Last updated: 11/04/2018 11:54:30
Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A multicentre, randomised, double-blind, parallel group, placebo-controlled study to investigate the long-term effects of salmeterol/fluticasone propionate (Seretide tm) 50/500mcg BD, salmeterol 50mcg BD and fluticasone propionate 500mcg BD, all delivered via the Diskus tm/Accuhaler tm inhaler, on mortality and morbidity of subjects with chronic obstructive pulmonary disease (COPD) over 3 years of treatment
Trial description: The purpose of this study is to see if fluticasone 500mcg/salmeterol 50mcg can improve the survival of subjects with COPD and also assess the long term safety profile of this drug.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Salmeterol 50mcg/ Fluticasone Propionate 500mcg
Enrollment:
6228
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Briggs A, Glick H, Lozano-Ortega G, et al. Is treatment with ICS and LABA cost-effective for COPD? Multinational economic analysis of the TORCH study. Eur Respir J 2009 Aug 28. [Epub ahead of print].
Calverley PM, Anderson JA, Celli B, et al; TORCH investigators. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007;356(8):775–89.
Celli BR, Thomas NE, Anderson JA, et al. Effect of pharmacotherapy on rate of decline of lung function in chronic obstructive pulmonary disease: results from the TORCH study. Am J Respir Crit Care Med 2008;178(4):332–8.
Christine R Jenkins, Paul W Jones, Peter M A Calverley, Bartolome Celli, Julie A Anderson, Gary T Ferguson, Julie C Yates, Lisa R Willits, Jörgen Vestbo. Efficacy of salmeterol/fluticasone propionate by GOLD stage of chronic obstructive pulmonary disease: analysis from the randomised, placebo-controlled TORCH study . [Respir Res]. 2009;10(59):
Crim C, Calverley PM, Anderson JA, et al. Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results. Eur Respir J 2009;34(3):641–7.
Ernst P, Suissa S. Pneumonia in elderly patients with chronic obstructive pulmonary disease. Curr Infect Dis Rep 2008;10(3):223–8.
Ferguson GT, Calverley PM, Anderson JA, et al. Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study. Chest 2009;136(6):1456–65.
Ferguson GT, Calverley PMA, Anderson JA, Jenkins CR, Jones PW, Willits LR, Yates JC, Vestbo J, Celli B. Prevalence and progression of osteoporosis in patients with COPD: results from TORCH. Chest. 2009;136:1456-65
Hanania NA. The impact of inhaled corticosteroid and long-acting beta-agonist combination therapy on outcomes in COPD. Pulm Pharmacol Ther 2008;21(3):540–50.
Houghton CM, Lawson N, Borrill ZL, et al. Comparison of the effects of salmeterol/fluticasone propionate with fluticasone propionate on airway physiology in adults with mild persistent asthma. Respiratory Research 2007; 8: 52.
Jenkins CR, Jones PW, Calverley PM, et al. Efficacy of salmeterol/fluticasone propionate by GOLD stage of chronic obstructive pulmonary disease: analysis from the randomised, placebo-controlled TORCH study. Respir Res 2009;10:59. [Epub].
Johnson M, Agusti AG, Barnes NC. Reflections on TORCH: potential mechanisms for the survival benefit of salmeterol/fluticasone propionate in COPD patients. COPD 2008;5:369–75.
Keene ON, Vestbo J, Anderson JA, et al. Methods for therapeutic trials in COPD: lessons from the TORCH trial. Eur Respir J 2009;34(5):1018–23.
M Bradley Drummond, Robert A Wise, Matthias John, Michael Zvarich, Lorcan P McGarvey. Accuracy of death certificates in chronic obstructive pulmonary disease: Analysis from the TORCH trial. [COPD]. 2010;7:179-185.
Marchand E. Effect of pharmacotherapy on rate of decline of FEV(1) in the TORCH study. Am J Respir Crit Care Med 2009;179(5):426; author reply 426–7.
McGarvey LP, John M, Anderson JA, et al. Ascertainment of cause-specific mortality in COPD -- operations of the TORCH Clinical Endpoint Committee. Thorax 2007;62(5):411–5.
