Last updated: 07/17/2024 15:44:10
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
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
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)
Timeframe: From Day 1 up to 26 weeks
Number of participants experiencing at least one asthma exacerbation
Timeframe: From Day 1 up to 26 weeks
Secondary outcomes:
Number of participants experiencing at least one asthma related hospitalization , endotracheal intubation and death
Timeframe: From Day 1 up to 26 weeks
Number of participant withdrawals from study treatment due to asthma exacerbation
Timeframe: From Day 1 up to 26 weeks
Mean rescue medication (albuterol/salbutamol) use as puffs per 24 hours
Timeframe: From Day 1 up to 26 weeks
Interventions:
Enrollment:
11751
Primary completion date:
2015-23-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Stempel D, Raphiou I, Kral, K, Yeakey A, Emmett A, Prazma C, Buaron K, Pascoe S.Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone.N Engl J Med.2016;374:1822-1830.
Stanley Szefler, Ibrahim Raphiou, Robert S. Zeiger, David Stempel, Kenneth Kral, Steven Pascoe.Seasonal variation in asthma exacerbations in the AUSTRI and VESTRI studies .ERJ Open Res.2019;5:1-4
DOI: 10.1183/23120541.00153-2018
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Parexel
Study date(s)
November 2011 to June 2015
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Provided consent to participate in the study
- Male or female, 12 years of age and older
- 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
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Aguascalientes, Ags, Aguascalientes, Mexico, 20127
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92801
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92804
Status
Study Complete
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48106
Status
Study Complete
Location
GSK Investigational Site
Annapolis, Maryland, United States, 21401
Status
Study Complete
Location
GSK Investigational Site
Arlington, Texas, United States, 76018
Status
Study Complete
Location
GSK Investigational Site
Asheboro, North Carolina, United States, 27203
Status
Study Complete
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28803
Status
Study Complete
Location
GSK Investigational Site
Atco, New Jersey, United States, 08004
Status
Study Complete
Location
GSK Investigational Site
Austell, Georgia, United States, 30106
Status
Study Complete
Location
GSK Investigational Site
Austin, Texas, United States, 78759-8950
Status
Study Complete
Location
GSK Investigational Site
Bad Pyrmont, Niedersachsen, Germany, 31812
Status
Study Complete
Location
GSK Investigational Site
Bad Woerrishofen, Bayern, Germany, 86825
Status
Study Complete
Location
GSK Investigational Site
Bakerfield, California, United States, 93301
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21224
Status
Study Complete
Location
GSK Investigational Site
Bedford Park, South Australia, Australia, 5042
Status
Study Complete
Location
GSK Investigational Site
Bell Vernon, Pennsylvania, United States, 15012
Status
Study Complete
Location
GSK Investigational Site
Belle Vernon, Pennsylvania, United States, 15012
Status
Study Complete
Location
GSK Investigational Site
Bellevue, Nebraska, United States, 68005
Status
Study Complete
Location
GSK Investigational Site
Bellingham, Washington, United States, 98225
Status
Study Complete
Location
GSK Investigational Site
Bensalem, Pennsylvania, United States, 19020
Status
Study Complete
Location
GSK Investigational Site
Bergisch Gladbach, Nordrhein-Westfalen, Germany, 51429
Status
Study Complete
Location
GSK Investigational Site
Bexhill-on-Sea, United Kingdom, TN40 1JJ
Status
Study Complete
Location
GSK Investigational Site
Billings, Montana, United States, 59101
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35209
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35216
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35233
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
Status
Study Complete
Location
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53119
Status
Study Complete
Location
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53123
Status
Study Complete
Location
GSK Investigational Site
Boynton Beach, Florida, United States, 33437
Status
Study Complete
Location
GSK Investigational Site
Brandon, Florida, United States, 33511
Status
Study Complete
Location
GSK Investigational Site
Brick, New Jersey, United States, 08724
Status
Study Complete
Location
GSK Investigational Site
