6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old (VESTRI)

August 2, 2018 updated by: GlaxoSmithKline

A 6-month Safety and Benefit Study of Inhaled Fluticasone Propionate/ Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of 6,200 Pediatric Subjects 4-11 Years Old With Persistent 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 children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.

Study Overview

Status

Completed

Conditions

Asthma

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

6250

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

Argentina
- - Buenos Aires, Argentina, 1425
    - GSK Investigational Site
  - Buenos Aires, Argentina, C1425BEN
    - GSK Investigational Site
  - Buenos Aires, Argentina, 7000
    - GSK Investigational Site
  - Capital Federal, Argentina, C1270AAN
    - GSK Investigational Site
  - Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
    - GSK Investigational Site
  - Ciudad Autónoma de Buenos Aires, Argentina, 1425
    - GSK Investigational Site
  - Lanús, Argentina, B1824KAJ
    - GSK Investigational Site
  - San Miguel de Tucuman, Argentina, T4000IFL
    - GSK Investigational Site
- Buenos Aires
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1122AAK
    - GSK Investigational Site
  - Mar del Plata, Buenos Aires, Argentina, 7600
    - GSK Investigational Site
  - Nueve de Julio, Buenos Aires, Argentina, B6500BWQ
    - GSK Investigational Site
- Entre Ríos
  - Concepcion del Uruguay, Entre Ríos, Argentina, 3260
    - GSK Investigational Site
  - Parana, Entre Ríos, Argentina, E3100BHK
    - GSK Investigational Site
Australia
- - Parkville, Australia, 3052
    - GSK Investigational Site
  - Randwick, Australia, 2031
    - GSK Investigational Site
- New South Wales
  - Westmead, New South Wales, Australia, 2145
    - GSK Investigational Site
- Queensland
  - Auchenflower, Queensland, Australia, 4066
    - GSK Investigational Site
- Western Australia
  - Subiaco, Western Australia, Australia, 6008
    - GSK Investigational Site
Austria
- - Bregenz, Austria, A-6900
    - GSK Investigational Site
  - Feldkirch, Austria, 6800
    - GSK Investigational Site
  - Wien, Austria, 1090
    - GSK Investigational Site
Belgium
- - Antwerpen, Belgium, 2018
    - GSK Investigational Site
  - Brussels, Belgium, 1090
    - GSK Investigational Site
  - Gembloux, Belgium, 5030
    - GSK Investigational Site
  - Hamois (Natoye), Belgium, 5360
    - GSK Investigational Site
  - Leuven, Belgium, 3000
    - GSK Investigational Site
Bulgaria
- - Blagoevgrad, Bulgaria, 2700
    - GSK Investigational Site
  - Pleven, Bulgaria, 5800
    - GSK Investigational Site
  - Plovdiv, Bulgaria, 4002
    - GSK Investigational Site
  - Ruse, Bulgaria, 7002
    - GSK Investigational Site
  - Ruse, Bulgaria, 7000
    - GSK Investigational Site
  - Sevlievo, Bulgaria, 5400
    - GSK Investigational Site
  - Sofia, Bulgaria, 1431
    - GSK Investigational Site
  - Stara Zagora, Bulgaria, 6000
    - GSK Investigational Site
  - Varna, Bulgaria, 9010
    - GSK Investigational Site
  - Varna, Bulgaria, 9000
    - GSK Investigational Site
  - Veliko Tarnovo, Bulgaria, 5000
    - GSK Investigational Site
  - Vidin, Bulgaria, 3700
    - GSK Investigational Site
Canada
- Ontario
  - Brampton, Ontario, Canada, L6T3J1
    - GSK Investigational Site
  - Burlington, Ontario, Canada, L7L 0B7
    - 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
Chile
- - Santiago, Chile, 7560994
    - GSK Investigational Site
  - Valdivia, Chile, 5090146
    - GSK Investigational Site
  - Viña del Mar, Chile, 2570017
    - GSK Investigational Site
Colombia
- - Medellin, Colombia
    - GSK Investigational Site
Croatia
- - Cakovec, Croatia, 40000
    - GSK Investigational Site
  - Dubrovnik, Croatia, 20000
    - GSK Investigational Site
  - Jastrebarsko, Croatia, 10450
    - GSK Investigational Site
  - Rijeka, Croatia, 51000
    - GSK Investigational Site
  - Split, Croatia, 21000
    - GSK Investigational Site
  - Zagreb, Croatia, 10000
    - GSK Investigational Site
Czechia
- - Brno, Czechia, 625 00
    - GSK Investigational Site
  - Brno, Czechia, 615 00
    - GSK Investigational Site
  - Ceska Lipa, Czechia, 470 01
    - GSK Investigational Site
  - Olomouc, Czechia, 775 20
    - GSK Investigational Site
  - Praha 4, Czechia, 147 00
    - GSK Investigational Site
Germany
- - Berlin, Germany, 13353
    - GSK Investigational Site
  - Berlin, Germany, 12157
    - GSK Investigational Site
- Baden-Wuerttemberg
  - Bruchsal, Baden-Wuerttemberg, Germany, 76646
    - GSK Investigational Site
  - Mannheim, Baden-Wuerttemberg, Germany, 68167
    - GSK Investigational Site
- Bayern
  - Augsburg, Bayern, Germany, 86150
    - GSK Investigational Site
  - Fuerth, Bayern, Germany, 90762
    - GSK Investigational Site
  - Hoechstadt, Bayern, Germany, 91315
    - GSK Investigational Site
  - Weissenhorn, Bayern, Germany, 89264
    - GSK Investigational Site
- Hessen
  - Frankfurt, Hessen, Germany, 60590
    - GSK Investigational Site
- Niedersachsen
  - Bad Pyrmont, Niedersachsen, Germany, 31812
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Bad Lippspringe, Nordrhein-Westfalen, Germany, 33175
    - GSK Investigational Site
  - Bochum, Nordrhein-Westfalen, Germany, 44791
    - GSK Investigational Site
  - Detmold, Nordrhein-Westfalen, Germany, 32756
    - GSK Investigational Site
  - Hagen, Nordrhein-Westfalen, Germany, 58089
    - GSK Investigational Site
  - Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
    - GSK Investigational Site
  - Neuss, Nordrhein-Westfalen, Germany, 41469
    - GSK Investigational Site
  - Telgte, Nordrhein-Westfalen, Germany, 48291
    - GSK Investigational Site
- Sachsen-Anhalt
  - Teuchern, Sachsen-Anhalt, Germany, 6682
    - GSK Investigational Site
