Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: December 20, 2005
Last updated: April 15, 2015
Last verified: April 2015
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:

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.

Enrollment: 6228
Study Start Date: September 2000
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00268216

United States, California
GSK Investigational Site
San Francisco, California, United States, 94102
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19129
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, 20 551-030
GSK Investigational Site
Rio de Janeiro, Brazil, 20221-903
GSK Investigational Site
Rio de Janeiro, Brazil, 21941-590
GSK Investigational Site
São Paulo, Brazil, 05403-900
GSK Investigational Site
Maurepas, France, 78310
GSK Investigational Site
Meaux, France, 77104
GSK Investigational Site
Papagos/Athens, Greece, 15669
GSK Investigational Site
Zwolle, Netherlands, 8025 AB
GSK Investigational Site
Partizanske, Slovakia, 958 01
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
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Salmeterol plus fluticasone fails to reduce mortality in patients with COPD. Formulary 2007;42:245-6.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GlaxoSmithKline Identifier: NCT00268216     History of Changes
Other Study ID Numbers: SCO30003 
Study First Received: December 20, 2005
Last Updated: April 15, 2015
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:

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 25, 2016