        • GSK Investigational Site
      • Pismo Beach, California, United States, 93449
        • GSK Investigational Site
      • Pomona, California, United States, 91767
        • GSK Investigational Site
      • Rolling Hills Estates, California, United States, 90274
        • GSK Investigational Site
      • Roseville, California, United States, 95678
        • GSK Investigational Site
      • Sacramento, California, United States, 95823
        • GSK Investigational Site
      • Sacramento, California, United States, 95841
        • GSK Investigational Site
      • San Gabriel, California, United States, 91776
        • GSK Investigational Site
      • San Jose, California, United States, 95116
        • GSK Investigational Site
      • San Marcos, California, United States, 92078-4081
        • GSK Investigational Site
      • San Marino, California, United States, 91108
        • GSK Investigational Site
      • San Ramon, California, United States, 94583
        • GSK Investigational Site
      • Santa Monica, California, United States, 90404
        • GSK Investigational Site
      • Ventura, California, United States, 93003
        • GSK Investigational Site
      • Vista, California, United States, 92083
        • GSK Investigational Site
      • West Covina, California, United States, 91790
        • GSK Investigational Site
      • West Sacramento, California, United States, 95691
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80906
        • GSK Investigational Site
      • Colorado Springs, Colorado, United States, 80922
        • GSK Investigational Site
      • Colorado Springs, Colorado, United States, 80907
        • GSK Investigational Site
      • Colorado Springs, Colorado, United States, 80909
        • GSK Investigational Site
      • Denver, Colorado, United States, 80206
        • GSK Investigational Site
      • Fort Collins, Colorado, United States, 80538
        • GSK Investigational Site
      • Golden, Colorado, United States, 80401
        • GSK Investigational Site
      • Thornton, Colorado, United States, 80233
        • GSK Investigational Site
      • Wheat Ridge, Colorado, United States, 80033
        • GSK Investigational Site
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • GSK Investigational Site
      • Milford, Connecticut, United States, 06460
        • GSK Investigational Site
      • Waterbury, Connecticut, United States, 06708
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • GSK Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • GSK Investigational Site
      • Brandon, Florida, United States, 33511
        • GSK Investigational Site
      • Clearwater, Florida, United States, 33756
        • GSK Investigational Site
      • Clearwater, Florida, United States, 33759
        • GSK Investigational Site
      • Cocoa, Florida, United States, 32927
        • GSK Investigational Site
      • Coral Gables, Florida, United States, 33134
        • GSK Investigational Site
      • Destin, Florida, United States, 32541
        • GSK Investigational Site
      • Doral, Florida, United States, 33172
        • GSK Investigational Site
      • Doral, Florida, United States, 33166
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33316
        • GSK Investigational Site
      • Hialeah, Florida, United States, 33016
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32205
        • GSK Investigational Site
      • Jupiter, Florida, United States, 33458
        • GSK Investigational Site
      • Maitland, Florida, United States, 32751
        • GSK Investigational Site
      • Melbourne, Florida, United States, 32935
        • GSK Investigational Site
      • Miami, Florida, United States, 33125
        • GSK Investigational Site
      • Miami, Florida, United States, 33156
        • GSK Investigational Site
      • Miami, Florida, United States, 33126
        • GSK Investigational Site
      • Miami, Florida, United States, 33175
        • GSK Investigational Site
      • Miami, Florida, United States, 33165
        • GSK Investigational Site
      • Miami, Florida, United States, 33155
        • GSK Investigational Site
      • Miami, Florida, United States, 33015
        • GSK Investigational Site
      • New Port Richey, Florida, United States, 34652
        • GSK Investigational Site
      • Orlando, Florida, United States, 32806
        • GSK Investigational Site
      • Orlando, Florida, United States, 32822
        • GSK Investigational Site
      • Orlando, Florida, United States, 32811
        • GSK Investigational Site
      • Pensacola, Florida, United States, 32514
        • GSK Investigational Site
      • Pinellas Park, Florida, United States, 33781
        • GSK Investigational Site
      • Saint Cloud, Florida, United States, 34769
        • GSK Investigational Site
      • Saint Petersburg, Florida, United States, 33710
        • GSK Investigational Site
      • Saint Petersburg, Florida, United States, 33707
        • GSK Investigational Site
      • Sarasota, Florida, United States, 34233
        • GSK Investigational Site
      • Tallahassee, Florida, United States, 32308
        • GSK Investigational Site
      • Tampa, Florida, United States, 33613
        • GSK Investigational Site
      • Tampa, Florida, United States, 33614
        • GSK Investigational Site
      • Tampa, Florida, United States, 33606
        • GSK Investigational Site
      • Tampa, Florida, United States, 33607
        • GSK Investigational Site
      • Trinity, Florida, United States, 34655
        • GSK Investigational Site
      • Vero Beach, Florida, United States, 32960
        • GSK Investigational Site
      • Wellington, Florida, United States, 33414
        • GSK Investigational Site
      • Zephyrhills, Florida, United States, 33540
        • GSK Investigational Site
    • Georgia
      • Austell, Georgia, United States, 30106
        • GSK Investigational Site
      • Columbus, Georgia, United States, 31904
        • GSK Investigational Site
      • Decatur, Georgia, United States, 30033
        • GSK Investigational Site
      • Gainesville, Georgia, United States, 30501
        • GSK Investigational Site
      • Lawrenceville, Georgia, United States, 30045
        • GSK Investigational Site
      • Lilburn, Georgia, United States, 30047
        • GSK Investigational Site
      • Rincon, Georgia, United States, 31326
