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OpenTrials
Completed

NCT Number: NCT00268216

Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salmeterol 50mcg/ Fluticasone Propionate 500mcg

Drug

Primary outcomes

  1. All cause mortality at 3 years

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2005
Study completion
2005
First posted
Dec 22, 2005
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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