Middleton PG. Management of patients with COPD: a comparison of the INSPIRE and TORCH studies. Am J Respir Crit Care Med 2008;178(1):106; author reply 106–7.
Miravitlles M, Anzueto A. Insights into interventions in managing COPD patients: lessons from the TORCH and UPLIFT studies. Int J Chron Obstruct Pulmon Dis 2009;4:185–201
Niewoehner DE. TORCH and UPLIFT: what has been learned from the COPD "mega-trials"? COPD 2009;6(1):1–3.
Peter M.A. Calverley, Julie A. Anderson, Bartolome Celli, Gary T. Ferguson, Christine Jenkins, Paul W. Jones, Courtney Crim, Lisa R. Willits, Julie C. Yates, Jørgen Vestbo. Cardiovascular events in patients with chronic obstructive pulmonary disease: TORCH study results. [Thorax]. 2010;65:719-725.
Salmeterol plus fluticasone fails to reduce mortality in patients with COPD. Formulary 2007;42:245–6.
Stockley RA. Progression of chronic obstructive pulmonary disease: impact of inflammation, comorbidities and therapeutic intervention. Curr Med Res Opin 2009;25:1235–45.
Suissa S, Ernst P, Vandemheen KL, Aaron SD. Methodological issues in therapeutic trials of COPD. Eur Respir J 2008;31(5):927–33.
Vestbo J and the TORCH Study Group. The TORCH (Towards a Revolution in COPD Health) survival study protocol. Eur Respir J 2004;24:206-210
Vestbo J, Anderson JA, Calverley PM, et al. Adherence to inhaled therapy, mortality and hospital admission in COPD. Thorax 2009;64(11):939–43.
A. Briggs, H. Glick, G. Lozano-Ortega, M. Spencer, P. Calverley, P. Jones, J. Vestbo, and On behalf of the TORCH investigators . Is treatment with ICS and LABA cost-effective for COPD? Multinational economic analysis of the TORCH study. Eur Respir J. 2010;35:532-9.
Bartolome Celli, Jörgen Vestbo, Christine R. Jenkins, Paul W. Jones, Gary T. Ferguson, Peter M.A. Calverley, Julie C. Yates, Julie A. Anderson, Lisa R. Willits, Robert A. Wise; on behalf of the investigators of the TORCH study . Gender Differences in Mortality and Clinical Expressions of Patients with COPD: The TORCH Experience. Am J Respir Crit Care Med. 2010
C. Crim, P. M. A. Calverley, J. A. Anderson, B. Celli, G. T. Ferguson, C. Jenkins, P. W. Jones, L. R. Willits, J. C. Yates, and J. Vestbo . Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results. Eur Respir J. 2009;34(3):641-647.
Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Yates JC, Vestbo J; TORCH investigators . Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N. Engl. J. Med. February 22nd 2007;356:775-789.
Celli BR, Thomas NE, Anderson JA, Ferguson GT, Jenkins C, Jones PW, Vestbo J, Knobil K, Yates JC, Calverley PM. Effect of Pharmacotherapy on Rate of Decline of Lung Function in COPD: Results from the TORCH Study. Am J Respir Crit Care Med. 2008;178:332-8.
Christine R Jenkins, Bartolome Celli, Julie A Anderson, Gary T Ferguson, Paul W Jones, Jørgen Vestbo, Julie C Yates and Peter M A Calverley.Seasonality and determinants of COPD exacerbations: Results from the TORCH study .Eur Respir J.2012;39(1):38-45
Christine R Jenkins, Bartolome Celli, Julie A Anderson, Gary T Ferguson, Paul W Jones, Jørgen Vestbo, Julie C Yates and Peter M A Calverley.Seasonality and determinants of moderate and severe COPD exacerbations in the TORCH study.Eur Respir J.2012;39(1):38-45
Christine R Jenkins, Paul W Jones, Peter M A Calverley, Bartolome Celli, Julie A Anderson, Gary T Ferguson, Julie C Yates, Lisa R Willits, Jörgen Vestbo. Efficacy of salmeterol/fluticasone propionate by GOLD stage of chronic obstructive pulmonary disease: analysis from the randomised, placebo-controlled TORCH study . Respir Res. 2009;10(59):
Ferguson GT, Calverley PMA, Anderson JA, Jenkins CR, Jones PW, Willits LR, Yates JC, Vestbo J, Celli B. Prevalence and progression of osteoporosis in patients with COPD: results from TORCH. Chest. 2009;136:1456-65.
