Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 20, 2005

Last Updated Date

February 19, 2009

Start Date ^†

September 2000

Current Primary Outcome Measures ^†

All cause mortality at 3 years

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00268216 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Official Title ^†

See Detailed Description

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Chronic Obstructive Pulmonary Disease (COPD)

Intervention ^†

Drug: Salmeterol 50mcg/ Fluticasone Propionate 500mcg

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

6040

Completion Date

Primary Completion Date

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.

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00268216

Responsible Party

Study Director, GSK

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.