Brighton, Sussex East, United Kingdom, BN2 5BE
Status
Study Complete
Location
GSK Investigational Site
Bronx,, New York, United States, 10457
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, New York, United States, 11215
Status
Study Complete
Location
GSK Investigational Site
Brownsburg, Indiana, United States, 46112
Status
Study Complete
Location
GSK Investigational Site
Buckley, Michigan, United States, 49620
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1425
Status
Study Complete
Location
GSK Investigational Site
CROWN POINT, Indiana, United States, 46307
Status
Study Complete
Location
GSK Investigational Site
Calabash, North Carolina, United States, 28467
Status
Study Complete
Location
GSK Investigational Site
Canet de Mar - Barcelona, Spain, 08360
Status
Study Complete
Location
GSK Investigational Site
Cape Town, Gauteng, South Africa, 7505
Status
Study Complete
Location
GSK Investigational Site
Cardiff, Glamorgan, United Kingdom, CF5 4AE
Status
Study Complete
Location
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
Status
Study Complete
Location
GSK Investigational Site
Cary, North Carolina, United States, 27518
Status
Study Complete
Location
GSK Investigational Site
Centerville, Ohio, United States, 45459
Status
Study Complete
Location
GSK Investigational Site
Champaign, Illinois, United States, 61820
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85224
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Chaska, Minnesota, United States, 55318
Status
Study Complete
Location
GSK Investigational Site
Chattanooga, Tennessee, United States, 37404
Status
Study Complete
Location
GSK Investigational Site
Chattanooga, Tennessee, United States, 37421
Status
Study Complete
Location
GSK Investigational Site
Chelsea, Michigan, United States, 48118
Status
Study Complete
Location
GSK Investigational Site
Chertsey, Surrey, United Kingdom, KT16 0PZ
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45236
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33756
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33759
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80906
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80922
Status
Study Complete
Location
GSK Investigational Site
Columbia, Maryland, United States, 21045
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Study Complete
Location
GSK Investigational Site
Columbus, Georgia, United States, 31904
Status
Study Complete
Location
GSK Investigational Site
Concepcion del Uruguay, Entre Ríos, Argentina, 3260
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Corning, New York, United States, 14830
Status
Study Complete
Location
GSK Investigational Site
Corsicana, Texas, United States, 75110
Status
Study Complete
Location
GSK Investigational Site
Council Bluffs, Iowa, United States, 51503
Status
Study Complete
Location
GSK Investigational Site
Covington, Louisiana, United States, 70433
Status
Study Complete
Location
GSK Investigational Site
Dakota Dunes, South Dakota, United States, 57049
Status
Study Complete
Location
GSK Investigational Site
Danbury, Connecticut, United States, 06810
Status
Study Complete
Location
GSK Investigational Site
Decatur, Georgia, United States, 30033
Status
Study Complete
Location
GSK Investigational Site
Deggingen, Baden-Wuerttemberg, Germany, 73326
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80206
Status
Study Complete
Location
GSK Investigational Site
Derqui, Pilar, Buenos Aires, Argentina, B1629AHJ
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48221
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48235
Status
Study Complete
Location
GSK Investigational Site
Dinuba, California, United States, 93618
Status
Study Complete
Location
GSK Investigational Site
Downington, Pennsylvania, United States, 19335
Status
Study Complete
Location
GSK Investigational Site
Duncanville, Texas, United States, 75116
Status
Study Complete
Location
GSK Investigational Site
East Greenwich, Rhode Island, United States, 02818
Status
Study Complete
Location
GSK Investigational Site
Edison, New Jersey, United States, 08817
Status
Study Complete
Location
GSK Investigational Site
Edison, New Jersey, United States, 08820
Status
Study Complete
Location
GSK Investigational Site
Elizabeth, New Jersey, United States, 07201
Status
Study Complete
Location
GSK Investigational Site
Elizabeth, New Jersey, United States, 07202
Status
Study Complete
Location
GSK Investigational Site
Eloffsdal, Gauteng, South Africa, 0084
Status
Study Complete
Location
