AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 3NCT00268216

Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing Salmeterol 50mcg/ Fluticasone Propionate 500mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 459 sites in 45 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Salmeterol 50mcg/ Fluticasone Propionate 500mcg
How many people
6,228 participants
Where
459 sitesin 45 countries
Study dates
Sep 2000to Nov 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Diagnosis of other respiratory disorders (including asthma).
  • Requirement for long term oxygen therapy.

Trial locations and contacts

459 sites in 45 countries.

459 sites in 45 countries

United States190 sites

  • GSK Investigational Site

    Albany, New York, 12205

  • GSK Investigational Site

    Albany, New York, 12208

  • GSK Investigational Site

    Albuquerque, New Mexico, 87108

  • GSK Investigational Site

    Allentown, Pennsylvania, 18104

  • GSK Investigational Site

    Altamonte Springs, Florida, 32701

  • GSK Investigational Site

    Arvada, Colorado, 80002

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Atlantis, Florida, 33462

  • GSK Investigational Site

    Auburn, Maine, 04210

  • GSK Investigational Site

    Augusta, Georgia, 30901

  • GSK Investigational Site

    Baltimore, Maryland, 21204

  • GSK Investigational Site

    Baltimore, Maryland, 21224

  • GSK Investigational Site

    Bay Pines, Florida, 33744

  • GSK Investigational Site

    Bellingham, Washington, 98226

  • GSK Investigational Site

    Berkeley, California, 94705

  • GSK Investigational Site

    Billings, Montana, 59102

  • GSK Investigational Site

    Birmingham, Alabama, 35235

  • GSK Investigational Site

    Birmingham, Alabama, 35294-7340

  • GSK Investigational Site

    Birmingham, Alabama, 35294

  • GSK Investigational Site

    Blue Ridge, Georgia, 30513

  • GSK Investigational Site

    Boston, Massachusetts, 02135

  • GSK Investigational Site

    Brandon, Florida, 33511

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Bronxville, New York, 10708

  • GSK Investigational Site

    Brooklyn, New York, 11217

  • GSK Investigational Site

    Buffalo, New York, 14221

  • GSK Investigational Site

    Burbank, California, 91505

  • GSK Investigational Site

    Cadillac, Michigan, 49601

  • GSK Investigational Site

    Champaign, Illinois, 61821

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27514

  • GSK Investigational Site

    Charleston, South Carolina, 29403

  • GSK Investigational Site

    Charleston, South Carolina, 29406-7108

  • GSK Investigational Site

    Charleston, West Virginia, 25304

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Chesapeake, Virginia, 23320

  • GSK Investigational Site

    Chesterfield, Missouri, 63017

  • GSK Investigational Site

    Chicago, Illinois, 60612-3824

  • GSK Investigational Site

    Chicago, Illinois, 60612-7323

  • GSK Investigational Site

    Cincinnati, Ohio, 45219

  • GSK Investigational Site

    Cincinnati, Ohio, 45267-0405

  • GSK Investigational Site

    Clearwater, Florida, 33756

  • GSK Investigational Site

    Cleveland, Ohio, 44024

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    Corsicana, Texas, 75110

  • GSK Investigational Site

    Cranston, Rhode Island, 02920

  • GSK Investigational Site

    Decatur, Georgia, 30033

  • GSK Investigational Site

    Denver, Colorado, 80206

  • GSK Investigational Site

    Denver, Colorado, 80218

  • GSK Investigational Site

    Downington, Pennsylvania, 19335

  • GSK Investigational Site

