Clinical trial NCT00268216: Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: mortality
TORCH
SERETIDE
ADVAIR
COPD
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-12-22
Enrollment: 6228
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: All cause mortality at 3 years
Secondary outcomes:
measure: Rate of moderate and severe COPD exacerbations and health status assessed by the St. George's Respiratory Questionnaire.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Jasper
country: United States
facility: GSK Investigational Site
state: Alabama
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Ozark
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Berkeley
country: United States
facility: GSK Investigational Site
state: California
city: Burbank
country: United States
facility: GSK Investigational Site
state: California
city: Encinitas
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Fullerton
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Rancho Mirage
country: United States
facility: GSK Investigational Site
state: California
city: Riverside
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: San Luis Obispo
country: United States
facility: GSK Investigational Site
state: California
city: Sepuldeva
country: United States
facility: GSK Investigational Site
state: California
city: Stockton
country: United States
facility: GSK Investigational Site
state: California
city: Sunnyvale
country: United States
facility: GSK Investigational Site
state: California
city: Sylmar
country: United States
facility: GSK Investigational Site
state: California
city: Vista
country: United States
facility: GSK Investigational Site
state: California
city: Walnut Creek
country: United States
facility: GSK Investigational Site
state: California
city: Arvada
country: United States
facility: GSK Investigational Site
state: Colorado
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Fort Collins
country: United States
facility: GSK Investigational Site
state: Colorado
city: Longmont
country: United States
facility: GSK Investigational Site
state: Colorado
city: Loveland
country: United States
facility: GSK Investigational Site
state: Colorado
city: Pueblo
country: United States
facility: GSK Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: GSK Investigational Site
state: Colorado
city: Hartford
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Stamford
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Altamonte Springs
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlantis
country: United States
facility: GSK Investigational Site
state: Florida
city: Bay Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: Brandon
country: United States
facility: GSK Investigational Site
state: Florida
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Largo
country: United States
facility: GSK Investigational Site
state: Florida
city: Longwood
country: United States
facility: GSK Investigational Site
state: Florida
city: Loxahatchee
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Pace
country: United States
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state: Florida
city: Palm Springs
country: United States
facility: GSK Investigational Site
state: Florida
city: Pensacola
country: United States
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state: Florida
city: Sarasota
country: United States
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state: Florida
city: Tamarac
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state: Florida
city: Tampa
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state: Florida
city: West Palm Beach
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state: Florida
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state: Georgia
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country: United States
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state: Georgia
city: Blue Ridge
country: United States
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state: Georgia
city: Decatur
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state: Georgia
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Rome
country: United States
facility: GSK Investigational Site
state: Georgia
city: Roswell
country: United States
facility: GSK Investigational Site
state: Georgia
city: Coeur D'Alene
country: United States
facility: GSK Investigational Site
state: Idaho
city: Champaign
country: United States
facility: GSK Investigational Site
state: Illinois
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Hines
country: United States
facility: GSK Investigational Site
state: Illinois
city: North Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Peoria
country: United States
facility: GSK Investigational Site
state: Illinois
city: South Bend
country: United States
facility: GSK Investigational Site
state: Indiana
city: Dubuque
country: United States
facility: GSK Investigational Site
state: Iowa
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Lafayette
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Shreveport
country: United States
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state: Louisiana
city: Sunset
country: United States
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state: Louisiana
city: Auburn
country: United States
facility: GSK Investigational Site
state: Maine
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Swansea
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Cadillac
country: United States
facility: GSK Investigational Site
state: Michigan
city: Livonia
country: United States
facility: GSK Investigational Site
state: Michigan
city: St. Joseph
country: United States
facility: GSK Investigational Site
state: Michigan
city: Traverse City
country: United States
facility: GSK Investigational Site
state: Michigan
city: Edina
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Jackson
country: United States
facility: GSK Investigational Site
state: Mississippi
city: Chesterfield
country: United States
facility: GSK Investigational Site
state: Missouri
city: Jefferson City
country: United States