GSK Investigational Site
Engelskirchen, Nordrhein-Westfalen, Germany, 51766
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16508
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45136
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
Status
Study Complete
Location
GSK Investigational Site
Evergreen Park, Illinois, United States, 60805
Status
Study Complete
Location
GSK Investigational Site
Fall River, Massachusetts, United States, 02720
Status
Study Complete
Location
GSK Investigational Site
Falls Church, Vermont, United States, 22044
Status
Study Complete
Location
GSK Investigational Site
Fargo, North Dakota, United States, 58103
Status
Study Complete
Location
GSK Investigational Site
Fargo, North Dakota, United States, 58104
Status
Study Complete
Location
GSK Investigational Site
Fenton, Michigan, United States, 48430
Status
Study Complete
Location
GSK Investigational Site
Flagstaff, Arizona, United States, 86001
Status
Study Complete
Location
GSK Investigational Site
Fort Collins, Colorado, United States, 80538
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
Status
Study Complete
Location
GSK Investigational Site
Franklin, Indiana, United States, 46131
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Georgia, United States, 30501
Status
Study Complete
Location
GSK Investigational Site
Georgensgmuend, Bayern, Germany, 91166
Status
Study Complete
Location
GSK Investigational Site
Glenview, Illinois, United States, 60025
Status
Study Complete
Location
GSK Investigational Site
Golden, Colorado, United States, 80401
Status
Study Complete
Location
GSK Investigational Site
Goodyear, Arizona, United States, 85395
Status
Study Complete
Location
GSK Investigational Site
Granada Hills, California, United States, 91344
Status
Study Complete
Location
GSK Investigational Site
Great Falls, Montana, United States, 59405
Status
Study Complete
Location
GSK Investigational Site
Green Valley, Arizona, United States, 85614
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Greenwood, South Carolina, United States, 29646
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Gun Barrel City, Texas, United States, 75156
Status
Study Complete
Location
GSK Investigational Site
Hagen, Nordrhein-Westfalen, Germany, 58089
Status
Study Complete
Location
GSK Investigational Site
Hampton, Virginia, United States, 23666
Status
Study Complete
Location
GSK Investigational Site
Harbor City, California, United States, 90710
Status
Study Complete
Location
GSK Investigational Site
Havlickuv brod, Czech Republic, 580 01
Status
Study Complete
Location
GSK Investigational Site
Hazard, Kentucky, United States, 41701
Status
Study Complete
Location
GSK Investigational Site
Henderson, Nevada, United States, 89014
Status
Study Complete
Location
GSK Investigational Site
Hialeah, Florida, United States, 33016
Status
Study Complete
Location
GSK Investigational Site
Holland, Pennsylvania, United States, 18966
Status
Study Complete
Location
GSK Investigational Site
Hollywood, Maryland, United States, 20636
Status
Study Complete
Location
GSK Investigational Site
Huntingdon Valley, Pennsylvania, United States, 19006
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Hyannis, Massachusetts, United States, 02601
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46208
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46256
Status
Study Complete
Location
GSK Investigational Site
Interlochen, Michigan, United States, 49643
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32205
Status
Study Complete
Location
GSK Investigational Site
Jenkintown, Pennsylvania, United States, 19046
Status
Study Complete
Location
GSK Investigational Site
Johnston, Rhode Island, United States, 02919
Status
Study Complete
Location
GSK Investigational Site
Jupiter, Florida, United States, 33458
Status
Study Complete
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49009
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64114
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64138
Status
Study Complete
Location
GSK Investigational Site
Kerrville, Texas, United States, 78028
Status
Study Complete
Location
GSK Investigational Site
Klappholz, Schleswig-Holstein, Germany, 24860
Status
Study Complete
Location
GSK Investigational Site
Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
Status
Study Complete
Location
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56068
Status
Study Complete
Location
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47798
Status
Study Complete
Location