- Schleswig-Holstein
  - Geesthacht, Schleswig-Holstein, Germany, 21502
    - GSK Investigational Site
  - Reinfeld, Schleswig-Holstein, Germany, 23858
    - GSK Investigational Site
Hungary
- - Baja, Hungary, 6500
    - GSK Investigational Site
  - Budapest, Hungary, 1089
    - GSK Investigational Site
  - Budapest, Hungary, 1037
    - GSK Investigational Site
  - Budapest, Hungary, 1146
    - GSK Investigational Site
  - Miskolc, Hungary, 3501
    - GSK Investigational Site
  - Nagykanizsa, Hungary, 08800
    - GSK Investigational Site
  - Rackeve, Hungary, 2300
    - GSK Investigational Site
  - Szekszárd, Hungary, 7100
    - GSK Investigational Site
  - Törökbálint, Hungary, 2045
    - GSK Investigational Site
Italy
- - Brescia, Italy, 25123
    - GSK Investigational Site
  - Messina, Italy, 98123
    - GSK Investigational Site
  - Milano, Italy, 20142
    - GSK Investigational Site
  - Palermo, Italy, 90146
    - GSK Investigational Site
  - Roma, Italy, 00168
    - GSK Investigational Site
  - Sesto San Giovanni, Italy, 20099
    - GSK Investigational Site
- Lazio
  - Roma, Lazio, Italy, 00157
    - GSK Investigational Site
- Lombardia
  - Milano, Lombardia, Italy, 20129
    - GSK Investigational Site
Korea, Republic of
- - Cheongju-si, Korea, Republic of, 361-711
    - GSK Investigational Site
  - Gyeonggi-do, Korea, Republic of, 463-712
    - GSK Investigational Site
  - Gyeonggi-do, Korea, Republic of, 471-020
    - GSK Investigational Site
  - Gyeonggi-do, Korea, Republic of, 480-717
    - GSK Investigational Site
  - Incheon, Korea, Republic of, 400-711
    - GSK Investigational Site
  - Pusan, Korea, Republic of, 612030
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 120-752
    - 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, 143-729
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 130-702
    - GSK Investigational Site
Latvia
- - Riga, Latvia, LV 1003
    - GSK Investigational Site
  - Riga, Latvia, LV 1004
    - GSK Investigational Site
  - Riga, Latvia, 1011
    - GSK Investigational Site
  - Riga, Latvia, 1063
    - GSK Investigational Site
  - Tukums, Latvia, 3101
    - GSK Investigational Site
Lithuania
- - Kaunas, Lithuania, LT-50009
    - GSK Investigational Site
  - Kaunas, Lithuania, LT-49449
    - GSK Investigational Site
  - Utena, Lithuania, LT-28151
    - GSK Investigational Site
  - Vilnius, Lithuania, LT-04338
    - GSK Investigational Site
  - Vilnius, Lithuania, LT-08406
    - GSK Investigational Site
Malaysia
- - Ipoh, Malaysia, 32040
    - GSK Investigational Site
  - Kuala Lumpur, Malaysia, 59100
    - GSK Investigational Site
  - Kuching, Malaysia, 93586
    - GSK Investigational Site
  - Seremban, Negeri Sembilan, Malaysia, 70300
    - GSK Investigational Site
  - Sibu, Malaysia, 96000
    - GSK Investigational Site
  - Sungai Buloh, Malaysia, 47000
    - GSK Investigational Site
Mexico
- - Chihuahua, Mexico, 31020
    - GSK Investigational Site
  - Huixquilucan, Mexico, 52763
    - GSK Investigational Site
  - Monterrey, Mexico, 64718
    - GSK Investigational Site
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44100
    - GSK Investigational Site
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64710
    - GSK Investigational Site
Peru
- - Lima, Peru, Lima 1
    - GSK Investigational Site
  - Lima, Peru, Lima 27
    - GSK Investigational Site
  - Lima, Peru, Lima 18
    - GSK Investigational Site
  - San Borja, Peru, L36
    - GSK Investigational Site
- Lima
  - Miraflores, Lima, Peru, 18
    - GSK Investigational Site
  - San Martin de Porres, Lima, Peru, Lima 31
    - GSK Investigational Site
  - Santiago de Surco, Lima, Peru, Lima 33
    - GSK Investigational Site
Philippines
- - Dasmariñas, Cavite, Philippines, 4114
    - GSK Investigational Site
  - Davao, Philippines, 8000
    - GSK Investigational Site
  - Pulilan, Philippines, 3005
    - GSK Investigational Site
  - Quezon City, Philippines, 1100
    - GSK Investigational Site
  - Quezon City, Philippines, 1108
    - GSK Investigational Site
Poland
- - Bialystok, Poland, 15-430
    - GSK Investigational Site
  - Bialystok, Poland
    - GSK Investigational Site
  - Cieszyn, Poland, 43-400
    - GSK Investigational Site
  - Dębica, Poland, 39 - 200
    - GSK Investigational Site
  - Gdansk, Poland, 80-462
    - GSK Investigational Site
  - Gdansk, Poland, 80-308
    - GSK Investigational Site
  - Gdanska, Poland, 80-433
    - GSK Investigational Site
  - Jelenia Gora, Poland, 58-500
    - GSK Investigational Site
  - Karpacz, Poland, 58-540
    - GSK Investigational Site
  - Koszalin, Poland, 75-729
    - GSK Investigational Site
  - Krakow, Poland, 31-023
    - GSK Investigational Site
  - Krakow, Poland, 31-503
    - GSK Investigational Site
  - Lodz, Poland, 93-513
    - GSK Investigational Site
  - Lodz, Poland, 90-553
    - GSK Investigational Site
  - Lubin, Poland, 59-300
    - GSK Investigational Site
  - Lublin, Poland, 20-093
    - GSK Investigational Site
  - Lublin, Poland, 20-552
    - GSK Investigational Site
  - Poznan, Poland, 60-214
    - GSK Investigational Site
  - Rzeszow, Poland, 35-241
    - GSK Investigational Site
  - Sandomierz, Poland, 27-600
    - GSK Investigational Site
  - Skarżysko-Kamienna, Poland, 26-110
    - GSK Investigational Site
  - Skierniewice, Poland, 96-100
    - GSK Investigational Site
  - Szczecin, Poland, 70-780
    - GSK Investigational Site
  - Szczecin, Poland, 70-382
    - GSK Investigational Site
  - Tarnow, Poland, 33-100
    - GSK Investigational Site
  - Warszawa, Poland, 01-157
    - GSK Investigational Site
  - Wroclaw, Poland, 53-301
    - GSK Investigational Site
  - Wroclaw, Poland, 50-445
    - GSK Investigational Site
  - Zabrze, Poland, 41-800
    - GSK Investigational Site
  - Zabrze, Poland, 41 - 800
