Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT00268216
Last Updated: 2017-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
6228 participants
INTERVENTIONAL
2000-09-30
2005-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Salmeterol 50mcg/ Fluticasone Propionate 500mcg
Eligibility Criteria
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Inclusion Criteria
* Current or ex-smokers with a smoking history of at least 10 pack-years.
Exclusion Criteria
* Requirement for long term oxygen therapy.
40 Years
80 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Jasper, Alabama, United States
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Mobile, Alabama, United States
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Ozark, Alabama, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Berkeley, California, United States
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Burbank, California, United States
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Encinitas, California, United States
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Fresno, California, United States
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Fullerton, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Rancho Mirage, California, United States
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Riverside, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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San Luis Obispo, California, United States
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Sepuldeva, California, United States
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Stockton, California, United States
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Sunnyvale, California, United States
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Sylmar, California, United States
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Vista, California, United States
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Walnut Creek, California, United States
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Arvada, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Fort Collins, Colorado, United States
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Longmont, Colorado, United States
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Loveland, Colorado, United States
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Pueblo, Colorado, United States
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Wheat Ridge, Colorado, United States
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Hartford, Connecticut, United States
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Stamford, Connecticut, United States
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Altamonte Springs, Florida, United States
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Atlantis, Florida, United States
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Bay Pines, Florida, United States
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Brandon, Florida, United States
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Clearwater, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Largo, Florida, United States
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Longwood, Florida, United States
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Loxahatchee Groves, Florida, United States
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Miami, Florida, United States
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Pace, Florida, United States
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Palm Springs, Florida, United States
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Pensacola, Florida, United States
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Sarasota, Florida, United States
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Tamarac, Florida, United States
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Elizabeth City, North Carolina, United States
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Bellingham, Washington, United States
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Huntington, West Virginia, United States
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La Crosse, Wisconsin, United States
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Buenos Aires, Buenos Aires, Argentina
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Camperdown, New South Wales, Australia
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North Gosford, New South Wales, Australia
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Adelaide, South Australia, Australia
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Toorak Gardens, South Australia, Australia
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Frankston, Victoria, Australia
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Geelong, Victoria, Australia
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Rio de Janeiro, Rio de Janeiro, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Pleven, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Maple Ridge, British Columbia, Canada
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Saint John, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Mississauga, Ontario, Canada
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Mississauga, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Sainte-Foy, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Temuco, Región de La Araucania, Chile
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Valparaíso, Región de Valparaíso, Chile
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Santiago, Región Metro de Santiago, Chile
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Guangzhou, Guangdong, China
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Nanjing, Jiangsu, China
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Xi'an, Shaanxi, China
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Chongqing, , China
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Wangfujing, Beijing, , China
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Zagreb, , Croatia
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Hradec Králové, , Czechia
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Jaroměř, , Czechia
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Ostrava - Fifejdy, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Tábor, , Czechia
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Aarhus C, , Denmark
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Hvidovre, , Denmark
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København NV, , Denmark
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Silkenborg, , Denmark
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Tallinn, , Estonia
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Tartu, , Estonia
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Helsinki, , Finland
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Helsinki, , Finland
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Kinkomaa, , Finland
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Lappeenranta, , Finland
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Lohja, , Finland
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Mikkeli, , Finland
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Pori, , Finland
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Vantaa, , Finland
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Annonay, , France
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Béthune, , France
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Caen, , France
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Chamalières, , France
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Férolles-Attilly, , France
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Grenoble, , France
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Tarbes, , France
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Athens, , Greece
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Heraklion, Crete, , Greece
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Heraklion, Crete, , Greece
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Kavala, , Greece
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Larissa, , Greece
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Maroussi, Athens, , Greece
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Bristol, Gloucestershire, United Kingdom
GSK Investigational Site
Liverpool, Lancashire, United Kingdom
GSK Investigational Site
Manchester, Lancashire, United Kingdom
GSK Investigational Site
Newcastle upon Tyne, Northumberland, United Kingdom
GSK Investigational Site
Headington, Oxfordshire, United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
, ,
Countries
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References
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Briggs AH, Glick HA, Lozano-Ortega G, Spencer M, Calverley PM, Jones PW, Vestbo J; TOwards a Revolution in COPD Health (TORCH) investigators. Is treatment with ICS and LABA cost-effective for COPD? Multinational economic analysis of the TORCH study. Eur Respir J. 2010 Mar;35(3):532-9. doi: 10.1183/09031936.00153108. Epub 2009 Aug 28.