facility: GSK Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Missouri
city: St. Charles
country: United States
facility: GSK Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Billings
country: United States
facility: GSK Investigational Site
state: Montana
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Gilford
country: United States
facility: GSK Investigational Site
state: New Hampshire
city: Lebanon
country: United States
facility: GSK Investigational Site
state: New Hampshire
city: East Orange
country: United States
facility: GSK Investigational Site
state: New Jersey
city: New Brunswick
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Newark
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Summit
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Trenton
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Albany
country: United States
facility: GSK Investigational Site
state: New York
city: Albany
country: United States
facility: GSK Investigational Site
state: New York
city: Bronxville
country: United States
facility: GSK Investigational Site
state: New York
city: Brooklyn
country: United States
facility: GSK Investigational Site
state: New York
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
city: Great Neck
country: United States
facility: GSK Investigational Site
state: New York
city: Mineola
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Elizabeth City
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: High Point
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Franklin
country: United States
facility: GSK Investigational Site
state: Ohio
city: Toledo
country: United States
facility: GSK Investigational Site
state: Ohio
city: Toledo
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Lake Oswego
country: United States
facility: GSK Investigational Site
state: Oregon
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Allentown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Downington
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Doylestown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Ridley Park
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Cranston
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: East Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Greer
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Simpsonville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Johnson City
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Milan
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Morristown
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Corsicana
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Chesapeake
country: United States
facility: GSK Investigational Site
state: Virginia
city: Fredericksburg
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Roanoke
country: United States
facility: GSK Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: GSK Investigational Site
state: Virginia
city: Bellingham
country: United States
facility: GSK Investigational Site
state: Washington
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: Charleston
country: United States
facility: GSK Investigational Site
state: West Virginia
city: Huntington
country: United States
facility: GSK Investigational Site
state: West Virginia
city: La Crosse
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: La Plata
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Vicente López
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Bankstown
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Camperdown
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: North Gosford
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Toorak Gardens
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Frankston
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Geelong
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Heidelberg
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Vienna
country: Austria
facility: GSK Investigational Site
city: Vienna
country: Austria
facility: GSK Investigational Site
city: Vienna
country: Austria
facility: GSK Investigational Site
city: Wels
country: Austria
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Namur
country: Belgium
facility: GSK Investigational Site
city: Oostende
country: Belgium
facility: GSK Investigational Site
city: Orp-Jauche
country: Belgium
facility: GSK Investigational Site
city: Veurne
country: Belgium
facility: GSK Investigational Site
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Santo Andre
country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: GSK Investigational Site
city: Rio de Janeiro
country: Brazil
facility: GSK Investigational Site
city: Rio de Janeiro
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: Pleven
country: Bulgaria
facility: GSK Investigational Site
city: Russe
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Varna
country: Bulgaria
facility: GSK Investigational Site
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Maple Ridge
country: Canada
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state: British Columbia
city: Saint John
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Saint John's
country: Canada
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state: Newfoundland and Labrador
city: Mississauga
country: Canada
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state: Ontario
city: Mississauga
country: Canada
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state: Ontario
city: Scarborough
country: Canada
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state: Ontario
city: Thunder Bay
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city: Sherbrooke
country: Canada
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city: Temuco
country: Chile
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state: Región De La Araucania
city: Santiago
country: Chile
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state: Región Metro De Santiago
city: Valparaiso
country: Chile
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state: Valparaíso
city: Guangzhou
country: China