        • GSK Investigational Site
      • Stockbridge, Georgia, United States, 30281
        • GSK Investigational Site
      • Tucker, Georgia, United States, 30084
        • GSK Investigational Site
    • Illinois
      • Champaign, Illinois, United States, 61820
        • GSK Investigational Site
      • Evergreen Park, Illinois, United States, 60805
        • GSK Investigational Site
      • Glen Ellyn, Illinois, United States, 60137
        • GSK Investigational Site
      • Glenview, Illinois, United States, 60025
        • GSK Investigational Site
      • Normal, Illinois, United States, 61761
        • GSK Investigational Site
      • Oak Lawn, Illinois, United States, 60453
        • GSK Investigational Site
      • Oak Park, Illinois, United States, 60302
        • GSK Investigational Site
      • Shiloh, Illinois, United States, 62269
        • GSK Investigational Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • GSK Investigational Site
      • Brownsburg, Indiana, United States, 46112
        • GSK Investigational Site
      • Crown Point, Indiana, United States, 46307
        • GSK Investigational Site
      • Franklin, Indiana, United States, 46131
        • GSK Investigational Site
      • Greenfield, Indiana, United States, 46140
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46256
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46208
        • GSK Investigational Site
      • Muncie, Indiana, United States, 47304-5547
        • GSK Investigational Site
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • GSK Investigational Site
      • Iowa City, Iowa, United States, 52242
        • GSK Investigational Site
      • West Des Moines, Iowa, United States, 50265
        • GSK Investigational Site
    • Kansas
      • Hutchinson, Kansas, United States, 67502
        • GSK Investigational Site
      • Overland Park, Kansas, United States, 66210
        • GSK Investigational Site
      • Overland Park, Kansas, United States, 66215
        • GSK Investigational Site
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • GSK Investigational Site
      • Lexington, Kentucky, United States, 40509
        • GSK Investigational Site
      • Lexington, Kentucky, United States, 40504
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 40207
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 40291
        • GSK Investigational Site
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • GSK Investigational Site
      • Covington, Louisiana, United States, 70433
        • GSK Investigational Site
    • Maine
      • Bangor, Maine, United States, 04401
        • GSK Investigational Site
      • Portland, Maine, United States, 4101
        • GSK Investigational Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • GSK Investigational Site
      • Baltimore, Maryland, United States, 21224
        • GSK Investigational Site
      • Columbia, Maryland, United States, 21045
        • GSK Investigational Site
      • Hollywood, Maryland, United States, 20636
        • GSK Investigational Site
      • Largo, Maryland, United States, 20774
        • GSK Investigational Site
      • Silver Spring, Maryland, United States, 20910
        • GSK Investigational Site
      • Towson, Maryland, United States, 21204
        • GSK Investigational Site
      • Wheaton, Maryland, United States, 20902
        • GSK Investigational Site
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • GSK Investigational Site
      • Hyannis, Massachusetts, United States, 02601
        • GSK Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • GSK Investigational Site
      • Buckley, Michigan, United States, 49620
        • GSK Investigational Site
      • Chelsea, Michigan, United States, 48118
        • GSK Investigational Site
      • Chesterfield, Michigan, United States, 48047
        • GSK Investigational Site
      • Detroit, Michigan, United States, 48235
        • GSK Investigational Site
      • Detroit, Michigan, United States, 48221
        • GSK Investigational Site
      • Fenton, Michigan, United States, 48430
        • GSK Investigational Site
      • Interlochen, Michigan, United States, 49643
        • GSK Investigational Site
      • Kalamazoo, Michigan, United States, 49009
        • GSK Investigational Site
      • Niles, Michigan, United States, 49120
        • GSK Investigational Site
      • Novi, Michigan, United States, 48375
        • GSK Investigational Site
      • Stevensville, Michigan, United States, 49127
        • GSK Investigational Site
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • GSK Investigational Site
      • Minneapolis, Minnesota, United States, 55440
        • GSK Investigational Site
    • Mississippi
      • Port Gibson, Mississippi, United States, 39150
        • GSK Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • GSK Investigational Site
      • Kansas City, Missouri, United States, 64138
        • GSK Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • GSK Investigational Site
      • Great Falls, Montana, United States, 59405
        • GSK Investigational Site
    • Nebraska
      • Bellevue, Nebraska, United States, 68005
        • GSK Investigational Site
      • Lincoln, Nebraska, United States, 68516
        • GSK Investigational Site
      • Lincoln, Nebraska, United States, 02865
        • GSK Investigational Site
      • Lincoln, Nebraska, United States, 68512
        • GSK Investigational Site
      • Omaha, Nebraska, United States, 68130
        • GSK Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89014
        • GSK Investigational Site
      • Las Vegas, Nevada, United States, 89106
        • GSK Investigational Site
      • Las Vegas, Nevada, United States, 89107
        • GSK Investigational Site
      • Las Vegas, Nevada, United States, 89183
        • GSK Investigational Site
    • New Jersey
      • Atco, New Jersey, United States, 08004
        • GSK Investigational Site
      • Brick, New Jersey, United States, 08724
        • GSK Investigational Site
      • Edison, New Jersey, United States, 08817
        • GSK Investigational Site
      • Edison, New Jersey, United States, 08820
        • GSK Investigational Site
      • Elizabeth, New Jersey, United States, 07202
        • GSK Investigational Site
      • Elizabeth, New Jersey, United States, 07201
        • GSK Investigational Site
      • Freehold, New Jersey, United States, 07728