    Doylestown, Pennsylvania, 8901

  • GSK Investigational Site

    Dubuque, Iowa, 52001

  • GSK Investigational Site

    East Orange, New Jersey, 07018

  • GSK Investigational Site

    East Providence, Rhode Island, 02914

  • GSK Investigational Site

    Edina, Minnesota, 55438

  • GSK Investigational Site

    Elizabeth City, North Carolina, 27909

  • GSK Investigational Site

    Encinitas, California, 92024

  • GSK Investigational Site

    Erie, Pennsylvania, 16508

  • GSK Investigational Site

    Fort Collins, Colorado, 80528

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33316

  • GSK Investigational Site

    Franklin, Ohio, 45005

  • GSK Investigational Site

    Fredericksburg, Virginia, 22401

  • GSK Investigational Site

    Fresno, California, 93710

  • GSK Investigational Site

    Fullerton, California, 92835

  • GSK Investigational Site

    Gilford, New Hampshire, 3249

  • GSK Investigational Site

    Great Neck, New York, 11023

  • GSK Investigational Site

    Greenville, North Carolina, 27834

  • GSK Investigational Site

    Greer, South Carolina, 29651

  • GSK Investigational Site

    Hartford, Connecticut, 06105

  • GSK Investigational Site

    High Point, North Carolina, 27262

  • GSK Investigational Site

    Hines, Illinois, 60141-5099

  • GSK Investigational Site

    Houston, Texas, 77024

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Houston, Texas, 77074

  • GSK Investigational Site

    Huntington, West Virginia, 25701-1693

  • GSK Investigational Site

    Jackson, Mississippi, 39202

  • GSK Investigational Site

    Jacksonville, Florida, 32205

  • GSK Investigational Site

    Jacksonville, Florida, 32216

  • GSK Investigational Site

    Jasper, Alabama, 35501

  • GSK Investigational Site

    Jefferson City, Missouri, 65109

  • GSK Investigational Site

    Johnson City, Tennessee, 37601

  • GSK Investigational Site

    Kansas City, Missouri, 64108

  • GSK Investigational Site

    Kingsport, Tennessee, 37660

  • GSK Investigational Site

    La Crosse, Wisconsin, 54601

  • GSK Investigational Site

    Lafayette, Louisiana, 70503

  • GSK Investigational Site

    Lake Oswego, Oregon, 97035

  • GSK Investigational Site

    Largo, Florida, 33770

  • GSK Investigational Site

    Las Vegas, Nevada, 89104

  • GSK Investigational Site

    Lebanon, New Hampshire, 03756

  • GSK Investigational Site

    Lexington, Kentucky, 40536

  • GSK Investigational Site

    Livonia, Michigan, 48152

  • GSK Investigational Site

    Long Beach, California, 90822

  • GSK Investigational Site

    Longmont, Colorado, 80501

  • GSK Investigational Site

    Longwood, Florida, 32779

  • GSK Investigational Site

    Los Angeles, California, 90033

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Louisville, Kentucky, 40215

  • GSK Investigational Site

    Loveland, Colorado, 80538

  • GSK Investigational Site

    Loxahatchee Groves, Florida, 33470

  • GSK Investigational Site

    Madison, Wisconsin, 53705

  • GSK Investigational Site

    Marietta, Georgia, 30066

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Milan, Tennessee, 38372

  • GSK Investigational Site

    Mineola, New York, 11501

  • GSK Investigational Site

    Minneapolis, Minnesota, 55417

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    Morristown, Tennessee, 37813

  • GSK Investigational Site

    New Brunswick, New Jersey, 8901

  • GSK Investigational Site

    New York, New York, 10011

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    New York, New York, 10025

