Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268216
• Other study ID #: SCO30003
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Chongqing
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Nanjing	Jiangsu
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shenyang	Liaoning
China	GSK Investigational Site	Wangfujing, Beijing
China	GSK Investigational Site	Xian	Shaanxi
Croatia	GSK Investigational Site	Zagreb
Czech Republic	GSK Investigational Site	Hradec Kralove
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
Czech Republic	GSK Investigational Site	Praha 8
Czech Republic	GSK Investigational Site	Tabor
Denmark	GSK Investigational Site	Aarhus C
Denmark	GSK Investigational Site	Hvidovre
Denmark	GSK Investigational Site	Kobenhavn NV
Denmark	GSK Investigational Site	Silkenborg
Estonia	GSK Investigational Site	Kohtal-Jdrve
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Kinkomaa
Finland	GSK Investigational Site	Lappeenranta
Finland	GSK Investigational Site	Lohja
Finland	GSK Investigational Site	Mikkeli
Finland	GSK Investigational Site	Oulainen
Finland	GSK Investigational Site	Pori
Finland	GSK Investigational Site	Vantaa
France	GSK Investigational Site	Annonay
France	GSK Investigational Site	Avrille
France	GSK Investigational Site	Bethune Cedex
France	GSK Investigational Site	Bois Guillaume
France	GSK Investigational Site	Caen Cedex
France	GSK Investigational Site	Chamalières
France	GSK Investigational Site	Cholet
France	GSK Investigational Site	Corbeil Essonne
France	GSK Investigational Site	Ferolles Attilly
France	GSK Investigational Site	Grenoble
France	GSK Investigational Site	Lille
France	GSK Investigational Site	Lomme
France	GSK Investigational Site	Marseille Cedex 20
France	GSK Investigational Site	Maurepas
France	GSK Investigational Site	Meaux
France	GSK Investigational Site	Nantes
France	GSK Investigational Site	Nimes
France	GSK Investigational Site	Nimes
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
Germany	GSK Investigational Site	Hannover	Niedersachsen
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
Greece	GSK Investigational Site	Thessaloniki
Hong Kong	GSK Investigational Site	Aberdeen
Hong Kong	GSK Investigational Site	Kowloon
Hong Kong	GSK Investigational Site	Kwun Tong
Hong Kong	GSK Investigational Site	Lai Chi kok
Hong Kong	GSK Investigational Site	Tai Po,
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Cegléd
Hungary	GSK Investigational Site	Dunaujvaros
Hungary	GSK Investigational Site	Szolnok
Hungary	GSK Investigational Site	Tatabanya
Hungary	GSK Investigational Site	Törökbálint
Iceland	GSK Investigational Site	Fossvogur. Reykjavic
Iceland	GSK Investigational Site	Reykjavik
Italy	GSK Investigational Site	Brescia	Lombardia
Italy	GSK Investigational Site	Bussolengo (VR)	Veneto
Italy	GSK Investigational Site	Ferrara	Emilia-Romagna
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Pisa	Toscana
Italy	GSK Investigational Site	Sesto San Giovanni (MI)	Lombardia
Italy	GSK Investigational Site	Tradate (VA)	Lombardia
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Lithuania	GSK Investigational Site	Kaunas
Malaysia	GSK Investigational Site	Kuala Lumpur
Malaysia	GSK Investigational Site	Kubang Kerian
Malaysia	GSK Investigational Site	Kuching
Malaysia	GSK Investigational Site	Tanjong Bungah
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Mexico
Mexico	GSK Investigational Site	Mexico, D.F.