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. 2007 Feb 22;356(8):775-89. doi: 10.1056/NEJMoa063070.
Celli BR, Thomas NE, Anderson JA, Ferguson GT, Jenkins CR, Jones PW, Vestbo J, Knobil K, Yates JC, Calverley PM. 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 Aug 15;178(4):332-8. doi: 10.1164/rccm.200712-1869OC. Epub 2008 May 29.
Jenkins CR, Jones PW, Calverley PM, Celli B, Anderson JA, Ferguson GT, Yates JC, Willits LR, Vestbo J. Efficacy of salmeterol/fluticasone propionate by GOLD stage of chronic obstructive pulmonary disease: analysis from the randomised, placebo-controlled TORCH study. Respir Res. 2009 Jun 30;10(1):59. doi: 10.1186/1465-9921-10-59.
Crim C, Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Willits LR, Yates JC, Vestbo J. Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results. Eur Respir J. 2009 Sep;34(3):641-7. doi: 10.1183/09031936.00193908. Epub 2009 May 14.
Ernst P, Suissa S. Pneumonia in elderly patients with chronic obstructive pulmonary disease. Curr Infect Dis Rep. 2008 May;10(3):223-8. doi: 10.1007/s11908-008-0037-4.
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 Dec;136(6):1456-1465. doi: 10.1378/chest.08-3016. Epub 2009 Jul 6.
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. doi: 10.1016/j.pupt.2007.12.004. Epub 2008 Jan 6.
Houghton CM, Lawson N, Borrill ZL, Wixon CL, Yoxall S, Langley SJ, Woodcock A, Singh D. Comparison of the effects of salmeterol/fluticasone propionate with fluticasone propionate on airway physiology in adults with mild persistent asthma. Respir Res. 2007 Jul 14;8(1):52. doi: 10.1186/1465-9921-8-52.
Johnson M, Agusti AG, Barnes NC. Reflections on TORCH: potential mechanisms for the survival benefit of salmeterol/fluticasone propionate in COPD patients. COPD. 2008 Dec;5(6):369-75. doi: 10.1080/15412550802522924.
Keene ON, Vestbo J, Anderson JA, Calverley PM, Celli B, Ferguson GT, Jenkins C, Jones PW. Methods for therapeutic trials in COPD: lessons from the TORCH trial. Eur Respir J. 2009 Nov;34(5):1018-23. doi: 10.1183/09031936.00122608.
Drummond MB, Wise RA, John M, Zvarich MT, McGarvey LP. Accuracy of death certificates in COPD: analysis from the TORCH trial. COPD. 2010 Jun;7(3):179-85. doi: 10.3109/15412555.2010.481695.
Marchand E. Effect of pharmacotherapy on rate of decline of FEV(1) in the TORCH study. Am J Respir Crit Care Med. 2009 Mar 1;179(5):426; author reply 426-7. doi: 10.1164/ajrccm.179.5.426. No abstract available.
McGarvey LP, John M, Anderson JA, Zvarich M, Wise RA; TORCH Clinical Endpoint Committee. Ascertainment of cause-specific mortality in COPD: operations of the TORCH Clinical Endpoint Committee. Thorax. 2007 May;62(5):411-5. doi: 10.1136/thx.2006.072348. Epub 2007 Feb 20.
