Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00268177
First received: December 20, 2005
Last updated: April 11, 2013
Last verified: February 2011
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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 |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: Salmeterol/fluticasone propionate 50/500mcg Diskus |
Phase 3 |
| 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:
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:
-
Drug: Salmeterol/fluticasone propionate 50/500mcg Diskus
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
| 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 | |
| United Kingdom | |
| GSK Investigational Site | |
| Norwich, Norfolk, United Kingdom, NR4 7UZ | |
| GSK Investigational Site | |
| Nottingham, Nottinghamshire, United Kingdom, NG7 2UH | |
| GSK Investigational Site | |
| London, United Kingdom, E2 9JX | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Publications:
Barnes NC, Qiu Y, Zhu J, et al. Anti-inflammatory effects of salmeterol/fluticasone propionate (SFC) by smoking status in COPD. Eur Respir J 2005; 26(suppl 49): 204S.
Qiu Y, Davis P, Zhu J, et al. Anti-inflammatory effects of salmeterol/fluticasone propionate (SFC) on airway T-lymphocyte populations in COPD. Eur Respir J 2005; 26(suppl 49): 203S.
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00268177 History of Changes |
| Other Study ID Numbers: | SCO30005 |
| Study First Received: | December 20, 2005 |
| Last Updated: | April 11, 2013 |
| Health Authority: | Slovakia: State Institute for Drug Control Finland: Finnish Medicines Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency Spain: Spanish Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Estonia: The State Agency of Medicine Italy: The Italian Medicines Agency Denmark: Danish Medicines Agency |
Keywords provided by GlaxoSmithKline:
|
Airways Pulmonary Obstructive |
Chronic inflammation salmeterol/fluticasone propionate |
Additional relevant MeSH terms:
|
Chronic Disease Inflammation Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Disease Attributes 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 May 22, 2013