Netherlands	GSK Investigational Site	Arnhem
Netherlands	GSK Investigational Site	Bilthoven
Netherlands	GSK Investigational Site	Breda
Netherlands	GSK Investigational Site	Dordrecht
Netherlands	GSK Investigational Site	EDE
Netherlands	GSK Investigational Site	Heerlen
Netherlands	GSK Investigational Site	Hengelo
Netherlands	GSK Investigational Site	Hoofddorp
Netherlands	GSK Investigational Site	Roosendaal
Netherlands	GSK Investigational Site	Terneuzen
Netherlands	GSK Investigational Site	Utrecht
Netherlands	GSK Investigational Site	Zwolle
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Hamilton
New Zealand	GSK Investigational Site	Tauranga
New Zealand	GSK Investigational Site	Wellington
New Zealand	GSK Investigational Site	Wellington South
Norway	GSK Investigational Site	Alesund
Norway	GSK Investigational Site	Bardufoss
Norway	GSK Investigational Site	Bergen
Norway	GSK Investigational Site	Bodo
Norway	GSK Investigational Site	Harstad
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Sandvika
Norway	GSK Investigational Site	Skien
Norway	GSK Investigational Site	Tonsberg
Norway	GSK Investigational Site	Trondheim
Norway	GSK Investigational Site	Volda
Pakistan	GSK Investigational Site	Lahore
Philippines	GSK Investigational Site	Cebu City
Philippines	GSK Investigational Site	Manila
Philippines	GSK Investigational Site	Manila
Philippines	GSK Investigational Site	Quezon City
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Wroclaw
Poland	GSK Investigational Site	Zabrze
Puerto Rico	GSK Investigational Site	Ponce
Romania	GSK Investigational Site	Brasov
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Iasi
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Singapore	GSK Investigational Site	Singapore
Singapore	GSK Investigational Site	Singapore
Singapore	GSK Investigational Site	Singapore
Singapore	GSK Investigational Site	Singapore
Slovakia	GSK Investigational Site	Banska Bystrica
Slovakia	GSK Investigational Site	Kralovsky Chlmec
Slovakia	GSK Investigational Site	Nove Zamky
Slovakia	GSK Investigational Site	Partizanske
South Africa	GSK Investigational Site	Cape Town
South Africa	GSK Investigational Site	Cape Town
South Africa	GSK Investigational Site	Durban	KwaZulu- Natal
South Africa	GSK Investigational Site	Mowbray
South Africa	GSK Investigational Site	Pretoria
South Africa	GSK Investigational Site	Pretoria
Spain	GSK Investigational Site	Alicante
Spain	GSK Investigational Site	Barakaldo (Vizcaya)
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Cadiz
Spain	GSK Investigational Site	Cartagena
Spain	GSK Investigational Site	Elda
Spain	GSK Investigational Site	Guadalajara
Spain	GSK Investigational Site	La Coruña
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Orihuela/Alicante
Spain	GSK Investigational Site	Santiago De Compostela
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Vigo/Pontevedra
Spain	GSK Investigational Site	Vizcaya
Sweden	GSK Investigational Site	Boden
Sweden	GSK Investigational Site	Eksjö
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Helsingborg
Sweden	GSK Investigational Site	Helsingborg
Sweden	GSK Investigational Site	Lidköping
Sweden	GSK Investigational Site	Trollhättan
Taiwan	GSK Investigational Site	Kaohsiung
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Tainan
Taiwan	GSK Investigational Site	Taipei
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
United States	GSK Investigational Site	Baltimore	Maryland
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
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Blue Ridge	Georgia
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Brandon	Florida
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Bronxville	New York
United States	GSK Investigational Site	Brooklyn	New York
United States	GSK Investigational Site	Buffalo	New York
United States	GSK Investigational Site	Burbank	California
United States	GSK Investigational Site	Cadillac	Michigan
United States	GSK Investigational Site	Champaign	Illinois
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charleston	West Virginia
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chesapeake	Virginia
United States	GSK Investigational Site	Chesterfield	Missouri
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Coeur D'Alene	Idaho
United States	GSK Investigational Site	Corsicana	Texas
United States	GSK Investigational Site	Cranston	Rhode Island
United States	GSK Investigational Site	Decatur	Georgia
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Downington	Pennsylvania
United States	GSK Investigational Site	Doylestown	Pennsylvania
United States	GSK Investigational Site	Dubuque	Iowa
United States	GSK Investigational Site	East Orange	New Jersey
United States	GSK Investigational Site	East Providence	Rhode Island
United States	GSK Investigational Site	Edina	Minnesota
United States	GSK Investigational Site	Elizabeth City	North Carolina
United States	GSK Investigational Site	Encinitas	California