  • GSK Investigational Site

    New York, New York, 10029

  • GSK Investigational Site

    Newark, New Jersey, 07112

  • GSK Investigational Site

    North Chicago, Illinois, 60064

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104

  • GSK Investigational Site

    Omaha, Nebraska, 68105

  • GSK Investigational Site

    Omaha, Nebraska, 68124

  • GSK Investigational Site

    Omaha, Nebraska, 68134

  • GSK Investigational Site

    Omaha, Nebraska, 68198-2456

  • GSK Investigational Site

    Omaha, Nebraska, 68198

  • GSK Investigational Site

    Ozark, Alabama, 36360

  • GSK Investigational Site

    Pace, Florida, 32571

  • GSK Investigational Site

    Palm Springs, Florida, 33461

  • GSK Investigational Site

    Pensacola, Florida, 32514

  • GSK Investigational Site

    Peoria, Illinois, 61602

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19129

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19140

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19148

  • GSK Investigational Site

    Phoenix, Arizona, 85006

  • GSK Investigational Site

    Phoenix, Arizona, 85008

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15218

  • GSK Investigational Site

    Portland, Oregon, 97213-2281

  • GSK Investigational Site

    Portland, Oregon, 97213

  • GSK Investigational Site

    Pueblo, Colorado, 81001

  • GSK Investigational Site

    Rancho Mirage, California, 92270

  • GSK Investigational Site

    Richmond, Virginia, 23225

  • GSK Investigational Site

    Richmond, Virginia, 23249

  • GSK Investigational Site

    Ridley Park, Pennsylvania, 19078

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Roanoke, Virginia, 24016

  • GSK Investigational Site

    Rome, Georgia, 30165

  • GSK Investigational Site

    Roswell, Georgia, 30076

  • GSK Investigational Site

    Saint Charles, Missouri, 63301

  • GSK Investigational Site

    Saint Joseph, Michigan, 49085

  • GSK Investigational Site

    Salt Lake City, Utah, 84102

  • GSK Investigational Site

    San Antonio, Texas, 78205

  • GSK Investigational Site

    San Antonio, Texas, 78217

  • GSK Investigational Site

    San Diego, California, 92103-6204

  • GSK Investigational Site

    San Diego, California, 92103

  • GSK Investigational Site

    San Diego, California, 92117

  • GSK Investigational Site

    San Diego, California, 92120

  • GSK Investigational Site

    San Diego, California, 92123

  • GSK Investigational Site

    San Francisco, California, 94102

  • GSK Investigational Site

    San Luis Obispo, California, 93401

  • GSK Investigational Site

    Sarasota, Florida, 34239

  • GSK Investigational Site

    Scottsdale, Arizona, 85251

  • GSK Investigational Site

    Sepuldeva, California, 91343

  • GSK Investigational Site

    Shreveport, Louisiana, 71103

  • GSK Investigational Site

    Simpsonville, South Carolina, 29681

  • GSK Investigational Site

    South Bend, Indiana, 46617

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Spokane, Washington, 99202

  • GSK Investigational Site

    Spokane, Washington, 99204

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Stamford, Connecticut, 06902