        • GSK Investigational Site
      • Lumberton, New Jersey, United States, 08048
        • GSK Investigational Site
      • Marlton, New Jersey, United States, 08053
        • GSK Investigational Site
      • Ocean City, New Jersey, United States, 07712
        • GSK Investigational Site
      • Ridgewood, New Jersey, United States, 07450
        • GSK Investigational Site
      • Trenton, New Jersey, United States, 08611
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • GSK Investigational Site
    • New York
      • Bronx, New York, United States, 10457
        • GSK Investigational Site
      • Brooklyn, New York, United States, 11215
        • GSK Investigational Site
      • Corning, New York, United States, 14830
        • GSK Investigational Site
      • Endwell, New York, United States, 13760
        • GSK Investigational Site
      • New Windsor, New York, United States, 12553
        • GSK Investigational Site
      • New York, New York, United States, 10017
        • GSK Investigational Site
      • New York, New York, United States, 10022 11209
        • GSK Investigational Site
      • Newburgh, New York, United States, 12550
        • GSK Investigational Site
      • Utica, New York, United States, 13502
        • GSK Investigational Site
      • Westfield, New York, United States, 14787
        • GSK Investigational Site
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • GSK Investigational Site
      • Asheville, North Carolina, United States, 28803
        • GSK Investigational Site
      • Calabash, North Carolina, United States, 28467
        • GSK Investigational Site
      • Cary, North Carolina, United States, 27518
        • GSK Investigational Site
      • Charlotte, North Carolina, United States, 28207
        • GSK Investigational Site
      • Charlotte, North Carolina, United States, 28209
        • GSK Investigational Site
      • Clyde, North Carolina, United States, 28721
        • GSK Investigational Site
      • Lexington, North Carolina, United States, 27295
        • GSK Investigational Site
      • Morganton, North Carolina, United States, 28655
        • GSK Investigational Site
      • Shelby, North Carolina, United States, 28152
        • GSK Investigational Site
      • Tabor City, North Carolina, United States, 28463
        • GSK Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • GSK Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • GSK Investigational Site
      • Fargo, North Dakota, United States, 58104
        • GSK Investigational Site
    • Ohio
      • Centerville, Ohio, United States, 45459
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45231
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45236
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44130
        • GSK Investigational Site
      • Columbus, Ohio, United States, 43215
        • GSK Investigational Site
      • Dayton, Ohio, United States, 45406
        • GSK Investigational Site
      • Dayton, Ohio, United States, 45459
        • GSK Investigational Site
      • Groveport, Ohio, United States, 43125
        • GSK Investigational Site
      • Marion, Ohio, United States, 43302
        • GSK Investigational Site
      • Middleburg Heights, Ohio, United States, 44130
        • GSK Investigational Site
      • Shaker Heights, Ohio, United States, 44120
        • GSK Investigational Site
      • Springfield, Ohio, United States, 45504
        • GSK Investigational Site
      • Toledo, Ohio, United States, 43606
        • GSK Investigational Site
      • Toledo, Ohio, United States, 43617
        • GSK Investigational Site
      • Wheeling, Ohio, United States, 26003
        • GSK Investigational Site
      • Youngstown, Ohio, United States, 44501-1790
        • GSK Investigational Site
      • Zanesville, Ohio, United States, 43701
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • GSK Investigational Site
      • Oklahoma City, Oklahoma, United States, 73103
        • GSK Investigational Site
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • GSK Investigational Site
      • Lake Oswego, Oregon, United States, 97035
        • GSK Investigational Site
    • Pennsylvania
      • Belle Vernon, Pennsylvania, United States, 15012
        • GSK Investigational Site
      • Belle Vernon, Pennsylvania, United States, 15025
        • GSK Investigational Site
      • Bensalem, Pennsylvania, United States, 19020
        • GSK Investigational Site
      • Carnegie, Pennsylvania, United States, 15106
        • GSK Investigational Site
      • Downingtown, Pennsylvania, United States, 19335
        • GSK Investigational Site
      • Erie, Pennsylvania, United States, 16508
        • GSK Investigational Site
      • Holland, Pennsylvania, United States, 18966
        • GSK Investigational Site
      • Huntingdon Valley, Pennsylvania, United States, 19006
        • GSK Investigational Site
      • Jenkintown, Pennsylvania, United States, 19046
        • GSK Investigational Site
      • Lansdale, Pennsylvania, United States, 19446
        • GSK Investigational Site
      • Latrobe, Pennsylvania, United States, 15650
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19152
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19115
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15236
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15206
        • GSK Investigational Site
      • Scottdale, Pennsylvania, United States, 15683
        • GSK Investigational Site
      • Shippensburg, Pennsylvania, United States, 17257
        • GSK Investigational Site
      • Uniontown, Pennsylvania, United States, 15401
        • GSK Investigational Site
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • GSK Investigational Site
      • Johnston, Rhode Island, United States, 02919
        • GSK Investigational Site
      • Warwick, Rhode Island, United States, 02888-3221
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • GSK Investigational Site
      • Florence, South Carolina, United States, 29501
        • GSK Investigational Site
      • Greenville, South Carolina, United States, 29615
        • GSK Investigational Site
      • Greenville, South Carolina, United States, 29607
        • GSK Investigational Site
      • Greenwood, South Carolina, United States, 29646
        • GSK Investigational Site
      • Greer, South Carolina, United States, 29651
