Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease
This study was designed to look at effects of salmeterol/fluticasone propionate compared to placebo on airway inflammation in patients with chronic obstructive airways...
Brief Summary
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)”
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
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Salmeterol/fluticasone propionate 50/500mcg Diskus
Outcome Measures for this Clinical Trial
Primary 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 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
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: GlaxoSmithKline Industry
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00268177
Study ID Number: SCO30005
ClinicalTrials.gov Identifier: NCT00268177
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00268177