Ferguson GT, Calverley PMA, Anderson JA, Jenkins CR, Jones PW, Willits LR, Yates JC, Vestbo J, Celli B.Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.Chest.2009;136(6):1456-65
Jørgen Vestbo, Julie A Anderson, Peter MA Calverley, Bartholome Celli, Gary T Ferguson, Christine Jenkins, Lisa R Willits, Julie C Yates, and Paul W Jones. Adherence to inhaled therapy, mortality, and hospital admission in COPD. Thorax. 2009;64:939-943.
Kiri VA, Bettoncelli G, Testi R, Viegi G. Inhaled corticosteroids (ICS) are more effective in reducing the risk of rehospitalization or death in severe COPD patients when used with long-acting beta agonists (LABA) than with short-acting beta agonists (SABA). Respir Med. 2005;99:1115–1124
Kiri VA, Pride NB, Soriano JB, Vestbo J.. Inhaled corticosteroids in COPD: results from two observational designs free of immortal-time bias. Am J Respir Crit Care Med. 2005;172:460–464.
M Bradley Drummond, Robert A Wise, Matthias John, Michael Zvarich, Lorcan P McGarvey. Accuracy of death certificates in chronic obstructive pulmonary disease: Analysis from the TORCH trial. COPD. 2010;7:179-185.
McGarvey L, John M, Anderson J, Zvarich M, Wise RA. Assessment of Cause-Specific Mortality in COPD -- Operations of the TORCH Clinical Endpoint Committee. Thorax. 2007 Feb 20
Paul W. Jones, Peter M.A. Calverley, Julie A. Anderson, Bartolome Celli, Gary T. Ferguson, Christine Jenkins, Julie C. Yates, Jørgen Vestbo, Michael D. Spencer, on behalf of the TORCH investigators. Health status in the TORCH study of COPD: treatment efficacy and other determinants of change. . Respir Res. 2011;12(1):71
Paul W. Jones, Peter M.A. Calverley, Julie A. Anderson, Bartolome Celli, Gary T. Ferguson, Christine Jenkins, Julie C. Yates, Jørgen Vestbo, Michael D. Spencer, on behalf of the TORCH investigators.Health status in chronic obstructive pulmonary disease across the world: measurements of treatment efficacy and determinants of change.Respir Res.2011;12:71
Peter M.A. Calverley, Julie A. Anderson, Bartolome Celli, Gary T. Ferguson, Christine Jenkins, Paul W. Jones, Courtney Crim, Lisa R. Willits, Julie C. Yates, Jørgen Vestbo. Cardiovascular events in patients with chronic obstructive pulmonary disease: TORCH study results. Thorax. 2010;65:719-725.
Sin DD, Wu L, Anderson JA, Anthonisen NR, Sonia Buist A, Sherwood Burge P, Calverley PM, Connett JE, Lindmark B, Pauwels RA, Postma DS, Soriano JS, Szafranski W, Vestbo J. Inhaled corticosteroids and mortality in COPD. Thorax. 2005;60:992-997.
The TORCH Study Group. The TORCH (TOwards a Revolution in COPD Health) survival study protocol. Eur Respir J. 2004;24:206-210.
Vestbo J, Calverley P, Celli B, Ferguson GT, Jenkins C, Jones PW.Bias due to withdrawal in long-term randomised trials in COPD: evidence from the TORCH study.Clin Respir J.2011;5(1):44-9
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
September 2000 to November 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40 - 80 years
Accepts healthy volunteers
No
- Patients with COPD and FEV1 <60% of predicted normal and baseline (pre-bronchodilator) FEV1/FVC ratio <70%.
