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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00268216
Other study ID # SCO30003
Secondary ID
Status Completed
Phase Phase 3
First received December 20, 2005
Last updated January 19, 2017
Start date September 2000
Est. completion date November 2005

Study information

Verified date January 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

A multicenter, randomized, double-blind, parallel group, placebo controlled study to investigate the effects of salmeterol/fluticasone 50/500mcg bd, salmeterol 50mcg bd, and fluticasone 500mcg bd, all delivered via the DISKUS/ACCUHALER inhaler, on the survival of subjects with chronic obstructive pulmonary disease over 3 years of treatment.


Recruitment information / eligibility

Status Completed
Enrollment 6228
Est. completion date November 2005
Est. primary completion date November 2005
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Salmeterol 50mcg/ Fluticasone Propionate 500mcg


Locations

Country Name City State
GSK Investigational Site
Argentina GSK Investigational Site Buenos Aires
Argentina GSK Investigational Site La Plata Buenos Aires
Argentina GSK Investigational Site Vicente López Buenos Aires
Australia GSK Investigational Site Adelaide South Australia
Australia GSK Investigational Site Bankstown New South Wales
Australia GSK Investigational Site Camperdown New South Wales
Australia GSK Investigational Site Frankston Victoria
Australia GSK Investigational Site Geelong Victoria
Australia GSK Investigational Site Heidelberg Victoria
Australia GSK Investigational Site Melbourne Victoria
Australia GSK Investigational Site Melbourne Victoria
Australia GSK Investigational Site Nedlands Western Australia
Australia GSK Investigational Site North Gosford New South Wales
Australia GSK Investigational Site Toorak Gardens South Australia
Austria GSK Investigational Site Vienna
Austria GSK Investigational Site Vienna
Austria GSK Investigational Site Vienna
Austria GSK Investigational Site Wels
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Namur
Belgium GSK Investigational Site Oostende
Belgium GSK Investigational Site Orp-Jauche
Belgium GSK Investigational Site Veurne
Brazil GSK Investigational Site Porto Alegre Rio Grande Do Sul
Brazil GSK Investigational Site Porto Alegre Rio Grande Do Sul
Brazil GSK Investigational Site Rio de Janeiro
Brazil GSK Investigational Site Rio de Janeiro
Brazil GSK Investigational Site Rio de Janeiro
Brazil GSK Investigational Site Santo Andre São Paulo
Brazil GSK Investigational Site São Paulo
Bulgaria GSK Investigational Site Pleven
Bulgaria GSK Investigational Site Russe
Bulgaria GSK Investigational Site Sofia
Bulgaria GSK Investigational Site Sofia
Bulgaria GSK Investigational Site Varna
Canada GSK Investigational Site Calgary Alberta
Canada GSK Investigational Site Calgary Alberta
Canada GSK Investigational Site Edmonton Alberta
Canada GSK Investigational Site Maple Ridge British Columbia
Canada GSK Investigational Site Mississauga Ontario
Canada GSK Investigational Site Mississauga Ontario
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Quebec
Canada GSK Investigational Site Saint John New Brunswick
Canada GSK Investigational Site Saint John's Newfoundland and Labrador
Canada GSK Investigational Site Sainte-Foy Quebec
Canada GSK Investigational Site Scarborough Ontario
Canada GSK Investigational Site Sherbrooke Quebec
Canada GSK Investigational Site Sherbrooke Quebec
Canada GSK Investigational Site Thunder Bay Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Windsor Ontario
Chile GSK Investigational Site Santiago Región Metro De Santiago
Chile GSK Investigational Site Temuco Región De La Araucania
Chile GSK Investigational Site Valparaiso Valparaíso
China GSK Investigational Site Beijing
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Croatia GSK Investigational Site Zagreb
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Czech Republic GSK Investigational Site Jaromer
Czech Republic GSK Investigational Site Ostrava - Fifejdy
Czech Republic GSK Investigational Site Praha 5
Czech Republic GSK Investigational Site Praha 8
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Czech Republic GSK Investigational Site Tabor
Denmark GSK Investigational Site Aarhus C
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Estonia GSK Investigational Site Kohtal-Jdrve
Estonia GSK Investigational Site Tallinn
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Finland GSK Investigational Site Helsinki
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France GSK Investigational Site Marseille Cedex 20
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France GSK Investigational Site Paris Cedex 04
France GSK Investigational Site Saint Quentin
France GSK Investigational Site Tarbes Cedex 09
France GSK Investigational Site Toulouse Cedex 9
France GSK Investigational Site Tours Cedex 1
France GSK Investigational Site Verdun
Germany GSK Investigational Site Bad Segeberg Schleswig-Holstein