  • GSK Investigational Site

    Stockton, California, 95207

  • GSK Investigational Site

    Summit, New Jersey, 07091

  • GSK Investigational Site

    Sunnyvale, California, 94086

  • GSK Investigational Site

    Sunset, Louisiana, 70584

  • GSK Investigational Site

    Swansea, Massachusetts, 02777

  • GSK Investigational Site

    Sylmar, California, 91342-1495

  • GSK Investigational Site

    Tamarac, Florida, 33321

  • GSK Investigational Site

    Tampa, Florida, 33613

  • GSK Investigational Site

    Toledo, Ohio, 43614-5809

  • GSK Investigational Site

    Toledo, Ohio, 43617

  • GSK Investigational Site

    Traverse City, Michigan, 49684

  • GSK Investigational Site

    Trenton, New Jersey, 8629

  • GSK Investigational Site

    Virginia Beach, Virginia, 23454

  • GSK Investigational Site

    Vista, California, 92083

  • GSK Investigational Site

    Walnut Creek, California, 94598

  • GSK Investigational Site

    West Palm Beach, Florida, 33409

  • GSK Investigational Site

    Wheat Ridge, Colorado, 80033

  • GSK Investigational Site

    Wichita, Kansas, 67207

  • GSK Investigational Site

    Wichita, Kansas, 67208

  • GSK Investigational Site

    Wilmington, North Carolina, 28401

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27157

  • GSK Investigational Site

    Zephyrhills, Florida, 33540

Other trials in United States

France24 sites

  • GSK Investigational Site

    Annonay, 07100

  • GSK Investigational Site

    Avrillé, 49240

  • GSK Investigational Site

    Béthune, 62408

  • GSK Investigational Site

    Bois-Guillaume, 76230

  • GSK Investigational Site

    Caen, 14050

  • GSK Investigational Site

    Chamalières, 63400

  • GSK Investigational Site

    Cholet, 49300

  • GSK Investigational Site

    Corbeil Essonne, 91100

  • GSK Investigational Site

    Férolles-Attilly, 77150

  • GSK Investigational Site

    Grenoble, 38000

  • GSK Investigational Site

    Lille, 59800

  • GSK Investigational Site

    Lomme, 59160

  • GSK Investigational Site

    Marseille, 13915

  • GSK Investigational Site

    Maurepas, 78310

  • GSK Investigational Site

    Meaux, 77104

  • GSK Investigational Site

    Nantes, 44000

  • GSK Investigational Site

    Nîmes, 30000

  • GSK Investigational Site

    Nîmes, 30900

  • GSK Investigational Site

    Paris, 75181

  • GSK Investigational Site

    Saint-Quentin, 02100

  • GSK Investigational Site

    Tarbes, 65013

  • GSK Investigational Site

    Toulouse, 31059

  • GSK Investigational Site

    Tours, 37000

  • GSK Investigational Site

    Verdun, 55100

Other trials in France

Canada17 sites

  • GSK Investigational Site

    Calgary, Alberta, T2N 4N1

  • GSK Investigational Site

    Calgary, Alberta, T2V 1P9

  • GSK Investigational Site

    Edmonton, Alberta, T6L 5X8

  • GSK Investigational Site

    Maple Ridge, British Columbia, V2X 2L5

  • GSK Investigational Site

    Mississauga, Ontario, L5A 1N1

  • GSK Investigational Site

    Mississauga, Ontario, L5M 2V8

  • GSK Investigational Site

    Montreal, Quebec, H2X 2P4

  • GSK Investigational Site

    Québec, Quebec, G1S 4L8

  • GSK Investigational Site

    Saint John, New Brunswick, E2M 3W5

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1V 4G5

  • GSK Investigational Site

    Scarborough Village, Ontario, M1B 4Z8

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 1Z1

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 4J6

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • GSK Investigational Site

    Thunder Bay, Ontario, P7A 4V7

  • GSK Investigational Site

    Toronto, Ontario, M6H 3M2

  • GSK Investigational Site

    Windsor, Ontario, N8X 3V6

Other trials in Canada

Spain15 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Alicante

  • GSK Investigational Site

    Barakaldo (Vizcaya), 48903

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Cadiz, 11009

  • GSK Investigational Site

    Cartagena, 30203

  • GSK Investigational Site

    Elda, 03600

  • GSK Investigational Site

    Guadalajara, 19002

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Orihuela/Alicante, 03314

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Valencia, 46017

  • GSK Investigational Site

    Vigo/Pontevedra, 36200

  • GSK Investigational Site

    Vizcaya, 48902

Other trials in Spain

Norway14 sites

  • GSK Investigational Site

    Ålesund, 6026

  • GSK Investigational Site

    Bardufoss, 9325

  • GSK Investigational Site

    Bergen, 5053

  • GSK Investigational Site

    Bodø, N-8092

  • GSK Investigational Site

    Harstad, N-9480

  • GSK Investigational Site

    Oslo, 1150

  • GSK Investigational Site

    Oslo, N-0456

  • GSK Investigational Site

    Oslo, N-0514

  • GSK Investigational Site

    Oslo, N-1054

  • GSK Investigational Site

    Sandvika, 1337

  • GSK Investigational Site

    Skien, 3722

  • GSK Investigational Site

    Tønsberg, N-3117

  • GSK Investigational Site

    Trondheim, 7006

  • GSK Investigational Site

    Volda, 6100

Other trials in Norway

Greece12 sites

  • GSK Investigational Site

    Athens, 15669

  • GSK Investigational Site

    Chania, Crete, 73300

  • GSK Investigational Site

    Heraklion, Crete, 71110

  • GSK Investigational Site

    Heraklion, Crete, 71409

  • GSK Investigational Site

    Kavala, 65403

  • GSK Investigational Site

    Larissa, 41110

  • GSK Investigational Site

    Maroussi, Athens, 11526

  • GSK Investigational Site

    N. Efkarpia, Thessaloniki, 564 29

  • GSK Investigational Site

    Papagos/Athens, 15669

  • GSK Investigational Site

    Pátrai, 26226

  • GSK Investigational Site

    Thessaloniki, 54642

  • GSK Investigational Site

    Thessaloniki, 57010

Other trials in Greece

Netherlands12 sites

  • GSK Investigational Site

    Arnhem, 6815 AD

  • GSK Investigational Site

    Bilthoven, 3723

  • GSK Investigational Site

    Breda, 4819 EV

  • GSK Investigational Site

    Dordrecht, 3317 NM

  • GSK Investigational Site

    Ede, 6716 RP

  • GSK Investigational Site

    Heerlen, 6419 PC

  • GSK Investigational Site

    Hengelo, 7555 DL

  • GSK Investigational Site

    Hoofddorp, 2130 AT

  • GSK Investigational Site

    Roosendaal, 4708 AE

  • GSK Investigational Site

    Terneuzen, 4535 PA

  • GSK Investigational Site

    Utrecht, 2584 CX

  • GSK Investigational Site

    Zwolle, 8025 AB

Other trials in Netherlands

Australia11 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Bankstown, New South Wales, 22000