    - GSK Investigational Site
Romania
- - Bucharest, Romania, 20395
    - GSK Investigational Site
  - Sibiu, Romania, 550166
    - GSK Investigational Site
Russian Federation
- - Moscow, Russian Federation, 119991
    - GSK Investigational Site
  - Moscow, Russian Federation, 125412
    - GSK Investigational Site
  - Moscow, Russian Federation, 119435
    - GSK Investigational Site
  - Nizhniy Novgorod, Russian Federation, 603005
    - GSK Investigational Site
  - Novosibirsk, Russian Federation, 630099
    - GSK Investigational Site
  - Saint Petersburg, Russian Federation, 192212
    - GSK Investigational Site
  - Saint Petersburg, Russian Federation, 196657
    - GSK Investigational Site
  - Saint Petersburg, Russian Federation, 196084
    - GSK Investigational Site
  - Saratov, Russian Federation, 410028
    - GSK Investigational Site
  - St'Petersburg, Russian Federation, 191144
    - GSK Investigational Site
  - St. Petersburg, Russian Federation, 194100
    - GSK Investigational Site
  - St.Petersburg, Russian Federation, 194100
    - GSK Investigational Site
  - Tomsk, Russian Federation, 634 050
    - GSK Investigational Site
  - Voronezh, Russian Federation, 394036
    - GSK Investigational Site
  - Yaroslavl, Russian Federation, 150003
    - GSK Investigational Site
Serbia
- - Belgrade, Serbia, 11000
    - GSK Investigational Site
  - Cacak, Serbia, 32000
    - GSK Investigational Site
  - Nis, Serbia, 18000
    - GSK Investigational Site
  - Novi Sad, Serbia, 21 000
    - GSK Investigational Site
  - Uzice, Serbia, 31000
    - GSK Investigational Site
Slovakia
- - Martin, Slovakia, 036 59
    - GSK Investigational Site
  - Nitra, Slovakia, 949 01
    - GSK Investigational Site
  - Trnava, Slovakia, 917 01
    - GSK Investigational Site
South Africa
- - 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, 7572
    - GSK Investigational Site
  - Cape Town, South Africa, 7441
    - GSK Investigational Site
  - Claremont, South Africa, 7708
    - GSK Investigational Site
  - Durban, South Africa, 4001
    - GSK Investigational Site
  - Middelburg, South Africa, 1501
    - GSK Investigational Site
  - Paarl, South Africa, 7646
    - GSK Investigational Site
  - Pretoria, South Africa, 0002
    - GSK Investigational Site
  - Pretoria, South Africa, 0001
    - GSK Investigational Site
  - Thabazimbi, South Africa, 0380
    - GSK Investigational Site
- Free State
  - Welkom, Free State, South Africa, 9460
    - GSK Investigational Site
- Gauteng
  - Benoni, Gauteng, South Africa, 1501
    - GSK Investigational Site
  - Krugersdorp, Gauteng, South Africa, 1752
    - GSK Investigational Site
  - Pretoria, Gauteng, South Africa, 0132
    - GSK Investigational Site
Spain
- - Barcelona, Spain, 08022
    - GSK Investigational Site
  - Burgos, Spain, 09005
    - GSK Investigational Site
  - Madrid, Spain, 28041
    - GSK Investigational Site
  - Pozuelo De Alarcón/Madrid, Spain, 28223
    - GSK Investigational Site
  - Sabadell (Barcelona), Spain, 8208
    - GSK Investigational Site
  - Valencia, Spain, 46026
    - GSK Investigational Site
Taiwan
- - Changhua, Taiwan, 500
    - GSK Investigational Site
  - Kaohsiung, Taiwan, 813
    - GSK Investigational Site
  - Kaohsiung, Taiwan, 807
    - GSK Investigational Site
  - Taichung, Taiwan, 40447
    - GSK Investigational Site
  - Taichung, Taiwan, 402
    - GSK Investigational Site
  - Taipei, Taiwan, 100
    - GSK Investigational Site
  - Taipei, Taiwan, 11031
    - GSK Investigational Site
  - Taoyuan, Taiwan, 333
    - GSK Investigational Site
Thailand
- - Bangkok, Thailand, 10330
    - GSK Investigational Site
  - Bangkok, Thailand
    - GSK Investigational Site
  - Bangkoknoi, Thailand, 10700
    - GSK Investigational Site
  - Khon Kaen, Thailand, 40002
    - GSK Investigational Site
  - Pathumthani, Thailand, 12120
    - GSK Investigational Site
  - Phitsanulok, Thailand, 65000
    - GSK Investigational Site
  - Ratchatewi, Thailand, 10400
    - GSK Investigational Site
Ukraine
- - Dnipropetrovsk, Ukraine, 49100
    - GSK Investigational Site
  - Dnipropetrovsk, Ukraine, 49101
    - GSK Investigational Site
  - Kharkiv, Ukraine, 61093
    - GSK Investigational Site
  - Kharkiv, Ukraine, 61050
    - GSK Investigational Site
  - Kryvyi Rih, Ukraine, 50082
    - GSK Investigational Site
  - Kyiv, Ukraine
    - GSK Investigational Site
  - Kyiv, Ukraine, 4050
    - GSK Investigational Site
  - Lviv, Ukraine, 79059
    - GSK Investigational Site
  - Odesa, Ukraine, 65031
    - GSK Investigational Site
  - Odesa, Ukraine, 65038
    - GSK Investigational Site
  - Poltava, Ukraine, 36011
    - GSK Investigational Site
  - Simferopol, Ukraine, 95006
    - GSK Investigational Site
  - Sumy, Ukraine, 40031
    - GSK Investigational Site
  - Uzhhorod, Ukraine, 88009
    - GSK Investigational Site
  - Zaporizhia, Ukraine, 69063
    - GSK Investigational Site
United Kingdom
- - Barry, United Kingdom, CF63 4AR
    - GSK Investigational Site
  - Bexhill-on-Sea, United Kingdom, TN40 1JJ
    - GSK Investigational Site
  - Doncaster, United Kingdom, DN9 2HY
    - GSK Investigational Site
  - Glasgow, United Kingdom, G3 8SJ
    - GSK Investigational Site
  - Kent, United Kingdom, CT5 3QU
    - GSK Investigational Site
  - Leicester, United Kingdom, LE1 5WW
    - GSK Investigational Site
  - Macclesfield, United Kingdom, SK10 3BL
    - GSK Investigational Site
  - Merseyside, United Kingdom, CH41 0DD
    - GSK Investigational Site
  - Penzance, United Kingdom, TK19 7HX
    - GSK Investigational Site
  - Peterborough, United Kingdom, PE8 6PL
    - GSK Investigational Site
  - Stockton on Tees, United Kingdom, TS19 8PE
    - GSK Investigational Site
  - Stoke on Trent, United Kingdom, ST4 6QG
    - GSK Investigational Site