        • GSK Investigational Site
      • Union, South Carolina, United States, 29379
        • GSK Investigational Site
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • GSK Investigational Site
      • Rapid City, South Dakota, United States, 57702
        • GSK Investigational Site
      • Sioux Falls, South Dakota, United States, 57108
        • GSK Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • GSK Investigational Site
      • Chattanooga, Tennessee, United States, 37404
        • GSK Investigational Site
      • Chattanooga, Tennessee, United States, 37411
        • GSK Investigational Site
      • Germantown, Tennessee, United States, 38138
        • GSK Investigational Site
      • McKenzie, Tennessee, United States, 38201
        • GSK Investigational Site
      • Shelbyville, Tennessee, United States, 37160
        • GSK Investigational Site
    • Texas
      • Arlington, Texas, United States, 76018
        • GSK Investigational Site
      • Austin, Texas, United States, 78731
        • GSK Investigational Site
      • Austin, Texas, United States, 78758
        • GSK Investigational Site
      • Austin, Texas, United States, 78759-8950
        • GSK Investigational Site
      • Corsicana, Texas, United States, 75110
        • GSK Investigational Site
      • Dallas, Texas, United States, 75246
        • GSK Investigational Site
      • Dallas, Texas, United States, 75230
        • GSK Investigational Site
      • Dallas, Texas, United States, 75225
        • GSK Investigational Site
      • Dallas, Texas, United States, 75254
        • GSK Investigational Site
      • Duncanville, Texas, United States, 75116
        • GSK Investigational Site
      • Gun Barrel City, Texas, United States, 75156
        • GSK Investigational Site
      • Houston, Texas, United States, 77055
        • GSK Investigational Site
      • Houston, Texas, United States, 77034
        • GSK Investigational Site
      • Houston, Texas, United States, 77043
        • GSK Investigational Site
      • Houston, Texas, United States, 77077
        • GSK Investigational Site
      • Houston, Texas, United States, 77079
        • GSK Investigational Site
      • Irving, Texas, United States, 75061
        • GSK Investigational Site
      • Katy, Texas, United States, 77450
        • GSK Investigational Site
      • Kerrville, Texas, United States, 78028
        • GSK Investigational Site
      • Killeen, Texas, United States, 76542
        • GSK Investigational Site
      • Kingwood, Texas, United States, 77339
        • GSK Investigational Site
      • Lewisville, Texas, United States, 75067
        • GSK Investigational Site
      • Lufkin, Texas, United States, 75904
        • GSK Investigational Site
      • McKinney, Texas, United States, 75071
        • GSK Investigational Site
      • Plano, Texas, United States, 75075
        • GSK Investigational Site
      • Plano, Texas, United States, 75024
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78258
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78233
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78251
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78238
        • GSK Investigational Site
      • Sugar Land, Texas, United States, 77479
        • GSK Investigational Site
      • Tomball, Texas, United States, 77375
        • GSK Investigational Site
      • Tyler, Texas, United States, 75708
        • GSK Investigational Site
      • Waco, Texas, United States, 76712
        • GSK Investigational Site
      • Waco, Texas, United States, 76710
        • GSK Investigational Site
    • Utah
      • Bountiful, Utah, United States, 84010
        • GSK Investigational Site
      • Clinton, Utah, United States, 84015
        • GSK Investigational Site
      • Layton, Utah, United States, 84041
        • GSK Investigational Site
      • Midvale, Utah, United States, 84047
        • GSK Investigational Site
      • Murray, Utah, United States, 84107
        • GSK Investigational Site
      • West Jordan, Utah, United States, 84088
        • GSK Investigational Site
    • Vermont
      • Falls Church, Vermont, United States, 22044
        • GSK Investigational Site
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • GSK Investigational Site
      • Charlottesville, Virginia, United States, 22902
        • GSK Investigational Site
      • Hampton, Virginia, United States, 23666
        • GSK Investigational Site
      • Midlothian, Virginia, United States, 23114
        • GSK Investigational Site
      • Midlothian, Virginia, United States, 23113
        • GSK Investigational Site
      • Norfolk, Virginia, United States, 23507
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23229
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23235
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23223
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23233
        • GSK Investigational Site
      • Suffolk, Virginia, United States, 23435
        • GSK Investigational Site
      • Virginia Beach, Virginia, United States, 23454
        • GSK Investigational Site
    • Washington
      • Bellingham, Washington, United States, 98225
        • GSK Investigational Site
      • Port Orchard, Washington, United States, 98366
        • GSK Investigational Site
      • Puyallup, Washington, United States, 98371
        • GSK Investigational Site
      • Spokane, Washington, United States, 99204
        • GSK Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • GSK Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-9988
        • GSK Investigational 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 and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provided consent to participate in the study
  • Male or female, 12 years of age and older
  • Clinical diagnosis of asthma for at least 1 year prior to the randomization
  • Clinic PEF of greater than or equal to 50% of predicted normal value
  • Subject must be appropriately using one of the treatments for asthma listed in the protocol
  • Subject must be able to complete the asthma control questionnaire, daily questions about asthma, and use a DISKUS inhaler
  • Subject must have history of at least 1 asthma exacerbation including one of the following in the year prior to randomization:
  • requiring treatment with systemic corticosteroids
  • an asthma-related hospitalization