  • GSK Investigational Site

    Camperdown, New South Wales, 2050

  • GSK Investigational Site

    Frankston, Victoria, 3199

  • GSK Investigational Site

    Geelong, Victoria, 3220

  • GSK Investigational Site

    Heidelberg, Victoria, 3084

  • GSK Investigational Site

    Melbourne, Victoria, 3004

  • GSK Investigational Site

    Melbourne, Victoria, 3050

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    North Gosford, New South Wales, 2250

  • GSK Investigational Site

    Toorak Gardens, South Australia, 5065

Other trials in Australia

China11 sites

  • GSK Investigational Site

    Beijing, 100034

  • GSK Investigational Site

    Beijing, 100036

  • GSK Investigational Site

    Beijing, 100037

  • GSK Investigational Site

    Beijing, 100039

  • GSK Investigational Site

    Chongqing, 400037

  • GSK Investigational Site

    Guangzhou, Guangdong, 510120

  • GSK Investigational Site

    Nanjing, Jiangsu, 210002

  • GSK Investigational Site

    Shanghai, 200025

  • GSK Investigational Site

    Shenyang, Liaoning, 110015

  • GSK Investigational Site

    Wangfujing, Beijing, 100730

  • GSK Investigational Site

    Xi'an, Shaanxi, 710061

Other trials in China

Germany10 sites

  • GSK Investigational Site

    Bad Segeberg, Schleswig-Holstein, 23795

  • GSK Investigational Site

    Berlin, State of Berlin, 10178

  • GSK Investigational Site

    Berlin, State of Berlin, 10365

  • GSK Investigational Site

    Berlin, State of Berlin, 10559

  • GSK Investigational Site

    Berlin, State of Berlin, 13357

  • GSK Investigational Site

    Bielefeld, North Rhine-Westphalia, 33602

  • GSK Investigational Site

    Darmstadt, Hesse, 64287

  • GSK Investigational Site

    Hanover, Lower Saxony, 30167

  • GSK Investigational Site

    Kassel, Hesse, 34117

  • GSK Investigational Site

    Schwetzingen, Baden-Wurttemberg, 68723

Other trials in Germany

Finland9 sites

  • GSK Investigational Site

    Helsinki, 00029

  • GSK Investigational Site

    Helsinki, 00290

  • GSK Investigational Site

    Kinkomaa, 40930

  • GSK Investigational Site

    Lappeenranta, 53130

  • GSK Investigational Site

    Lohja, 08200

  • GSK Investigational Site

    Mikkeli, 50100

  • GSK Investigational Site

    Oulainen, 86300

  • GSK Investigational Site

    Pori, 28100

  • GSK Investigational Site

    Vantaa, 01400

Other trials in Finland

Brazil7 sites

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 40110-160

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035 003

  • GSK Investigational Site

    Rio de Janeiro, Rio de Janeiro, 20 551-030

  • GSK Investigational Site

    Rio de Janeiro, Rio de Janeiro, 20221-903

  • GSK Investigational Site

    Rio de Janeiro, Rio de Janeiro, 21941-590

  • GSK Investigational Site

    Santo André, São Paulo, 09060-670

  • GSK Investigational Site

    São Paulo, São Paulo, 05403-900

Other trials in Brazil

Czechia7 sites

  • GSK Investigational Site

    Hradec Králové, 500 05

  • GSK Investigational Site

    Jaroměř, 551 01

  • GSK Investigational Site

    Ostrava - Fifejdy, 728 80

  • GSK Investigational Site

    Prague, 150 06

  • GSK Investigational Site

    Prague, 180 81

  • GSK Investigational Site

    Prague, 182 00

  • GSK Investigational Site

    Tábor, 390 19

Other trials in Czechia

Italy7 sites

  • GSK Investigational Site

    Brescia, Lombardy, 25123

  • GSK Investigational Site

    Bussolengo (VR), Veneto, 37012

  • GSK Investigational Site

    Ferrara, Emilia-Romagna, 44100

  • GSK Investigational Site

    Milan, Lombardy, 20152

  • GSK Investigational Site

    Pisa, Tuscany, 56124

  • GSK Investigational Site

    Sesto San Giovanni (MI), Lombardy, 20099

  • GSK Investigational Site

    Tradate (VA), Lombardy, 21049

Other trials in Italy

New Zealand7 sites

  • GSK Investigational Site

    Auckland, 1001

  • GSK Investigational Site

    Auckland, 1005

  • GSK Investigational Site

    Auckland, 1701

  • GSK Investigational Site

    Hamilton, 2001

  • GSK Investigational Site

    Tauranga, 3001

  • GSK Investigational Site

    Wellington, 6035

  • GSK Investigational Site

    Wellington South, 6002

Other trials in New Zealand

Sweden7 sites

  • GSK Investigational Site

    Boden, SE-961 64

  • GSK Investigational Site

    Eksjö, SE-575 81

  • GSK Investigational Site

    Gothenburg, SE-413 45

  • GSK Investigational Site

    Helsingborg, SE-251 87

  • GSK Investigational Site

    Helsingborg, SE-252 26

  • GSK Investigational Site

    Lidköping, SE-531 85

  • GSK Investigational Site

