Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: Salmeterol/fluticasone propionate 50/500mcg Diskus (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
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
Clinical Details
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)
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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: 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
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Aalborg DK-9100, Denmark
GSK Clinical Trials Call Center, Copenhagen DK-2400, Denmark
GSK Clinical Trials Call Center, Tartu 51014 Tartu, Estonia
GSK Clinical Trials Call Center, Tallinn 13419 Tallinn, Estonia
GSK Clinical Trials Call Center, Helsinki FIN-00029 HUS, Finland
GSK Clinical Trials Call Center, Palermo 90146 Palermo, Italy
GSK Clinical Trials Call Center, Kaunas LT-3000, Lithuania
GSK Clinical Trials Call Center, Kaunas LT-3007, Lithuania
GSK Clinical Trials Call Center, Vilnius LT-2021, Lithuania
GSK Clinical Trials Call Center, Bratislava 825 56 Bratislava, Slovakia
GSK Clinical Trials Call Center, Madrid 28046 Madrid, Spain
GSK Clinical Trials Call Center, Caceres 10003 Caceres, Spain
GSK Clinical Trials Call Center, London E2 9JX, United Kingdom
GSK Clinical Trials Call Center, Nottingham NG7 2UH, United Kingdom
GSK Clinical Trials Call Center, Norwich NR4 7UY, United Kingdom
GSK Clinical Trials Call Center, Nottingham NG5 1PB, United Kingdom
GSK Clinical Trials Call Center, Leicester LE3 9QP, United Kingdom
GSK Clinical Trials Call Center, Cottingham HU16 5JD, United Kingdom
Additional Information
Starting date: September 2002
Last updated: December 21, 2005
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