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
Study complete
Study complete
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:
Enrollment:
6228
Primary completion date:
Not applicable
Observational study model:
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
- Inclusion criteria:
- Patients with COPD and FEV1 <60% of predicted normal and baseline (pre-bronchodilator) FEV1/FVC ratio <70%.
Inclusion and exclusion criteria
Inclusion 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
Showing 1 - 6 of 451 Results
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
Study complete
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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