- Current or ex-smokers with a smoking history of at least 10 pack-years.
- Diagnosis of other respiratory disorders (including asthma).
- Requirement for long term oxygen therapy.
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with COPD and FEV1 <60% of predicted normal and baseline (pre-bronchodilator) FEV1/FVC ratio <70%.
- Current or ex-smokers with a smoking history of at least 10 pack-years.
Exclusion criteria:
- Diagnosis of other respiratory disorders (including asthma).
- Requirement for long term oxygen therapy.
Trial location(s)
Location
GSK Investigational Site
Swansea, Massachusetts, United States, 02777
Status
Study Complete
Location
GSK Investigational Site
Vista, California, United States, 92083
Status
Study Complete
Location
GSK Investigational Site
Rio de Janeiro, Rio De Janeiro, Brazil, 20 551-030
Status
Study Complete
Location
GSK Investigational Site
Fullerton, California, United States, 92835
Status
Study Complete
Location
GSK Investigational Site
Brandon, Florida, United States, 33511
Status
Study Complete
Location
GSK Investigational Site
Morristown, Tennessee, United States, 37813
Status
Study Complete
Location
GSK Investigational Site
Milan, Tennessee, United States, 38372
Status
Study Complete
Location
GSK Investigational Site
Pensacola, Florida, United States, 32514
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Diego, California, United States, 92103
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35235
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1272
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Longwood, Florida, United States, 32779
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85008
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, New York, United States, 11217
Status
Study Complete
Location
GSK Investigational Site
Tamarac, Florida, United States, 33321
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94102
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
Status
Study Complete
Location
GSK Investigational Site
Johnson City, Tennessee, United States, 37601
Status
Study Complete
Location
GSK Investigational Site
Loveland, Colorado, United States, 80538
Status
Study Complete
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
Status
Study Complete
Location
GSK Investigational Site
Greenville, North Carolina, United States, 27834
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Schwetzingen, Baden-Wuerttemberg, Germany, 68723
Status
Study Complete
Location
GSK Investigational Site
Bellingham, Washington, United States, 98226
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92117
Status
Study Complete
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Study Complete
Location
GSK Investigational Site
South Bend, Indiana, United States, 46617
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30066
Status
Study Complete
Location
GSK Investigational Site
Bristol, Gloucestershire, United Kingdom, BS16 2EW
Status
Study Complete
Location
GSK Investigational Site
St. Charles, Missouri, United States, 63301
Status
Study Complete
Location
GSK Investigational Site
Roanoke, Virginia, United States, 24016
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53705
Status
Study Complete
Location
GSK Investigational Site
Downington, Pennsylvania, United States, 19335
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Peoria, Illinois, United States, 61602
Status
Study Complete
Location
GSK Investigational Site
Lafayette, Louisiana, United States, 70503
Status
Study Complete
Location
GSK Investigational Site
Pueblo, Colorado, United States, 81001
Status
Study Complete
Location
GSK Investigational Site
Cadillac, Michigan, United States, 49601
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10029
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78217
Status
Study Complete
Location
GSK Investigational Site
Decatur, Georgia, United States, 30033
Status
Study Complete
Location
GSK Investigational Site
Lake Oswego, Oregon, United States, 97035
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294-7340
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
Cranston, Rhode Island, United States, 02920
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 40110-160
Status
Study Complete
Location
GSK Investigational Site
Palm Springs, Florida, United States, 33461
Status
Study Complete
Location
GSK Investigational Site
Billings, Montana, United States, 59102
Status
Study Complete
Location
GSK Investigational Site
Encinitas, California, United States, 92024
Status
Terminated/Withdrawn
Location
GSK Investigational Site
North Chicago, Illinois, United States, 60064
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
Location
GSK Investigational Site
Rio de Janeiro, Rio De Janeiro, Brazil, 21941-590
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Study Complete
Location
GSK Investigational Site
Allentown, Pennsylvania, United States, 18104
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
Status
Study Complete
Location
GSK Investigational Site
High Point, North Carolina, United States, 27262
Status
Study Complete
Location
GSK Investigational Site
Blue Ridge, Georgia, United States, 30513
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 05403-900
Status
Study Complete
Location
GSK Investigational Site
La Crosse, Wisconsin, United States, 54601
