Chronic Obstructive Pulmonary Disease Endpoints Study - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00358358

Purpose

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.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: Fluticasone Propionate/Salmeterol 500/50mcg combination Drug: Fluticasone Propionate 500mcg Drug: Salmeterol 50mcg	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Peripheral airway resistance measured by IOS

Secondary Outcome Measures:

Airway wall thickness measured by CT scans

Estimated Enrollment:	140
Study Start Date:	March 2006

Detailed 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)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358358

Locations

United States, New Jersey
GSK Investigational Site
Absecon, New Jersey, United States, 8201
United States, South Carolina
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Chile, Región Metro De Santiago
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500691
Chile, Valparaíso
GSK Investigational Site
Valparaiso, Valparaíso, Chile, 2352499
Estonia
GSK Investigational Site
Tartu, Estonia, 51014
Russian Federation
GSK Investigational Site
Barnaul, Russian Federation, 656 045
GSK Investigational Site
Moscow, Russian Federation, 105 229
GSK Investigational Site
Moscow, Russian Federation, 105 077

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SCO104925
Study First Received:	July 27, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00358358 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

COPD
Impulse Oscillometry System
Computerized Tomography

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Salmeterol
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Respiration Disorders
Anti-Asthmatic Agents
Anti-Allergic Agents
Adrenergic Agonists

Pharmacologic Actions
Lung Diseases, Obstructive
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 08, 2010