    Trollhättan, SE-461 85

Other trials in Sweden

United Kingdom7 sites

  • GSK Investigational Site

    Bristol, Gloucestershire, BS16 2EW

  • GSK Investigational Site

    Exeter, Devon, EX2 5DW

  • GSK Investigational Site

    Headington, Oxfordshire, OX3 7LJ

  • GSK Investigational Site

    Liverpool, Lancashire, L9 7AL

  • GSK Investigational Site

    London, E1 1BB

  • GSK Investigational Site

    Manchester, Lancashire, M8 5RB

  • GSK Investigational Site

    Newcastle upon Tyne, Northumberland, NE1 4LP

Other trials in United Kingdom

Hungary6 sites

  • GSK Investigational Site

    Budapest, 1529

  • GSK Investigational Site

    Cegléd, 2700

  • GSK Investigational Site

    Dunaújváros, 2400

  • GSK Investigational Site

    Szolnok, 5004

  • GSK Investigational Site

    Tatabánya, 2800

  • GSK Investigational Site

    Törökbálint, 2045

Other trials in Hungary

South Africa6 sites

  • GSK Investigational Site

    Cape Town, 7505

  • GSK Investigational Site

    Cape Town, 8001

  • GSK Investigational Site

    Durban, KwaZulu-Natal, 4126

  • GSK Investigational Site

    Mowbray, 7700

  • GSK Investigational Site

    Pretoria, 0040

  • GSK Investigational Site

    Pretoria

Other trials in South Africa

Belgium5 sites

  • GSK Investigational Site

    Brussels, 1180

  • GSK Investigational Site

    Namur, 5000

  • GSK Investigational Site

    Orp-Jauche, 1350

  • GSK Investigational Site

    Ostend, 8400

  • GSK Investigational Site

    Veurne, 8630

Other trials in Belgium

Bulgaria5 sites

  • GSK Investigational Site

    Pleven, 5800

  • GSK Investigational Site

    Rousse, 7000

  • GSK Investigational Site

    Sofia, 1202

  • GSK Investigational Site

    Sofia, 1431

  • GSK Investigational Site

    Varna, 9010

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About this study

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

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.

Read the 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.

Being tested
Salmeterol 50mcg/ Fluticasone Propionate 500mcg
Keywords
mortality, TORCH, SERETIDE, ADVAIR, COPD
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Salmeterol 50mcg/ Fluticasone Propionate 500mcgDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality at 3 years

Secondary outcomes (1)

  1. Rate of moderate and severe COPD exacerbations and health status assessed by the St. George's Respiratory Questionnaire.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2005 (estimated)
  2. Study startSep 2000
  3. Primary completionNov 2005
  4. Study completionNov 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
6,228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00268216
Sponsor's protocol ID
SCO30003
Status last verified
Jan 2017
First submitted
20 Dec 2005
Last updated
20 Jan 2017
Results posted
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 19717476

  • 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.

    PubMed 17314337

  • 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.

    PubMed 18511702

  • 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.

    PubMed 19566934

  • 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.

    PubMed 19443528

  • 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.

    PubMed 18510885

  • 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.

    PubMed 19581353

  • 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.

    PubMed 18280761

  • 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.

    PubMed 17629923

  • 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.

    PubMed 19353351

  • 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.

    PubMed 19880616

  • 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.

    PubMed 20486816

  • 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.

    PubMed 19234322

  • 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.

    PubMed 17311843

  • 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.

    PubMed 18565964

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Salmeterol 50mcg/ Fluticasone Propionate 500mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 459 sites in 45 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 459 sites in United States, France, Canada, Spain, Norway and 39 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause mortality at 3 years. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00268216, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.

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