GSK Investigational Site
Krugersdorp, Gauteng, South Africa, 1752
Status
Study Complete
Location
GSK Investigational Site
Lake Oswego, Oregon, United States, 97035
Status
Study Complete
Location
GSK Investigational Site
Landsdale, Pennsylvania, United States, 19446
Status
Study Complete
Location
GSK Investigational Site
Lansdale, Pennsylvania, United States, 19446
Status
Study Complete
Location
GSK Investigational Site
Lanús, Buenos Aires, Argentina, B1824KAJ
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89106
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89107
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89183
Status
Study Complete
Location
GSK Investigational Site
Latrobe, Pennsylvania, United States, 15650
Status
Study Complete
Location
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
Status
Study Complete
Location
GSK Investigational Site
Lewisville, Texas, United States, 75067
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40509
Status
Study Complete
Location
GSK Investigational Site
Lexington, North Carolina, United States, 27295
Status
Study Complete
Location
GSK Investigational Site
Lilburn, Georgia, United States, 30047
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 02865
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68512
Status
Study Complete
Location
GSK Investigational Site
Liverpool, Merseyside, United Kingdom, L7 8XP
Status
Study Complete
Location
GSK Investigational Site
Lomita, California, United States, 90717
Status
Study Complete
Location
GSK Investigational Site
London, London, United Kingdom, E9 6SR
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90807
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90813
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90057
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40291
Status
Study Complete
Location
GSK Investigational Site
Lumberton, New Jersey, United States, 08048
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792-9988
Status
Study Complete
Location
GSK Investigational Site
Manchester, Greater Manchester, United Kingdom, M20 2RN
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
Status
Study Complete
Location
GSK Investigational Site
Marlton, New Jersey, United States, 08053
Status
Study Complete
Location
GSK Investigational Site
Melbourne, Florida, United States, 32935
Status
Study Complete
Location
GSK Investigational Site
Middleburg Heights, Ohio, United States, 44130
Status
Study Complete
Location
GSK Investigational Site
Midlothian, Virginia, United States, 23114
Status
Study Complete
Location
GSK Investigational Site
Milford, Connecticut, United States, 06460
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55440
Status
Study Complete
Location
GSK Investigational Site
Montgomery, Alabama, United States, 36109
Status
Study Complete
Location
GSK Investigational Site
Morganton, North Carolina, United States, 28655
Status
Study Complete
Location
GSK Investigational Site
Morgantown, West Virginia, United States, 26505
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48149
Status
Study Complete
Location
GSK Investigational Site
Muncie, Indiana, United States, 47304-5547
Status
Study Complete
Location
GSK Investigational Site
Napa, California, United States, 94558
Status
Study Complete
Location
GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41469
Status
Study Complete
Location
GSK Investigational Site
New Port Richey, Florida, United States, 34652
Status
Study Complete
Location
GSK Investigational Site
New Windsor, New York, United States, 12553
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10022 11209
Status
Study Complete
Location
GSK Investigational Site
Newport Beach, California, United States, 92663
Status
Study Complete
Location
GSK Investigational Site
Norfolk, Virginia, United States, 23507
Status
Study Complete
Location
GSK Investigational Site
Normal, Illinois, United States, 61761
Status
Study Complete
Location
GSK Investigational Site
Nueve de Julio, Buenos Aires, Argentina, B6500BWQ
Status
Study Complete
Location
GSK Investigational Site
Oak Lawn, Illinois, United States, 60453
Status
Study Complete
Location
GSK Investigational Site
Ocean, New Jersey, United States, 07712
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32806
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32811
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32822
Status
Study Complete
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66210
Status
Study Complete
Location
GSK Investigational Site