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19148
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02135
Status
Study Complete
Location
GSK Investigational Site
Bay Pines, Florida, United States, 33744
Status
Study Complete
Location
GSK Investigational Site
Roswell, Georgia, United States, 30076
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30167
Status
Study Complete
Location
GSK Investigational Site
Fort Collins, Colorado, United States, 80528
Status
Study Complete
Location
GSK Investigational Site
New Brunswick, New Jersey, United States, 8901
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Augusta, Georgia, United States, 30901
Status
Study Complete
Location
GSK Investigational Site
Champaign, Illinois, United States, 61821
Status
Study Complete
Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Status
Study Complete
Location
GSK Investigational Site
Vicente López, Buenos Aires, Argentina, 1602
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97213-2281
Status
Study Complete
Location
GSK Investigational Site
Albany, New York, United States, 12208
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10011
Status
Study Complete
Location
GSK Investigational Site
Corsicana, Texas, United States, 75110
Status
Study Complete
Location
GSK Investigational Site
Hines, Illinois, United States, 60141-5099
Status
Study Complete
Location
GSK Investigational Site
Santiago De Compostela, Spain, 15706
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rancho Mirage, California, United States, 92270
Status
Study Complete
Location
GSK Investigational Site
Albany, New York, United States, 12205
Status
Study Complete
Location
GSK Investigational Site
Toorak Gardens, South Australia, Australia, 5065
Status
Study Complete
Location
GSK Investigational Site
St. Joseph, Michigan, United States, 49085
Status
Study Complete
Location
GSK Investigational Site
Livonia, Michigan, United States, 48152
Status
Study Complete
Location
GSK Investigational Site
Longmont, Colorado, United States, 80501
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chesapeake, Virginia, United States, 23320
Status
Study Complete
Location
GSK Investigational Site
Ostrava - Fifejdy, Czech Republic, 728 80
Status
Study Complete
Location
GSK Investigational Site
Hartford, Connecticut, United States, 06105
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19129
Status
Study Complete
Location
GSK Investigational Site
Santo Andre, São Paulo, Brazil, 09060-670
Status
Study Complete
Location
GSK Investigational Site
Sylmar, California, United States, 91342-1495
Status
Study Complete
Location
GSK Investigational Site
Summit, New Jersey, United States, 07091
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99202
Status
Study Complete
Location
GSK Investigational Site
Rio de Janeiro, Rio De Janeiro, Brazil, 20221-903
Status
Study Complete
Location
GSK Investigational Site
Traverse City, Michigan, United States, 49684
Status
Study Complete
Location
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M8 5RB
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157
Status
Study Complete
Location
GSK Investigational Site
Virginia Beach, Virginia, United States, 23454
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500691
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40536
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78205
Status
Study Complete
Location
GSK Investigational Site
Berkeley, California, United States, 94705
Status
Study Complete
Location
GSK Investigational Site
Gilford, New Hampshire, United States, 3249
Status
Study Complete
Location
GSK Investigational Site
Saint John, New Brunswick, Canada, E2M 3W5
Status
Study Complete
Location
GSK Investigational Site
N. Efkarpia, Thessaloniki, Greece, 564 29
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27514
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Altamonte Springs, Florida, United States, 32701
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85006
Status
Study Complete
Location
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45219
Status
Study Complete
Location
GSK Investigational Site
Loxahatchee, Florida, United States, 33470
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10025
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sesto San Giovanni (MI), Lombardia, Italy, 20099
Status
Study Complete
Location
GSK Investigational Site
Bielefeld, Nordrhein-Westfalen, Germany, 33602
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90822
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23225
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29403
Status
Study Complete
Location
GSK Investigational Site
East Providence, Rhode Island, United States, 02914
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55417
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97213
Status
Study Complete
Location
GSK Investigational Site
Headington, Oxfordshire, United Kingdom, OX3 7LJ
Status
Study Complete
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 05
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294
Status
Study Complete
Location
GSK Investigational Site
Ridley Park, Pennsylvania, United States, 19078
Status
Study Complete
Location
GSK Investigational Site
Fredericksburg, Virginia, United States, 22401
Status
Study Complete
