Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00268177

Purpose

This study was designed to look at effects of salmeterol/fluticasone propionate compared to placebo on airway inflammation in patients with chronic obstructive airways disease

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: Salmeterol/fluticasone propionate 50/500mcg Diskus	Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Fluticasone Fluticasone propionate Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	A 13-Week, Double-Blind, Parallel Group, Multi-Centre Study to Compare the Bronchial Anti-Inflammatory Activity of the Combination of Salmeterol/Fluticasone Propionate 50/500mcg Twice Daily Compared With Placebo Twice Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

To compare the number of CD68+ and CD8+ inflammatory cells per area of biopsy tissue and the percentage and total number of neutrophils in induced sputum between salmeterol/fluticasone propionate and placebo

Secondary Outcome Measures:

To compare the number of mast cells, CD45+,CD4+,IFN-gamma mRNA+,TNF-alpha mRNA+, per area of biopsy and the percentage and number of macrophages, eosinophils, lymphocytes in induced sputum between salmeterol/fluticasone propionate and placebo

Estimated Enrollment:	130
Study Start Date:	October 2002

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Established clinical history of chronic obstructive airways disease.
Must be current or ex-smokers with a smoking history of at least 10 pack-years (e.g. 20 cigarettes/day for 10 years or 10 cigarettes/day for 20 years).
Must have reduced lung function, defined as a Forced Expiratory Volume in 1 second (FEV1) of between 40-80% of predicted normal values.

Exclusion Criteria:

Diagnosis of any other serious disease and must have a chest X-ray to eliminate a diagnosis other than COPD.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268177

Locations

Denmark
GSK Investigational Site
Aalborg, Denmark, DK-9100
GSK Investigational Site
Kobenhavn NV, Denmark, 2400
Estonia
GSK Investigational Site
Tallinn, Estonia, 13419
GSK Investigational Site
Tartu, Estonia, 51014
Finland
GSK Investigational Site
Helsinki, Finland, 00029
Italy, Sicilia
GSK Investigational Site
Palermo, Sicilia, Italy, 90146
Lithuania
GSK Investigational Site
Kaunas, Lithuania, LT-44320
GSK Investigational Site
Kaunas, Lithuania, LT-50009
GSK Investigational Site
Vilnius, Lithuania, LT-08661
Slovakia
GSK Investigational Site
Bratislava, Slovakia, 825 56
GSK Investigational Site
Kosice, Slovakia, 041 90
Spain
GSK Investigational Site
Madrid, Spain, 28047
GSK Investigational Site
Caceres, Spain, 10003
United Kingdom
GSK Investigational Site
London, United Kingdom, E7 8QP
GSK Investigational Site
London, United Kingdom, E2 9JX
GSK Investigational Site
Hull, United Kingdom, HU16 5JQ
United Kingdom, Leicestershire
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE3 9QP
United Kingdom, Norfolk
GSK Investigational Site
Norwich, Norfolk, United Kingdom, NR4 7UZ
United Kingdom, Nottinghamshire
GSK Investigational Site
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
GSK Investigational Site
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SCO30005
Study First Received:	December 20, 2005
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00268177
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Denmark: Danish Medicines Agency; Estonia: The State Agency of Medicine; Finland: National Agency for Medicines; Italy: The Italian Medicines Agency; Lithuania: State Medicine Control Agency - Ministry of Health; Slovakia: State Institute for Drug Control; Spain: Spanish Agency of Medicines

Keywords provided by GlaxoSmithKline:

Chronic
Obstructive
Pulmonary

Airways
salmeterol/fluticasone propionate
inflammation

Study placed in the following topic categories:

Lung Diseases, Obstructive
Salmeterol
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Fluticasone
Inflammation
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

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

Anti-Allergic Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 15, 2009