Clinical trial NCT00268177: Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Airways
Pulmonary
Obstructive
Chronic
inflammation
salmeterol/fluticasone propionate
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-12-22
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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.

Primary outcomes:
measure: 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 outcomes:
measure: 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
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: GSK Investigational Site
city: Kobenhavn NV
country: Denmark
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Palermo
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Kosice
country: Slovakia
facility: GSK Investigational Site
city: Caceres
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Leicester
country: United Kingdom
facility: GSK Investigational Site
state: Leicestershire
city: Norwich
country: United Kingdom
facility: GSK Investigational Site
state: Norfolk
city: Nottingham
country: United Kingdom
facility: GSK Investigational Site
state: Nottinghamshire
city: Nottingham
country: United Kingdom
facility: GSK Investigational Site
state: Nottinghamshire
city: Hull
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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. doi: 10.1164/rccm.200508-1321OC. Epub 2006 Jan 19.
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
citation: 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.
citation: 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.
citation: 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.
citation: 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. doi: 10.1183/09031936.04.00120603.
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