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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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)

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:

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

Intervention Details:

Other Name: Salmeterol/fluticasone propionate 50/500mcg Diskus

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
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
Caceres, Spain, 10003
GSK Investigational Site
Madrid, Spain, 28047
United Kingdom
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE3 9QP
GSK Investigational Site
Norwich, Norfolk, United Kingdom, NR4 7UZ
GSK Investigational Site
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
GSK Investigational Site
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
GSK Investigational Site
Hull, United Kingdom, HU16 5JQ
GSK Investigational Site
London, United Kingdom, E7 8QP
GSK Investigational Site
London, United Kingdom, E2 9JX

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00268177 History of Changes
Other Study ID Numbers:	SCO30005
Study First Received:	December 20, 2005
Last Updated:	December 4, 2008
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Denmark: Danish Medicines Agency; Estonia: The State Agency of Medicine; Finland: Finnish Medicines Agency; 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

Additional relevant MeSH terms:

Inflammation
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Salmeterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012