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state: Guangdong
city: Nanjing
country: China
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state: Jiangsu
city: Shenyang
country: China
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state: Liaoning
city: Xian
country: China
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state: Shaanxi
city: Beijing
country: China
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country: China
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facility: GSK Investigational Site
city: Beijing
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city: Chongqing
country: China
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city: Shanghai
country: China
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city: Wangfujing, Beijing
country: China
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city: Zagreb
country: Croatia
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city: Hradec Kralove
country: Czech Republic
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country: Czech Republic
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country: Czech Republic
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country: Czech Republic
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country: Czech Republic
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country: Denmark
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city: Hvidovre
country: Denmark
facility: GSK Investigational Site
city: Kobenhavn NV
country: Denmark
facility: GSK Investigational Site
city: Silkenborg
country: Denmark
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city: Kohtal-Jdrve
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
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city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Kinkomaa
country: Finland
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city: Lappeenranta
country: Finland
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country: Finland
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country: France
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country: France
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country: France
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country: France
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country: France
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city: Ferolles Attilly
country: France
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city: Grenoble
country: France
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city: Lille
country: France
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city: Lomme
country: France
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city: Marseille Cedex 20
country: France
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city: Maurepas
country: France
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city: Meaux
country: France
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city: Nantes
country: France
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city: Nimes
country: France
facility: GSK Investigational Site
city: Nimes
country: France
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city: Paris Cedex 04
country: France
facility: GSK Investigational Site
city: Saint Quentin
country: France
facility: GSK Investigational Site
city: Tarbes Cedex 09
country: France
facility: GSK Investigational Site
city: Toulouse Cedex 9
country: France
facility: GSK Investigational Site
city: Tours Cedex 1
country: France
facility: GSK Investigational Site
city: Verdun
country: France
facility: GSK Investigational Site
city: Schwetzingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Darmstadt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Kassel
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bielefeld
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bad Segeberg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Chania, Crete
country: Greece
facility: GSK Investigational Site
city: Heraklion, Crete
country: Greece
facility: GSK Investigational Site
city: Heraklion, Crete
country: Greece
facility: GSK Investigational Site
city: Kavala
country: Greece
facility: GSK Investigational Site
city: Larisa
country: Greece
facility: GSK Investigational Site
city: Maroussi, Athens
country: Greece
facility: GSK Investigational Site
city: N. Efkarpia, Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Papagos/Athens
country: Greece
facility: GSK Investigational Site
city: Patra
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Aberdeen
country: Hong Kong
facility: GSK Investigational Site
city: Kowloon
country: Hong Kong
facility: GSK Investigational Site
city: Kwun Tong
country: Hong Kong
facility: GSK Investigational Site
city: Lai Chi kok
country: Hong Kong
facility: GSK Investigational Site
city: Tai Po,
country: Hong Kong
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Cegléd
country: Hungary
facility: GSK Investigational Site
city: Dunaujvaros
country: Hungary
facility: GSK Investigational Site
city: Szolnok
country: Hungary
facility: GSK Investigational Site
city: Tatabanya
country: Hungary
facility: GSK Investigational Site
city: Törökbálint
country: Hungary
facility: GSK Investigational Site
city: Fossvogur. Reykjavic
country: Iceland
facility: GSK Investigational Site
city: Reykjavik
country: Iceland
facility: GSK Investigational Site
city: Ferrara
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Brescia
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Sesto San Giovanni (MI)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Tradate (VA)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Pisa
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Bussolengo (VR)
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: GSK Investigational Site
city: Kubang Kerian
country: Malaysia
facility: GSK Investigational Site
city: Kuching
country: Malaysia
facility: GSK Investigational Site
city: Tanjong Bungah
country: Malaysia
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Mexico, D.F.