  - Surrey, United Kingdom, RH1 5RH
    - GSK Investigational Site
- Derbyshire
  - Chesterfield, Derbyshire, United Kingdom, S40 4TF
    - GSK Investigational Site
- Glamorgan
  - Cardiff, Glamorgan, United Kingdom, CF5 4AE
    - GSK Investigational Site
- Northumberland
  - Newcastle Upon Tyne, Northumberland, United Kingdom, NE1 4LP
    - 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
- Warwickshire
  - Atherstone, Warwickshire, United Kingdom, CV9 1EU
    - GSK Investigational Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35209
    - GSK Investigational Site
  - Birmingham, Alabama, United States, 35233
    - GSK Investigational Site
  - Mobile, Alabama, United States, 36608
    - GSK Investigational Site
  - Montgomery, Alabama, United States, 36109
    - 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
- Alaska
  - Dothan, Alaska, United States, 36305
    - GSK Investigational Site
- Arizona
  - Chandler, Arizona, United States, 85224
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85020
    - GSK Investigational Site
  - Scottsdale, Arizona, United States, 85288
    - GSK Investigational Site
  - Scottsdale, Arizona, United States, 85255
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85741
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85724-5073
    - GSK Investigational Site
- Arkansas
  - Bentonville, Arkansas, United States, 72712
    - GSK Investigational Site
  - Little Rock, Arkansas, United States, 72205
    - GSK Investigational Site
  - Little Rock, Arkansas, United States, 72204
    - GSK Investigational Site
  - Little Rock, Arkansas, United States, 72209
    - GSK Investigational Site
- California
  - Alhambra, California, United States, 91801
    - GSK Investigational Site
  - Bakersfield, California, United States, 93301
    - GSK Investigational Site
  - Canoga Park, California, United States, 91306
    - GSK Investigational Site
  - Dinuba, California, United States, 93618
    - GSK Investigational Site
  - Fresno, California, United States, 93720
    - GSK Investigational Site
  - Fresno, California, United States, 93703
    - GSK Investigational Site
  - Gold River, California, United States, 95670
    - 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
  - Long Beach, California, United States, 90808
    - 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, 90057
    - GSK Investigational Site
  - Napa, California, United States, 94558
    - GSK Investigational Site
  - Newport Beach, California, United States, 92663
    - GSK Investigational Site
  - Newport Beach, California, United States, 92660
    - GSK Investigational Site
  - Oakland, California, United States, 94609
    - GSK Investigational Site
  - Orange, California, United States, 92868
    - GSK Investigational Site
  - Palmdale, California, United States, 93551
    - GSK Investigational Site
  - Paramount, California, United States, 90723
    - GSK Investigational Site
  - Riverside, California, United States, 92501
    - GSK Investigational Site
  - Rolling Hills Est., California, United States, 920274
    - 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, 95825
    - GSK Investigational Site
  - San Marino, California, United States, 91108
    - GSK Investigational Site
  - Santa Monica, California, United States, 90404
    - GSK Investigational Site
  - West Covina, California, United States, 91790
    - GSK Investigational Site
  - West Sacramento, California, United States, 95691
    - GSK Investigational Site
- Colorado
  - Aurora, Colorado, United States, 80045
    - GSK Investigational Site
  - Centennial, Colorado, United States, 80112
    - 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, 80920
    - GSK Investigational Site
  - Denver, Colorado, United States, 80206
    - GSK Investigational Site
- Connecticut
  - Waterbury, Connecticut, United States, 06708
    - GSK Investigational Site
- District of Columbia
  - Washington, District of Columbia, United States, 20037
    - GSK Investigational Site
- Florida
  - Aventura, Florida, United States, 33180
    - GSK Investigational Site
  - Boynton Beach, Florida, United States, 33435
    - 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
  - Gainesville, Florida, United States, 32610
    - GSK Investigational Site
  - Gainesville, Florida, United States, 32605
    - GSK Investigational Site
  - Hialeah, Florida, United States, 33012
    - GSK Investigational Site
  - Melbourne, Florida, United States, 32935
    - GSK Investigational Site
  - Miami, Florida, United States, 33156
    - GSK Investigational Site
  - Miami, Florida, United States, 33173
    - GSK Investigational Site
  - Miami, Florida, United States, 33126
    - GSK Investigational Site
  - Miami, Florida, United States, 33135
    - GSK Investigational Site
  - Miami, Florida, United States, 33142
    - GSK Investigational Site
  - Miami, Florida, United States, 33175
    - GSK Investigational Site
  - Miami, Florida, United States, 33176
    - GSK Investigational Site
  - Miami, Florida, United States, 33144
    - GSK Investigational Site
  - Miami, Florida, United States, 33184
    - GSK Investigational Site
  - Miami Lakes, Florida, United States, 33016
    - GSK Investigational Site
  - Naples, Florida, United States, 34102
    - GSK Investigational Site
  - New Port Richey, Florida, United States, 34652
    - GSK Investigational Site
  - Ocala, Florida, United States, 34471
    - 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
  - Pace, Florida, United States, 32571
    - GSK Investigational Site
  - Pensacola, Florida, United States, 32503
    - GSK Investigational Site
  - Pensacola, Florida, United States, 32514
    - GSK Investigational Site
  - Ponte Vedra Beach, Florida, United States, 32081