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Bielefeld Nordrhein-Westfalen
Germany GSK Investigational Site Darmstadt Hessen
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Germany GSK Investigational Site Kassel Hessen
Germany GSK Investigational Site Schwetzingen Baden-Wuerttemberg
Greece GSK Investigational Site Athens
Greece GSK Investigational Site Chania, Crete
Greece GSK Investigational Site Heraklion, Crete
Greece GSK Investigational Site Heraklion, Crete
Greece GSK Investigational Site Kavala
Greece GSK Investigational Site Larisa
Greece GSK Investigational Site Maroussi, Athens
Greece GSK Investigational Site N. Efkarpia, Thessaloniki
Greece GSK Investigational Site Papagos/Athens
Greece GSK Investigational Site Patra
Greece GSK Investigational Site Thessaloniki
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Hong Kong GSK Investigational Site Aberdeen
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Hong Kong GSK Investigational Site Tai Po,
Hungary GSK Investigational Site Budapest
Hungary GSK Investigational Site Cegléd
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Pakistan GSK Investigational Site Lahore
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Poland GSK Investigational Site Bialystok
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Puerto Rico GSK Investigational Site Ponce
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Sweden GSK Investigational Site Boden
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Sweden GSK Investigational Site Lidköping
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Taiwan GSK Investigational Site Tau-Yuan County
Thailand GSK Investigational Site Bangkok
Thailand GSK Investigational Site ChiangMai
Ukraine GSK Investigational Site Kiev
United Kingdom GSK Investigational Site Bristol Gloucestershire
United Kingdom GSK Investigational Site Exeter Devon
United Kingdom GSK Investigational Site Headington Oxfordshire
United Kingdom GSK Investigational Site Liverpool Lancashire
United Kingdom GSK Investigational Site London
United Kingdom GSK Investigational Site Manchester Lancashire
United Kingdom GSK Investigational Site Newcastle Upon Tyne Northumberland
United States GSK Investigational Site Albany New York
United States GSK Investigational Site Albany New York
United States GSK Investigational Site Albuquerque New Mexico
United States GSK Investigational Site Allentown Pennsylvania
United States GSK Investigational Site Altamonte Springs Florida
United States GSK Investigational Site Arvada Colorado
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Atlantis Florida
United States GSK Investigational Site Auburn Maine
United States GSK Investigational Site Augusta Georgia
United States GSK Investigational Site Baltimore Maryland
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United States GSK Investigational Site Bay Pines Florida
United States GSK Investigational Site Bellingham Washington
United States GSK Investigational Site Berkeley California
United States GSK Investigational Site Billings Montana
United States GSK Investigational Site Birmingham Alabama
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United States GSK Investigational Site Blue Ridge Georgia
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Brandon Florida
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United States GSK Investigational Site Bronxville New York
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United States GSK Investigational Site Burbank California
United States GSK Investigational Site Cadillac Michigan
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Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Croatia,  Czech Republic,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Iceland,  Italy,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Pakistan,  Philippines,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

References & Publications (23)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ernst P, Suissa S. Pneumonia in elderly patients with chronic obstructive pulmonary disease. Curr Infect Dis Rep. 2008 May;10(3):223-8. — View Citation

Ferguson GT, Calverley PM, 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):1456-65. doi: 10.1378/chest.08-3016. — View Citation

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. Review. — View Citation

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;8:52. — View Citation

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;10:59. doi: 10.1186/1465-9921-10-59. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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 . Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 23 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary All cause mortality at 3 years
Secondary Rate of moderate and severe COPD exacerbations and health status assessed by the St. George's Respiratory Questionnaire.
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