Exclusion Criteria:

  • History of life threatening asthma defined for this protocol as asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support
  • Concurrent respiratory disease other than asthma
  • Current evidence of, or ever been told by a physician that they have chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.
  • Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine
  • Presence of a bacterial or viral respiratory infection that is not resolved at randomization
  • An asthma exacerbation requiring systemic corticosteriods within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization
  • More than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
  • Subject must not meet unstable asthma severity criteria as listed in the protocol
  • Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
  • Pregnancy, breast-feeding or planned pregnancy during the study
  • A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADVAIR 100/50mcg
experimental drug
fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months
Other Names:
  • FSC 100/50
Experimental: ADVAIR 250/50mcg
experimental drug
fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months
Other Names:
  • FSC 250/50
Experimental: ADVAIR 500/50mcg
experimental drug
fluticasone propionate/salmeterol combination (500/50mcg) twice daily (AM and PM) for 6 months
Other Names:
  • FSC 500/50
Active Comparator: FLOVENT 100mcg
active comparator
fluticasone propionate (100) twice daily (AM and PM) for 6 months
Other Names:
  • FP 100
Active Comparator: FLOVENT 250mcg
active comparator
fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
Other Names:
  • FP 250
Active Comparator: FLOVENT 500mcg
active comparator
fluticasone propionate (500mcg) twice daily (AM and PM) for 6 months
Other Names:
  • FP 500