    - 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, 33701
    - GSK Investigational Site
  - Tampa, Florida, United States, 33613
    - GSK Investigational Site
  - Tampa, Florida, United States, 33606
    - GSK Investigational Site
  - Wellington, Florida, United States, 33414
    - GSK Investigational Site
- Georgia
  - Augusta, Georgia, United States, 30909
    - GSK Investigational Site
  - Calhoun, Georgia, United States, 30701
    - GSK Investigational Site
  - Columbus, Georgia, United States, 31904
    - 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
  - Savannah, Georgia, United States, 31406
    - GSK Investigational Site
  - Stockbridge, Georgia, United States, 30281
    - GSK Investigational Site
- Illinois
  - Chicago, Illinois, United States, 60616
    - GSK Investigational Site
  - Evergreen Park, Illinois, United States, 60805
    - GSK Investigational Site
  - Glenview, Illinois, United States, 60025
    - GSK Investigational Site
  - Normal, Illinois, United States, 61761
    - GSK Investigational Site
  - Shiloh, Illinois, United States, 62269
    - GSK Investigational Site
- Indiana
  - Crown Point, Indiana, United States, 46307
    - GSK Investigational Site
  - Evansville, Indiana, United States, 47714
    - GSK Investigational Site
  - Evansville, Indiana, United States, 47713
    - GSK Investigational Site
  - Indianapolis, Indiana, United States, 46202
    - GSK Investigational Site
  - Indianapolis, Indiana, United States, 46256
    - GSK Investigational Site
  - Indianapolis, Indiana, United States, 46208
    - GSK Investigational Site
- Iowa
  - West Des Moines, Iowa, United States, 50265
    - GSK Investigational Site
- Kansas
  - Overland Park, Kansas, United States, 66210
    - GSK Investigational Site
- Kentucky
  - Lexington, Kentucky, United States, 40509
    - GSK Investigational Site
  - Lexington, Kentucky, United States, 40508
    - GSK Investigational Site
  - Louisville, Kentucky, United States, 40291
    - GSK Investigational Site
  - Owensboro, Kentucky, United States, 42301
    - GSK Investigational Site
- Louisiana
  - Metairie, Louisiana, United States, 70006
    - GSK Investigational Site
  - Shreveport, Louisiana, United States, 71106
    - GSK Investigational Site
- Maine
  - Bangor, Maine, United States, 04401
    - GSK Investigational Site
- Maryland
  - Largo, Maryland, United States, 20774
    - GSK Investigational Site
  - Silver Spring, Maryland, United States, 20910
    - GSK Investigational Site
  - White Marsh, Maryland, United States, 21162
    - GSK Investigational Site
- Massachusetts
  - Fall River, Massachusetts, United States, 02720
    - GSK Investigational Site
- Michigan
  - Buckley, Michigan, United States, 49620
    - GSK Investigational Site
  - Fenton, Michigan, United States, 48430
    - GSK Investigational Site
  - Niles, Michigan, United States, 49120
    - GSK Investigational Site
  - Stevensville, Michigan, United States, 49127
    - GSK Investigational Site
  - Ypsilanti, Michigan, United States, 48197
    - GSK Investigational Site
- Minnesota
  - Plymouth, Minnesota, United States, 55441
    - 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, 64108
    - GSK Investigational Site
  - Kansas City, Missouri, United States, 64138
    - GSK Investigational Site
  - Warrensburg, Missouri, United States, 64093
    - GSK Investigational Site
- Montana
  - Billings, Montana, United States, 59101
    - GSK Investigational Site
  - Great Falls, Montana, United States, 59405
    - GSK Investigational Site
  - Missoula, Montana, United States, 59808
    - GSK Investigational Site
- Nebraska
  - Bellevue, Nebraska, United States, 68123-4303
    - GSK Investigational Site
  - Bellevue, Nebraska, United States, 68005
    - GSK Investigational Site
  - Lincoln, Nebraska, United States, 68516
    - GSK Investigational Site
  - Omaha, Nebraska, United States, 68130
    - GSK Investigational Site
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - GSK Investigational Site
  - Las Vegas, Nevada, United States, 89107
    - GSK Investigational Site
- New Jersey
  - Brick, New Jersey, United States, 8724
    - GSK Investigational Site
  - Edison, New Jersey, United States, 08817
    - GSK Investigational Site
  - Edison, New Jersey, United States, 08820
    - GSK Investigational Site
  - Livingston, New Jersey, United States, 07039
    - GSK Investigational Site
  - Marlton, New Jersey, United States, 08053
    - GSK Investigational Site
  - Northfield, New Jersey, United States, 8225
    - GSK Investigational Site
  - Ocean City, New Jersey, United States, 07712
    - GSK Investigational Site
  - Somerville, New Jersey, United States, 8876
    - GSK Investigational Site
  - Verona, New Jersey, United States, 07044
    - GSK Investigational Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - GSK Investigational Site
  - Albuquerque, New Mexico, United States, 87131
    - GSK Investigational Site
- New York
  - Astoria, New York, United States, 11103
    - GSK Investigational Site
  - Bronx, New York, United States, 10461
    - GSK Investigational Site
  - Great Neck, New York, United States, 11023
    - GSK Investigational Site
  - Johnson City, New York, United States, 13790
    - GSK Investigational Site
  - Newburgh, New York, United States, 12550
    - GSK Investigational Site
  - North Syracuse, New York, United States, 13212
    - GSK Investigational Site
  - Staten Island, New York, United States, 10304
    - 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, 28801
    - GSK Investigational Site
  - Clyde, North Carolina, United States, 28721
    - GSK Investigational Site
  - High Point, North Carolina, United States, 27262
    - GSK Investigational Site
  - Shelby, North Carolina, United States, 28152
