Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease
Phase 3
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00268177
- Lead Sponsor
- GlaxoSmithKline
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
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.
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Exclusion Criteria
- Diagnosis of any other serious disease and must have a chest X-ray to eliminate a diagnosis other than COPD.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧London, United Kingdom