Skip to main content
OpenTrials
Completed

NCT Number: NCT00358358

Chronic Obstructive Pulmonary Disease Endpoints Study

This study will last for approximately 14 weeks and will involve 5 visits. The study is being carried out to look at different ways of measuring the effect of drug treatment on COPD. COPD is a respiratory disease which can affect your breathing and daily life. Symptoms of COPD can include breathlessness, cough, and wheeze. COPD varies enormously from patient to patient. The effects of drug treatment are usually measured by conducting lung function tests (breathing tests) using a machine called a spirometer but this does not always provide a complete picture of how well your COPD is responding. In this study we therefore want to look at new and more sensitive ways of measuring COPD. The results of this research will help in the assessment of new drugs for COPD in the future.

Completed

Looking for future studies?

Notify Me

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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Santiago, Región Metro de Santiago, Chile

Loading trial locations.

About this study

Evaluation of Novel Endpoints in Subjects with Chronic Obstructive Pulmonary Disease (COPD) in a Randomized, Double-Blind, Placebo-Controlled Study of Treatment with Fluticasone Propionate/Salmeterol 500/50mcg combination (FSC 500/50) and its individual components, Fluticasone Propionate 500mcg (FP500) and Salmeterol 50mcg (SAL 50)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of COPD
  • Current or ex-smoker at least 10 pack- years

Exclusion criteria

  • Diagnosis of asthma
  • Active respiratory disorder other than COPD
  • Evidence of clinically significant uncontrolled non-pulmonary disease
  • Carcinoma not in complete remission for last 5 years
  • Lung volume reduction surgery in previous 12 months
  • Nocturnal positive pressure for sleep apnea
  • Other inclusion and exclusion criteria will be evaluated at the first study visit.

Treatment and study plan

Fluticasone Propionate/Salmeterol 500/50mcg combination

Drug

Fluticasone Propionate 500mcg

Drug

Salmeterol 50mcg

Drug

Other names: Fluticasone Propionate/Salmeterol 500/50mcg combination, Fluticasone Propionate 500mcg

Primary outcomes

  1. Peripheral airway resistance measured by IOS

Secondary outcomes

  1. Airway wall thickness measured by CT scans

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Randomized, Double-blind Placebo-controlled Study of Treatments With Salmeterol, Fluticasone Propionate and Their Combination to Evaluate Novel Endpoints in Patients With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 31, 2006
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.