United States	GSK Investigational Site	Erie	Pennsylvania
United States	GSK Investigational Site	Fort Collins	Colorado
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Franklin	Ohio
United States	GSK Investigational Site	Fredericksburg	Virginia
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Fullerton	California
United States	GSK Investigational Site	Gilford	New Hampshire
United States	GSK Investigational Site	Great Neck	New York
United States	GSK Investigational Site	Greenville	North Carolina
United States	GSK Investigational Site	Greer	South Carolina
United States	GSK Investigational Site	Hartford	Connecticut
United States	GSK Investigational Site	High Point	North Carolina
United States	GSK Investigational Site	Hines	Illinois
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntington	West Virginia
United States	GSK Investigational Site	Jackson	Mississippi
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jasper	Alabama
United States	GSK Investigational Site	Jefferson City	Missouri
United States	GSK Investigational Site	Johnson City	Tennessee
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Kingsport	Tennessee
United States	GSK Investigational Site	La Crosse	Wisconsin
United States	GSK Investigational Site	Lafayette	Louisiana
United States	GSK Investigational Site	Lake Oswego	Oregon
United States	GSK Investigational Site	Largo	Florida
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Lebanon	New Hampshire
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Livonia	Michigan
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Longmont	Colorado
United States	GSK Investigational Site	Longwood	Florida
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Loveland	Colorado
United States	GSK Investigational Site	Loxahatchee	Florida
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Marietta	Georgia
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Milan	Tennessee
United States	GSK Investigational Site	Mineola	New York
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Morristown	Tennessee
United States	GSK Investigational Site	New Brunswick	New Jersey
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newark	New Jersey
United States	GSK Investigational Site	North Chicago	Illinois
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Ozark	Alabama
United States	GSK Investigational Site	Pace	Florida
United States	GSK Investigational Site	Palm Springs	Florida
United States	GSK Investigational Site	Pensacola	Florida
United States	GSK Investigational Site	Peoria	Illinois
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Pueblo	Colorado
United States	GSK Investigational Site	Rancho Mirage	California
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Ridley Park	Pennsylvania
United States	GSK Investigational Site	Riverside	California
United States	GSK Investigational Site	Roanoke	Virginia
United States	GSK Investigational Site	Rome	Georgia
United States	GSK Investigational Site	Roswell	Georgia
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	San Luis Obispo	California
United States	GSK Investigational Site	Sarasota	Florida
United States	GSK Investigational Site	Scottsdale	Arizona
United States	GSK Investigational Site	Sepuldeva	California
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	Simpsonville	South Carolina
United States	GSK Investigational Site	South Bend	Indiana
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	St. Charles	Missouri
United States	GSK Investigational Site	St. Joseph	Michigan
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Stamford	Connecticut
United States	GSK Investigational Site	Stockton	California
United States	GSK Investigational Site	Summit	New Jersey
United States	GSK Investigational Site	Sunnyvale	California
United States	GSK Investigational Site	Sunset	Louisiana
United States	GSK Investigational Site	Swansea	Massachusetts
United States	GSK Investigational Site	Sylmar	California
United States	GSK Investigational Site	Tamarac	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Traverse City	Michigan
United States	GSK Investigational Site	Trenton	New Jersey
United States	GSK Investigational Site	Virginia Beach	Virginia
United States	GSK Investigational Site	Vista	California
United States	GSK Investigational Site	Walnut Creek	California
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Wheat Ridge	Colorado
United States	GSK Investigational Site	Wichita	Kansas
United States	GSK Investigational Site	Wichita	Kansas
United States	GSK Investigational Site	Wilmington	North Carolina
United States	GSK Investigational Site	Winston-Salem	North Carolina
United States	GSK Investigational Site	Winston-Salem	North Carolina
United States	GSK Investigational Site	Zephyrhills	Florida

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 all — Click 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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