Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2003-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Salmeterol/fluticasone propionate 50/500mcg Diskus

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Aalborg, , Denmark

Site Status

GSK Investigational Site

København NV, , Denmark

Site Status

GSK Investigational Site

Tallinn, , Estonia

Site Status

GSK Investigational Site

Tartu, , Estonia

Site Status

GSK Investigational Site

Helsinki, , Finland

Site Status

GSK Investigational Site

Palermo, Sicily, Italy

Site Status

GSK Investigational Site

Kaunas, , Lithuania

Site Status

GSK Investigational Site

Kaunas, , Lithuania

Site Status

GSK Investigational Site

Vilnius, , Lithuania

Site Status

GSK Investigational Site

Bratislava, , Slovakia

Site Status

GSK Investigational Site

Košice, , Slovakia

Site Status

GSK Investigational Site

Cáceres, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Leicester, Leicestershire, United Kingdom

Site Status

GSK Investigational Site

Norwich, Norfolk, United Kingdom

Site Status

GSK Investigational Site

Nottingham, Nottinghamshire, United Kingdom

Site Status

GSK Investigational Site

Nottingham, Nottinghamshire, United Kingdom

Site Status

GSK Investigational Site

Hull, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

Countries

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Denmark Estonia Finland Italy Lithuania Slovakia Spain United Kingdom

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

PMID: 16424444 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

PMID: 15332386 (View on PubMed)

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

Reference Type BACKGROUND

Study Documents

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