Oxnard, California, United States, 93030
Status
Study Complete
Location
GSK Investigational Site
Parana, Entre Ríos, Argentina, E3100BHK
Status
Study Complete
Location
GSK Investigational Site
Pell City, Alabama, United States, 35128
Status
Study Complete
Location
GSK Investigational Site
Pensacola, Florida, United States, 32514
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19115
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19152
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85050
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 92120-4915
Status
Study Complete
Location
GSK Investigational Site
Pinellas Park, Florida, United States, 33781
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15206
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Pomona, California, United States, 91767
Status
Study Complete
Location
GSK Investigational Site
Port Elizabeth, Eastern Cape, South Africa, 6014
Status
Study Complete
Location
GSK Investigational Site
Port Gibson, Mississippi, United States, 39150
Status
Study Complete
Location
GSK Investigational Site
Port Orchard, Washington, United States, 98366
Status
Study Complete
Location
GSK Investigational Site
Pozuelo de Alarcón/Madrid, Spain, 28223
Status
Study Complete
Location
GSK Investigational Site
Puyallup, Washington, United States, 98371
Status
Study Complete
Location
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Status
Study Complete
Location
GSK Investigational Site
Rapid City, South Dakota, United States, 57702
Status
Study Complete
Location
GSK Investigational Site
Ratingen, Nordrhein-Westfalen, Germany, 40878
Status
Study Complete
Location
GSK Investigational Site
Raubach, Rheinland-Pfalz, Germany, 56316
Status
Study Complete
Location
GSK Investigational Site
Redcliffe, Queensland, Australia, 4020
Status
Study Complete
Location
GSK Investigational Site
Reinfeld, Schleswig-Holstein, Germany, 23858
Status
Study Complete
Location
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23223
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23229
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23233
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23235
Status
Study Complete
Location
GSK Investigational Site
Ridgewood, New Jersey, United States, 07450
Status
Study Complete
Location
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000JKR
Status
Study Complete
Location
GSK Investigational Site
Roseville, California, United States, 95678
Status
Study Complete
Location
GSK Investigational Site
Saarbruecken, Saarland, Germany, 66111
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95823
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95841
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78233
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78251
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78258
Status
Study Complete
Location
GSK Investigational Site
San Gabriel, California, United States, 91776
Status
Study Complete
Location
GSK Investigational Site
San Jose, California, United States, 95116
Status
Study Complete
Location
GSK Investigational Site
San Marcos, California, United States, 92078-4081
Status
Study Complete
Location
GSK Investigational Site
San Marino, California, United States, 91108
Status
Study Complete
Location
GSK Investigational Site
San Martin, Buenos Aires, Argentina, 1650
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucuman, Tucumán, Argentina, 4000
Status
Study Complete
Location
GSK Investigational Site
San Ramon, California, United States, 94583
Status
Study Complete
Location
GSK Investigational Site
Santa Monica, California, United States, 90404
Status
Study Complete
Location
GSK Investigational Site
Scottsboro, Alabama, United States, 35768
Status
Study Complete
Location
GSK Investigational Site
Shaker Heights, Ohio, United States, 44120
Status
Study Complete
Location
GSK Investigational Site
Shelby, North Carolina, United States, 28152
Status
Study Complete
Location
GSK Investigational Site
Shelbyville, Tennessee, United States, 37160
Status
Study Complete
Location
GSK Investigational Site
Shiloh, Illinois, United States, 62269
Status
Study Complete
Location
GSK Investigational Site
Shippensburg, Pennsylvania, United States, 17257
Status
Study Complete
Location
GSK Investigational Site
Sierra Vista, Arizona, United States, 85635
Status
Study Complete
Location
GSK Investigational Site
Silver Spring, Maryland, United States, 20910
Status
Study Complete
Location
GSK Investigational Site
Sioux Falls, South Dakota, United States, 57108
