Chronic Obstructive Pulmonary Disease Endpoints Study

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358358
• Other study ID #: SCO104925
• Status: Completed
• Phase: Phase 4
• First received: July 27, 2006
• Last updated: January 19, 2017
• Start date: March 2006
• Est. completion date: February 2007

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Fluticasone Propionate/Salmeterol 500/50mcg combination

• Fluticasone Propionate 500mcg

• Salmeterol 50mcg

Locations

Country	Name	City	State
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Valparaiso	Valparaíso
Estonia	GSK Investigational Site	Tartu
Russian Federation	GSK Investigational Site	Barnaul
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Nizhnekamsk
United States	GSK Investigational Site	Absecon	New Jersey
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Chile,  Estonia,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral airway resistance measured by IOS
Secondary	Airway wall thickness measured by CT scans

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.