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)
Time Frame: From Day 1 up to 26 weeks
Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95.
From Day 1 up to 26 weeks
Number of Participants Experiencing at Least One Asthma Exacerbation
Time Frame: From Day 1 up to 26 weeks
An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
From Day 1 up to 26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death
Time Frame: From Day 1 up to 26 weeks
Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility.
From Day 1 up to 26 weeks
Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation
Time Frame: From Day 1 up to 26 weeks
An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
From Day 1 up to 26 weeks
Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours
Time Frame: From Day 1 up to 26 weeks
Rescue medication included albuterol/salbutamol used to treat acute asthma were reported as puffs per 24 hours over a period of 6 months.
From Day 1 up to 26 weeks

Collaborators and Investigators

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

Sponsor

Collaborators

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.

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 18, 2011

Primary Completion (Actual)

June 23, 2015

Study Completion (Actual)

June 23, 2015

Study Registration Dates

First Submitted

November 17, 2011

First Submitted That Met QC Criteria

November 17, 2011

First Posted (Estimate)

November 21, 2011

Study Record Updates

Last Update Posted (Actual)

August 6, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Study Protocol
    Information identifier: 115359
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Clinical Study Report
    Information identifier: 115359
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Dataset Specification
    Information identifier: 115359
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Annotated Case Report Form
    Information identifier: 115359
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistical Analysis Plan
    Information identifier: 115359
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Informed Consent Form
    Information identifier: 115359
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Individual Participant Data Set
    Information identifier: 115359
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

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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