    - GSK Investigational Site
- North Dakota
  - Fargo, North Dakota, United States, 58104
    - GSK Investigational Site
- Ohio
  - Akron, Ohio, United States, 44308-1062
    - GSK Investigational Site
  - Beavercreek, Ohio, United States, 45431
    - GSK Investigational Site
  - Canton, Ohio, United States, 44718
    - GSK Investigational Site
  - Centerville, Ohio, United States, 45458
    - GSK Investigational Site
  - Cincinnati, Ohio, United States, 45231
    - GSK Investigational Site
  - Cleveland, Ohio, United States, 44130
    - GSK Investigational Site
  - Dayton, Ohio, United States, 45432
    - GSK Investigational Site
  - Dayton, Ohio, United States, 45406
    - GSK Investigational Site
  - Marion, Ohio, United States, 43302
    - GSK Investigational Site
  - Shaker Heights, Ohio, United States, 44120
    - GSK Investigational Site
  - Sylvania, Ohio, United States, 43560
    - 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
  - Zanesville, Ohio, United States, 43701
    - GSK Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73120
    - GSK Investigational Site
  - Oklahoma City, Oklahoma, United States, 73112
    - GSK Investigational Site
  - Oklahoma City, Oklahoma, United States, 73131
    - GSK Investigational Site
- Oregon
  - Ashland, Oregon, United States, 97520
    - GSK Investigational Site
  - Gresham, Oregon, United States, 97030
    - GSK Investigational Site
  - Lake Oswego, Oregon, United States, 97035
    - GSK Investigational Site
- Pennsylvania
  - Belle Vernon, Pennsylvania, United States, 15012
    - GSK Investigational Site
  - Blue Bell, Pennsylvania, United States, 19422
    - GSK Investigational Site
  - Johnstown, Pennsylvania, United States, 15904
    - GSK Investigational Site
  - Latrobe, Pennsylvania, United States, 15650
    - GSK Investigational Site
  - Pittsburgh, Pennsylvania, United States, 15212
    - GSK Investigational Site
  - Shippensburg, Pennsylvania, United States, 17257
    - GSK Investigational Site
- Rhode Island
  - Lincoln, Rhode Island, United States, 2865
    - GSK Investigational Site
- South Carolina
  - Charleston, South Carolina, United States, 29407
    - GSK Investigational Site
  - Charleston, South Carolina, United States, 29406
    - GSK Investigational Site
  - Columbia, South Carolina, United States, 29203
    - GSK Investigational Site
  - Fort Mill, South Carolina, United States, 29707
    - GSK Investigational Site
  - Greenville, South Carolina, United States, 29607
    - GSK Investigational Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37421
    - 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
  - Nashville, Tennessee, United States, 37203
    - GSK Investigational Site
  - Nashville, Tennessee, United States, 37214
    - GSK Investigational Site
  - Shelbyville, Tennessee, United States, 37160
    - GSK Investigational Site
- Texas
  - Allen, Texas, United States, 75013
    - GSK Investigational Site
  - Arlington, Texas, United States, 76018
    - 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
  - Dickinson, Texas, United States, 77539
    - GSK Investigational Site
  - Duncanville, Texas, United States, 75116
    - GSK Investigational Site
  - El Paso, Texas, United States, 79925
    - GSK Investigational Site
  - Gun Barrel City, Texas, United States, 75156
    - GSK Investigational Site
  - Houston, Texas, United States, 77036
    - GSK Investigational Site
  - Houston, Texas, United States, 77055
    - GSK Investigational Site
  - Houston, Texas, United States, 77077
    - GSK Investigational Site
  - Irving, Texas, United States, 75039
    - GSK Investigational Site
  - Katy, Texas, United States, 77450
    - 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
  - Live Oak, Texas, United States, 78233
    - GSK Investigational Site
  - Lufkin, Texas, United States, 75904
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78229
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78224
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78207
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78251
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78228
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78299
    - GSK Investigational Site
  - Sealy, Texas, United States, 77474
    - GSK Investigational Site
  - Sugar Land, Texas, United States, 77478
    - 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
  - Waxahachie, Texas, United States, 75165
    - GSK Investigational Site
- Utah
  - Clinton, Utah, United States, 84015
    - GSK Investigational Site
  - Draper, Utah, United States, 84020
    - GSK Investigational Site
  - Layton, Utah, United States, 84041
    - GSK Investigational Site
  - Murray, Utah, United States, 84107
    - GSK Investigational Site
  - Woods Cross, Utah, United States, 84087
    - GSK Investigational Site
- Virginia
  - 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, 23226
    - GSK Investigational Site
  - Richmond, Virginia, United States, 23235
    - GSK Investigational Site
  - Richmond, Virginia, United States, 23223
    - GSK Investigational Site
  - Virginia Beach, Virginia, United States, 23454
    - GSK Investigational Site
- Washington
  - Bellingham, Washington, United States, 98225
    - GSK Investigational Site
  - Puyallup, Washington, United States, 98371
    - GSK Investigational Site
  - Wenatchee, Washington, United States, 98801
    - GSK Investigational Site
- Wisconsin
  - Greenfield, Wisconsin, United States, 53228
    - GSK Investigational Site
  - La Crosse, Wisconsin, United States, 54601
    - GSK Investigational Site
  - Madison, Wisconsin, United States, 53792-9988
    - GSK Investigational Site
  - Milwaukee, Wisconsin, United States, 53226
    - 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

