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: April 11, 2013
Last verified: February 2011
  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
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
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 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.
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.
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.
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
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:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Fluticasone
Salmeterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
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 18, 2014