NCT00268177

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_3

Geographic Reach
7 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

First QC Date

December 20, 2005

Last Update Submit

September 13, 2016

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

AirwaysPulmonaryObstructiveChronicinflammationsalmeterol/fluticasone propionate

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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

Interventions

Salmeterol/fluticasone propionate 50/500mcg DiskusDRUG

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Diagnosis of any other serious disease and must have a chest X-ray to eliminate a diagnosis other than COPD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

GSK Investigational Site

Aalborg, DK-9100, Denmark

Location

GSK Investigational Site

København NV, 2400, Denmark

Location

GSK Investigational Site

Tallinn, 13419, Estonia

Location

GSK Investigational Site

Tartu, 51014, Estonia

Location

GSK Investigational Site

Helsinki, 00029, Finland

Location

GSK Investigational Site

Palermo, Sicily, 90146, Italy

Location

GSK Investigational Site

Kaunas, LT-44320, Lithuania

Location

GSK Investigational Site

Kaunas, LT-50009, Lithuania

Location

GSK Investigational Site

Vilnius, LT-08661, Lithuania

Location

GSK Investigational Site

Bratislava, 825 56, Slovakia

Location

GSK Investigational Site

Košice, 041 90, Slovakia

Location

GSK Investigational Site

Cáceres, 10003, Spain

Location

GSK Investigational Site

Madrid, 28047, Spain

Location

GSK Investigational Site

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

GSK Investigational Site

Norwich, Norfolk, NR4 7UZ, United Kingdom

Location

GSK Investigational Site

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

GSK Investigational Site

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

GSK Investigational Site

Hull, HU16 5JQ, United Kingdom

Location

GSK Investigational Site

London, E2 9JX, United Kingdom

Location

GSK Investigational Site

London, E7 8QP, United Kingdom

Location

Related 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.

    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.

    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.

    PMID: 16424444BACKGROUND

  • 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

    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.

    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.

    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.

    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.

    PMID: 15332386BACKGROUND

  • 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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBronchiolitis Obliterans SyndromeInflammation

Interventions

Salmeterol XinafoateFluticasone

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

AlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesAndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 22, 2005

Study Start

October 1, 2002

Study Completion

December 1, 2003

Last Updated

September 15, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Available IPD Datasets

Individual Participant Data Set (SCO30005)Access
Study Protocol (SCO30005)Access
Statistical Analysis Plan (SCO30005)Access
Informed Consent Form (SCO30005)Access
Clinical Study Report (SCO30005)Access
Annotated Case Report Form (SCO30005)Access
Dataset Specification (SCO30005)Access

Locations

ES(2)LI(3)DK(2)IT(1)FI(1)SL(2)GB(7)