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Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00268216
First received: December 20, 2005
Last updated: April 11, 2013
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
 Drug: Salmeterol 50mcg/ Fluticasone Propionate 500mcg
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • All cause mortality at 3 years

Secondary Outcome Measures:
  • Rate of moderate and severe COPD exacerbations and health status assessed by the St. George's Respiratory Questionnaire.

Estimated Enrollment: 6040
Study Start Date: September 2000
Intervention Details:
    Drug: Salmeterol 50mcg/ Fluticasone Propionate 500mcg
    Other Name: Salmeterol 50mcg/ Fluticasone Propionate 500mcg
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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268216

Locations
United States, California
GSK Investigational Site
San Francisco, California, United States, 94102
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19129
Brazil
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 40110-160
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035 003
GSK Investigational Site
Santo Andre, São Paulo, Brazil, 09060-670
GSK Investigational Site
Rio de Janeiro, Brazil, 20221-903
GSK Investigational Site
Rio de Janeiro, Brazil, 21941-590
GSK Investigational Site
Rio de Janeiro, Brazil, 20 551-030
GSK Investigational Site
São Paulo, Brazil, 05403-900
France
GSK Investigational Site
Maurepas, France, 78310
GSK Investigational Site
Meaux, France, 77104
Greece
GSK Investigational Site
Papagos/Athens, Greece, 15669
Netherlands
GSK Investigational Site
Zwolle, Netherlands, 8025 AB
Slovakia
GSK Investigational Site
Partizanske, Slovakia, 958 01
Taiwan
GSK Investigational Site
Kaohsiung, Taiwan, 80708
GSK Investigational Site
Taichung, Taiwan, 40705
GSK Investigational Site
Tainan, Taiwan, 704
GSK Investigational Site
Taipei, Taiwan, 112
GSK Investigational Site
Tau-Yuan County, Taiwan, 333
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Peter M.A. Calverley, Julie A. Anderson, Bartolome Celli, Gary T. Ferguson, Christine Jenkins, Paul W. Jones, Courtney Crim, Lisa R. Willits, Julie C. Yates, Jørgen Vestbo. Cardiovascular events in patients with chronic obstructive pulmonary disease: TORCH study results. [Thorax]. 2010;65:719-725.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00268216     History of Changes
Other Study ID Numbers: SCO30003
Study First Received: December 20, 2005
Last Updated: April 11, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
TORCH
COPD
ADVAIR
SERETIDE
mortality

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Salmeterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013