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Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00268177
First received: December 20, 2005
Last updated: September 13, 2016
Last verified: September 2016
  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
Study Completion Date: December 2003
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, NG5 1PB
GSK Investigational Site
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
GSK Investigational Site
Hull, United Kingdom, HU16 5JQ
GSK Investigational Site
London, United Kingdom, E2 9JX
GSK Investigational Site
London, United Kingdom, E7 8QP
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional 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.
Barnes NC, Qiu YS, Pavord I. Clinical improvement with salmeterol/fluticasone proprionate is associated with reduction in inflammation in patients with COPD. European Respiratory Journal Supplement 2005; 26(Suppl. 49): 717 (plus poster) Abstract P4574.
Baseline characteristics of the first 5,000 copd patients enrolled in the torch survival study. Calverley, P. M. A., Celli, B., Ferguson, G., Jenkins, C., Jones, P., Pride, N. B., Vestbo, J., Anderson, J., and Pauwels, R. 13th Annual Congress of the European Respiratory Society 9/27/2003 Vienna; Austria
Pavord I, Parker D, Barnes NC, et al. Effects of salmeterol/fluticasone propionate (SFC) on airway inflammation in induced sputum in COPD. Eur Respir J 2005; 26(suppl 49): 203S.
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.
Qiu Y, Davis P, Zhu J, et al. Effects of salmeterol/fluticasone propionate (SFC) on airway inflammation in COPD: a placebo-controlled study of endobronchial biopsies. Eur Respir J 2005; 26(suppl 49): 203S.
Zhu J, Qiu Y, Barnes NC, Johnson M, Pavord I, Jeffery P. The effect of salmeterol/fluticasone propionate (SFC) on pro-inflammatory gene expression in COPD. PATS 2005; 2(abstracts issue): A127

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SCO30005
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: SCO30005
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: SCO30005
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: SCO30005
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: SCO30005
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: SCO30005
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: SCO30005
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00268177     History of Changes
Other Study ID Numbers: SCO30005 
Study First Received: December 20, 2005
Last Updated: September 13, 2016
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
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Airways
Pulmonary
Obstructive
Chronic
inflammation
salmeterol/fluticasone propionate

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Fluticasone
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016