Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268177
• Other study ID #: SCO30005
• Status: Completed
• Phase: Phase 3
• First received: December 20, 2005
• Last updated: September 13, 2016
• Start date: October 2002
• Est. completion date: December 2003

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: State Institute for Drug ControlFinland: Finnish Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySpain: Spanish Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthEstonia: The State Agency of MedicineItaly: The Italian Medicines AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Salmeterol/fluticasone propionate 50/500mcg Diskus

Locations

Country	Name	City	State
Denmark	GSK Investigational Site	Aalborg
Denmark	GSK Investigational Site	Kobenhavn NV
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Finland	GSK Investigational Site	Helsinki
Italy	GSK Investigational Site	Palermo	Sicilia
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Vilnius
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Kosice
Spain	GSK Investigational Site	Caceres
Spain	GSK Investigational Site	Madrid
United Kingdom	GSK Investigational Site	Hull
United Kingdom	GSK Investigational Site	Leicester	Leicestershire
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Norwich	Norfolk
United Kingdom	GSK Investigational Site	Nottingham	Nottinghamshire
United Kingdom	GSK Investigational Site	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Denmark,  Estonia,  Finland,  Italy,  Lithuania,  Slovakia,  Spain,  United Kingdom, 

References & Publications (9)

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.

Barnes NC, Qiu YS, Pavord ID, Parker D, Davis PA, Zhu J, Johnson M, Thomson NC, Jeffery PK; SCO30005 Study Group. Antiinflammatory effects of salmeterol/fluticasone propionate in chronic obstructive lung disease. Am J Respir Crit Care Med. 2006 Apr 1;173(7):736-43. Epub 2006 Jan 19. — View Citation

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.

Vestbo J; TORCH Study Group. The TORCH (towards a revolution in COPD health) survival study protocol. Eur Respir J. 2004 Aug;24(2):206-10. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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