Status
Study Complete
Location
GSK Investigational Site
Solingen, Nordrhein-Westfalen, Germany, 42651
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Study Complete
Location
GSK Investigational Site
Springfield, Ohio, United States, 45504
Status
Study Complete
Location
GSK Investigational Site
St Petersburg, Florida, United States, 33707
Status
Study Complete
Location
GSK Investigational Site
St. Cloud, Florida, United States, 34769
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33710
Status
Study Complete
Location
GSK Investigational Site
Stevensville, Michigan, United States, 49127
Status
Study Complete
Location
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
Status
Study Complete
Location
GSK Investigational Site
Stoke on Trent, United Kingdom, ST4 6QG
Status
Study Complete
Location
GSK Investigational Site
Suffolk, Virginia, United States, 23435
Status
Study Complete
Location
GSK Investigational Site
Surrey, British Columbia, Canada, V35 2N6
Status
Study Complete
Location
GSK Investigational Site
Tabor City, North Carolina, United States, 28463
Status
Study Complete
Location
GSK Investigational Site
Tallahassee, Florida, United States, 32308
Status
Study Complete
Location
GSK Investigational Site
Tampa/Florida, Florida, United States, 33607
Status
Study Complete
Location
GSK Investigational Site
Thornton, Colorado, United States, 80233
Status
Study Complete
Location
GSK Investigational Site
Towson, Maryland, United States, 21204
Status
Study Complete
Location
GSK Investigational Site
Trenton, New Jersey, United States, 08611
Status
Study Complete
Location
GSK Investigational Site
Trinity, Florida, United States, 34655
Status
Study Complete
Location
GSK Investigational Site
Tucscon, Arizona, United States, 85704
Status
Study Complete
Location
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35401
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Study Complete
Location
GSK Investigational Site
Uniontown, Pennsylvania, United States, 15401
Status
Study Complete
Location
GSK Investigational Site
Valparaiso, Valparaíso, Chile, 2341131
Status
Study Complete
Location
GSK Investigational Site
Ventura, California, United States, 93003
Status
Study Complete
Location
GSK Investigational Site
Vero Beach, Florida, United States, 32960
Status
Study Complete
Location
GSK Investigational Site
Virginia Beach, Virginia, United States, 23454
Status
Study Complete
Location
GSK Investigational Site
Vista, California, United States, 92083
Status
Study Complete
Location
GSK Investigational Site
Warwick, Rhode Island, United States, 02888-3221
Status
Study Complete
Location
GSK Investigational Site
Waterbury, Connecticut, United States, 06708
Status
Study Complete
Location
GSK Investigational Site
Wellington, Florida, United States, 33414
Status
Study Complete
Location
GSK Investigational Site
West Covina, California, United States, 91790
Status
Study Complete
Location
GSK Investigational Site
West Des Moines, Iowa, United States, 50265
Status
Study Complete
Location
GSK Investigational Site
West Jordan, Utah, United States, 84088
Status
Study Complete
Location
GSK Investigational Site
West Sacramento, California, United States, 95691
Status
Study Complete
Location
GSK Investigational Site
Westfield, New York, United States, 14787
Status
Study Complete
Location
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Status
Study Complete
Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Study Complete
Location
GSK Investigational Site
Wheaton, Maryland, United States, 20902
Status
Study Complete
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
Status
Study Complete
Location
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58452
Status
Study Complete
Location
GSK Investigational Site
Wolfsburg, Niedersachsen, Germany, 38448
Status
Study Complete
Location
GSK Investigational Site
Woolloongabba, Queensland, Australia, 4102
Status
Study Complete
Location
GSK Investigational Site
Youngstown, Ohio, United States, 44501-1790
Status
Study Complete
Location
GSK Investigational Site
Zanesville, Ohio, United States, 43701
Status
Study Complete
Location
GSK Investigational Site
Zephyrhills, Florida, United States, 33540
Status
Study Complete
Location
GSK Investigational Site
Zerbst, Sachsen-Anhalt, Germany, 39261
Status
Study Complete
Study documents
Protocol
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2015-23-06
Actual study completion date
2015-23-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
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