country: Mexico
facility: GSK Investigational Site
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: Arnhem
country: Netherlands
facility: GSK Investigational Site
city: Bilthoven
country: Netherlands
facility: GSK Investigational Site
city: Breda
country: Netherlands
facility: GSK Investigational Site
city: Dordrecht
country: Netherlands
facility: GSK Investigational Site
city: EDE
country: Netherlands
facility: GSK Investigational Site
city: Heerlen
country: Netherlands
facility: GSK Investigational Site
city: Hengelo
country: Netherlands
facility: GSK Investigational Site
city: Hoofddorp
country: Netherlands
facility: GSK Investigational Site
city: Roosendaal
country: Netherlands
facility: GSK Investigational Site
city: Terneuzen
country: Netherlands
facility: GSK Investigational Site
city: Utrecht
country: Netherlands
facility: GSK Investigational Site
city: Zwolle
country: Netherlands
facility: GSK Investigational Site
city: Auckland
country: New Zealand
facility: GSK Investigational Site
city: Auckland
country: New Zealand
facility: GSK Investigational Site
city: Auckland
country: New Zealand
facility: GSK Investigational Site
city: Hamilton
country: New Zealand
facility: GSK Investigational Site
city: Tauranga
country: New Zealand
facility: GSK Investigational Site
city: Wellington South
country: New Zealand
facility: GSK Investigational Site
city: Wellington
country: New Zealand
facility: GSK Investigational Site
city: Alesund
country: Norway
facility: GSK Investigational Site
city: Bardufoss
country: Norway
facility: GSK Investigational Site
city: Bergen
country: Norway
facility: GSK Investigational Site
city: Bodo
country: Norway
facility: GSK Investigational Site
city: Harstad
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Sandvika
country: Norway
facility: GSK Investigational Site
city: Skien
country: Norway
facility: GSK Investigational Site
city: Tonsberg
country: Norway
facility: GSK Investigational Site
city: Trondheim
country: Norway
facility: GSK Investigational Site
city: Volda
country: Norway
facility: GSK Investigational Site
city: Lahore
country: Pakistan
facility: GSK Investigational Site
city: Cebu City
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Zabrze
country: Poland
facility: GSK Investigational Site
city: Ponce
country: Puerto Rico
facility: GSK Investigational Site
city: Brasov
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Iasi
country: Romania
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Banska Bystrica
country: Slovakia
facility: GSK Investigational Site
city: Kralovsky Chlmec
country: Slovakia
facility: GSK Investigational Site
city: Nove Zamky
country: Slovakia
facility: GSK Investigational Site
city: Partizanske
country: Slovakia
facility: GSK Investigational Site
city: Durban
country: South Africa
facility: GSK Investigational Site
state: KwaZulu- Natal
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Mowbray
country: South Africa
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
city: Alicante
country: Spain
facility: GSK Investigational Site
city: Barakaldo (Vizcaya)
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Cadiz
country: Spain
facility: GSK Investigational Site
city: Cartagena
country: Spain
facility: GSK Investigational Site
city: Elda
country: Spain
facility: GSK Investigational Site
city: Guadalajara
country: Spain
facility: GSK Investigational Site
city: La Coruña
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Orihuela/Alicante
country: Spain
facility: GSK Investigational Site
city: Santiago De Compostela
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Vigo/Pontevedra
country: Spain
facility: GSK Investigational Site
city: Vizcaya
country: Spain
facility: GSK Investigational Site
city: Boden
country: Sweden
facility: GSK Investigational Site
city: Eksjö
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Helsingborg
country: Sweden
facility: GSK Investigational Site
city: Helsingborg
country: Sweden
facility: GSK Investigational Site
city: Lidköping
country: Sweden
facility: GSK Investigational Site
city: Trollhättan
country: Sweden
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Tainan
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Tau-Yuan County
country: Taiwan
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: ChiangMai
country: Thailand
facility: GSK Investigational Site
city: Kiev
country: Ukraine
facility: GSK Investigational Site
city: Exeter
country: United Kingdom
facility: GSK Investigational Site
state: Devon
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
state: Gloucestershire
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Newcastle Upon Tyne
country: United Kingdom
facility: GSK Investigational Site
state: Northumberland
city: Headington
country: United Kingdom
facility: GSK Investigational Site
state: Oxfordshire
city: London
country: United Kingdom
facility: GSK Investigational Site
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
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. doi: 10.1056/NEJMoa063070.
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. Epub 2008 May 29.
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(1):59. doi: 10.1186/1465-9921-10-59.
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. Epub 2009 May 14.
citation: 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.
citation: 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.
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. Epub 2008 Jan 6.
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(1):52. doi: 10.1186/1465-9921-8-52.
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.
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.
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.
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. doi: 10.1164/ajrccm.179.5.426. No abstract available.
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. doi: 10.1136/thx.2006.072348. Epub 2007 Feb 20.
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. doi: 10.1164/ajrccm.178.1.106. No abstract available.
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. Epub 2009 May 7.
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.
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.
citation: Salmeterol plus fluticasone fails to reduce mortality in patients with COPD. Formulary 2007;42:245-6.
citation: 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.
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. Epub 2008 Jan 23.
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. doi: 10.1183/09031936.04.00120603.
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. Epub 2009 Aug 23.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.