Location
GSK Investigational Site
Stockton, California, United States, 95207
Status
Study Complete
Location
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80218
Status
Study Complete
Location
GSK Investigational Site
Durban, KwaZulu- Natal, South Africa, 4126
Status
Study Complete
Location
GSK Investigational Site
Sepuldeva, California, United States, 91343
Status
Study Complete
Location
GSK Investigational Site
Omaha, Nebraska, United States, 68198-2456
Status
Study Complete
Location
GSK Investigational Site
La Plata, Buenos Aires, Argentina, 1900
Status
Study Complete
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71103
Status
Study Complete
Location
GSK Investigational Site
Newcastle Upon Tyne, Northumberland, United Kingdom, NE1 4LP
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32205
Status
Study Complete
Location
GSK Investigational Site
Great Neck, New York, United States, 11023
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84102
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45267-0405
Status
Study Complete
Location
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Mineola, New York, United States, 11501
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Coeur D'Alene, Idaho, United States, 83814
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93710
Status
Study Complete
Location
GSK Investigational Site
San Luis Obispo, California, United States, 93401
Status
Study Complete
Location
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
Jefferson City, Missouri, United States, 65109
Status
Study Complete
Location
GSK Investigational Site
Exeter, Devon, United Kingdom, EX2 5DW
Status
Study Complete
Location
GSK Investigational Site
Burbank, California, United States, 91505
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Study Complete
Location
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Status
Study Complete
Location
GSK Investigational Site
Chesterfield, Missouri, United States, 63017
Status
Study Complete
Location
GSK Investigational Site
East Orange, New Jersey, United States, 07018
Status
Study Complete
Location
GSK Investigational Site
North Gosford, New South Wales, Australia, 2250
Status
Study Complete
Location
GSK Investigational Site
Arvada, Colorado, United States, 80002
Status
Study Complete
Location
GSK Investigational Site
Bronxville, New York, United States, 10708
Status
Study Complete
Location
GSK Investigational Site
Atlantis, Florida, United States, 33462
Status
Study Complete
Location
GSK Investigational Site
Trenton, New Jersey, United States, 8629
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16508
Status
Study Complete
Location
GSK Investigational Site
Bankstown, New South Wales, Australia, 22000
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
Status
Study Complete
Location
GSK Investigational Site
Liverpool, Lancashire, United Kingdom, L9 7AL
Status
Study Complete
Location
GSK Investigational Site
Edina, Minnesota, United States, 55438
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90033
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charleston, West Virginia, United States, 25304
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23249
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33756
Status
Study Complete
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39202
Status
Study Complete
Location
GSK Investigational Site
Elizabeth City, North Carolina, United States, 27909
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64108
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80206
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21204
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612-3824
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94598
Status
Study Complete
Location
GSK Investigational Site
Newark, New Jersey, United States, 07112
Status
Study Complete
Location
GSK Investigational Site
Huntington, West Virginia, United States, 25701-1693
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stamford, Connecticut, United States, 06902
Status
Study Complete
Location
GSK Investigational Site
Doylestown, Pennsylvania, United States, 8901
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40215
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035 003
Status
Study Complete
Location
GSK Investigational Site
Valparaiso, Valparaíso, Chile, 2341131
Status
Study Complete
Location
GSK Investigational Site
Maple Ridge, British Columbia, Canada, V2X 2L5
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
Sunnyvale, California, United States, 94086
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21224
Status
Study Complete
Location
GSK Investigational Site
Sarasota, Florida, United States, 34239
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15218
Status
Study Complete
Location
GSK Investigational Site
Zephyrhills, Florida, United States, 33540
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92103-6204
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14221
Status
Study Complete
Study documents
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
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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
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Additional information
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