Middleton PG. Management of patients with COPD: a comparison of the INSPIRE and TORCH studies. Am J Respir Crit Care Med. 2008 Jul 1;178(1):106; author reply 106-7. doi: 10.1164/ajrccm.178.1.106. No abstract available.
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. Epub 2009 May 7.
Niewoehner DE. TORCH and UPLIFT: what has been learned from the COPD "mega-trials"? COPD. 2009 Feb;6(1):1-3. doi: 10.1080/15412550902723984.
Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Crim C, Willits LR, Yates JC, Vestbo J; TORCH Investigators. Cardiovascular events in patients with COPD: TORCH study results. Thorax. 2010 Aug;65(8):719-25. doi: 10.1136/thx.2010.136077.
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 May;25(5):1235-45. doi: 10.1185/03007990902868971.
Suissa S, Ernst P, Vandemheen KL, Aaron SD. Methodological issues in therapeutic trials of COPD. Eur Respir J. 2008 May;31(5):927-33. doi: 10.1183/09031936.00098307. Epub 2008 Jan 23.
Vestbo J; TORCH Study Group. The TORCH (towards a revolution in COPD health) survival study protocol. Eur Respir J. 2004 Aug;24(2):206-10. doi: 10.1183/09031936.04.00120603.
Vestbo J, Anderson JA, Calverley PM, Celli B, Ferguson GT, Jenkins C, Knobil K, Willits LR, Yates JC, Jones PW. Adherence to inhaled therapy, mortality and hospital admission in COPD. Thorax. 2009 Nov;64(11):939-43. doi: 10.1136/thx.2009.113662. Epub 2009 Aug 23.
Paly VF, Naya I, Gunsoy NB, Driessen MT, Risebrough N, Briggs A, Ismaila AS. Long-term cost and utility consequences of short-term clinically important deterioration in patients with chronic obstructive pulmonary disease: results from the TORCH study. Int J Chron Obstruct Pulmon Dis. 2019 May 3;14:939-951. doi: 10.2147/COPD.S188898. eCollection 2019.
Naya IP, Tombs L, Muellerova H, Compton C, Jones PW. Long-term outcomes following first short-term clinically important deterioration in COPD. Respir Res. 2018 Nov 20;19(1):222. doi: 10.1186/s12931-018-0928-3.
Jenkins CR, Celli B, Anderson JA, Ferguson GT, Jones PW, Vestbo J, Yates JC, Calverley PM. Seasonality and determinants of moderate and severe COPD exacerbations in the TORCH study. Eur Respir J. 2012 Jan;39(1):38-45. doi: 10.1183/09031936.00194610. Epub 2011 Jul 7.
Jones PW, Anderson JA, Calverley PM, Celli BR, Ferguson GT, Jenkins C, Yates JC, Vestbo J, Spencer MD; TORCH investigators. Health status in the TORCH study of COPD: treatment efficacy and other determinants of change. Respir Res. 2011 May 31;12(1):71. doi: 10.1186/1465-9921-12-71.
Celli B, Vestbo J, Jenkins CR, Jones PW, Ferguson GT, Calverley PM, Yates JC, Anderson JA, Willits LR, Wise RA; Investigators of the TORCH Study. Sex differences in mortality and clinical expressions of patients with chronic obstructive pulmonary disease. The TORCH experience. Am J Respir Crit Care Med. 2011 Feb 1;183(3):317-22. doi: 10.1164/rccm.201004-0665OC. Epub 2010 Sep 2.
Study Documents
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Document Type: Annotated Case Report Form
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View DocumentDocument Type: Informed Consent Form
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View DocumentDocument Type: Clinical Study Report
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View DocumentDocument Type: Dataset Specification
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View DocumentDocument Type: Study Protocol
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View DocumentDocument Type: Individual Participant Data Set
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View DocumentDocument Type: Statistical Analysis Plan
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Other Identifiers
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SCO30003
Identifier Type: -
Identifier Source: org_study_id
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