4 years to 11 years (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Consent to participate in the study
Age 4-11 years old
Male or eligible female - Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation
Asthma diagnosis for at least 6 months
Ability to answer questions regarding asthma control and use a metered dose inhaler and DISKUS
A history of clinical varicella infection or recipient of a varicella vaccine in countries where the product label includes a warning regarding more serious chickenpox infections in patients using corticosteroids.
History of at least once occurrence of asthma exacerbation within the prior 12 months
Currently being treated for asthma and no change in asthma therapy for the last 4 weeks (Eligible subjects include: subjects with use of short-acting beta-agonist, leukotriene receptor antagonist, theophylline, or cromolyn whose asthma is not well-controlled; subjects on low-dose ICS monotherapy whose asthma is not well-controlled; subjects on low-dose ICS and one or more adjunctive therapy whose asthma is either controlled or not well-controlled asthma; subjects on medium-dose ICS monotherapy whose asthma is either controlled or not well-controlled; and subjects on medium-dose ICS and one or more adjunctive therapy whose asthma is well-controlled)

Exclusion Criteria:

History of life-threatening asthma
Unstable asthma
Current use of high-dose ICS or ICS/LABA therapy to treat asthma symptoms
Concurrent respiratory disease: Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other severe respiratory abnormalities other than asthma.
Respiratory infection
Subjects with only exercise-induced asthma
An asthma exacerbation within the last 4 weeks or more than 4 separate exacerbations in the last 12 months
Hospitalization for asthma within 4 weeks or more than 2 hospitalizations within the last 12 months
Other current evidence of clinically significant uncontrolled disease/conditions of any body or organ system
Neurological or psychiatric disease or history of drug or alcohol abuse of a subject or his/her guardian which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirements
Participation in an interventional study or used any investigational drug for any disease state within the last 30 days
Any adverse reaction including immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy, or vehicle contained within these medication
Severe hypersensitivity to cow's milk proteins
Administration of prescription or over the counter medications that would significantly affect the course of asthma, or interact with sympathomimetic amines such as: anti-IgE (omalizumab), anticonvulsants (barbiturates, hydantoins, carbamazepine); polycyclic antidepressants, beta-adrenergic blockers; phenothiazines, monoamine oxidase inhibitors, or diuretics
Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
Affiliation with investigator's site, including a immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
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: Quadruple

