Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease

September 13, 2016 updated by: GlaxoSmithKline

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

130

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, DK-9100
        • GSK Investigational Site
      • Kobenhavn NV, Denmark, 2400
        • GSK Investigational Site
  • Estonia
      • Tallinn, Estonia, 13419
        • GSK Investigational Site
      • Tartu, Estonia, 51014
        • GSK Investigational Site
  • Finland
      • Helsinki, Finland, 00029
        • GSK Investigational Site
  • Italy
    • Sicilia
      • Palermo, Sicilia, Italy, 90146
        • GSK Investigational Site
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • GSK Investigational Site
      • Kaunas, Lithuania, LT-44320
        • GSK Investigational Site
      • Vilnius, Lithuania, LT-08661
        • GSK Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 825 56
        • GSK Investigational Site
      • Kosice, Slovakia, 041 90
        • GSK Investigational Site
  • Spain
      • Caceres, Spain, 10003
        • GSK Investigational Site
      • Madrid, Spain, 28047
        • GSK Investigational Site
  • United Kingdom
      • Hull, United Kingdom, HU16 5JQ
        • GSK Investigational Site
      • London, United Kingdom, E7 8QP
        • GSK Investigational Site
      • London, United Kingdom, E2 9JX
        • GSK Investigational Site
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE3 9QP
        • GSK Investigational Site
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UZ
        • GSK Investigational Site
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • GSK Investigational Site
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

December 20, 2005

First Submitted That Met QC Criteria

December 21, 2005

First Posted (Estimate)

December 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCO30005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: SCO30005
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: SCO30005
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistical Analysis Plan
    Information identifier: SCO30005
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: SCO30005
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: SCO30005
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annotated Case Report Form
    Information identifier: SCO30005
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Dataset Specification
    Information identifier: SCO30005
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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