Number of Arms

Arms and Interventions

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

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 6 months	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. Time to first event in the composite endpoint of serious asthma-related outcomes over the 6-month study treatment period was analyzed using a Cox proportional hazards regression model. An estimate of absolute risk difference and its corresponding 95% confidence interval (CI) were also included. The Intent-to-Treat (ITT) Population included all participants randomized to study drug and who took study treatment.	From Day 1 up to 6 months
Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period Time Frame: From Day 1 up to 6 months	Number of participants with asthma exacerbation over the 6-month study treatment period are presented. Participants from mITT population with screening childhood asthma control test (C-ACT) scores of 20 or higher, one exacerbation in the previous year, and either low-dose inhaled corticosteroid (ICS) + one or more adjunctive therapy or medium-dose ICS monotherapy or medium-dose ICS and one or more adjunctive therapy as prior asthma therapy were included for this endpoint. Time to first exacerbation analyzed using a cox proportional hazards regression model. The number of asthma exacerbations were compared between treatments using a negative binomial regression model. The modified Intent-to-Treat (mITT) Population consisted of the ITT participants with a different data cut-off for supportive analyses of the primary composite safety endpoint.	From Day 1 up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period. Time Frame: From Day 1 up to 6 months	Number of participants experiencing asthma-related death over the 6-month study treatment period are presented.	From Day 1 up to 6 months
Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period Time Frame: From Day 1 up to 6 months	Intubation is defined as endotracheal intubation with ventilation (mechanical or by hand). The number of participants experiencing asthma-related endotracheal intubations over the 6-month study treatment period are presented.	From Day 1 up to 6 months
Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period Time Frame: From Day 1 up to 6 months	Hospitalization is defined as a >=24-hour stay as an inpatient or in an observation ward. The number of participants experiencing asthma-related hospitalizations over the 6-month study treatment period are presented.	From Day 1 up to 6 months
Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period Time Frame: From Day 1 up to 6 months	An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days (up to 10 days) or a single depot corticosteroid injection. Number of participants experiencing at least one exacerbation from mITT population were included for this endpoint. The number of participants withdrawn from study treatment due to asthma exacerbation over the 6-month study treatment period are presented.	From Day 1 up to 6 months
Percentage of Rescue-free Days Over the 6-month Study Treatment Period Time Frame: From Day 1 up to 6 months	Rescue-free days were days without use of rescue albuterol/salbutamol (other than pre-exercise treatment) over the 6-month study treatment period. The mean percentages of rescue-free days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.	From Day 1 up to 6 months
Percentage of Asthma Control Days Over the 6-month Study Treatment Period Time Frame: From Day 1 up to 6 months	An asthma control day is one on which rescue albuterol/salbutamol use was recorded as 0, no night time awakenings were recorded, no asthma exacerbations were recorded, no work, school, or daycare days were missed by caregiver or participant due to asthma, coughing symptom score was <=1 and wheezing symptom score was 0. The mean percentages of asthma control days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.	From Day 1 up to 6 months

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

Collaborators

Parexel

Publications and helpful links

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

General Publications

Helpful Links

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

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

November 17, 2011

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 3, 2015

Study Registration Dates

First Submitted

October 27, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (Estimate)

October 31, 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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

115358

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

Individual Participant Data Set
Information identifier: 115358

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: 115358

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: 115358

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: 115358

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Information identifier: 115358

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: 115358

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Information identifier: 115358

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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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)

Asthma

United States, Australia, Poland, Russian Federation, Spain, Ukraine, Germany, Bulgaria, Argentina, Peru, South Africa, Taiwan, Belgium, Italy, Hungary, Korea, Republic of, Austria, Romania, Colombia, Slovakia, United Kingdom, Mexico and more
GlaxoSmithKline

Completed

GSK BHR Study (Sont - Second Study)

Asthma

United States, Bulgaria, Puerto Rico, Brazil
GlaxoSmithKline

Completed

GSK BHR Study (Sont)

Asthma

United States, Latvia, Puerto Rico, Brazil
Eurofarma Laboratorios S.A.

Withdrawn

Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis (RINEX50)

Rhinitis, Allergic, Perennial

Brazil
GlaxoSmithKline

Completed

Advair Pediatric Once-Daily

Asthma

United States, Argentina, Chile, Puerto Rico, Peru
Arthur F Gelb MD

Completed

Evaluation Inhaled Corticosteroids on Exhaled Nitric Oxide Gas Exchange

COPD

United States
GlaxoSmithKline

Completed

Dose-Ranging Study Of GSK233705B In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive

United States, Germany, Romania, Bulgaria, Argentina, Canada, Chile, Philippines, South Africa, Thailand, Netherlands, Korea, Republic of, Hungary, United Kingdom
Milton S. Hershey Medical Center
National Heart, Lung, and Blood Institute (NHLBI)

Completed

Best African American Response to Asthma Drugs (BARD)

Asthma

United States
GlaxoSmithKline

Completed

A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive

United States
GlaxoSmithKline

Completed

A Study To Assess Efficacy And Safety Of Different Doses Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive

United States, Argentina, Estonia, Canada, Chile, Germany, Peru, Philippines, Mexico, Korea, Republic of, Denmark, Russian Federation, Poland, Slovakia

6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old (VESTRI)

A 6-month Safety and Benefit Study of Inhaled Fluticasone Propionate/ Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of 6,200 Pediatric Subjects 4-11 Years Old With Persistent Asthma

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Study Data/Documents

Clinical Trials on Asthma

Clinical Trials on ADVAIR 100/50mcg

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations