Chronic Obstructive Pulmonary Disease Endpoints Study

January 19, 2017 updated by: GlaxoSmithKline

A Randomized, Double-blind Placebo-controlled Study of Treatments With Salmeterol, Fluticasone Propionate and Their Combination to Evaluate Novel Endpoints in Patients With Chronic Obstructive Pulmonary Disease

This study will last for approximately 14 weeks and will involve 5 visits. The study is being carried out to look at different ways of measuring the effect of drug treatment on COPD. COPD is a respiratory disease which can affect your breathing and daily life. Symptoms of COPD can include breathlessness, cough, and wheeze. COPD varies enormously from patient to patient. The effects of drug treatment are usually measured by conducting lung function tests (breathing tests) using a machine called a spirometer but this does not always provide a complete picture of how well your COPD is responding. In this study we therefore want to look at new and more sensitive ways of measuring COPD. The results of this research will help in the assessment of new drugs for COPD in the future.

Study Overview

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Intervention / Treatment

Detailed Description

Evaluation of Novel Endpoints in Subjects with Chronic Obstructive Pulmonary Disease (COPD) in a Randomized, Double-Blind, Placebo-Controlled Study of Treatment with Fluticasone Propionate/Salmeterol 500/50mcg combination (FSC 500/50) and its individual components, Fluticasone Propionate 500mcg (FP500) and Salmeterol 50mcg (SAL 50)

Study Type

Interventional

Enrollment (Actual)

163

Phase

Phase 4

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

Chile
- Región Metro De Santiago
  - Santiago, Región Metro De Santiago, Chile, 7500691
    - GSK Investigational Site
- Valparaíso
  - Valparaiso, Valparaíso, Chile, 2341131
    - GSK Investigational Site
Estonia
- - Tartu, Estonia, 51014
    - GSK Investigational Site
Russian Federation
- - Barnaul, Russian Federation, 656 045
    - GSK Investigational Site
  - Moscow, Russian Federation, 105 229
    - GSK Investigational Site
  - Moscow, Russian Federation, 105 077
    - GSK Investigational Site
  - Nizhnekamsk, Russian Federation, 423570
    - GSK Investigational Site
United States
- New Jersey
  - Absecon, New Jersey, United States, 8201
    - GSK Investigational Site
- South Carolina
  - Charleston, South Carolina, United States, 29406-7108
    - GSK Investigational Site
  - Greenville, South Carolina, United States, 29615
    - GSK Investigational Site
  - Spartanburg, South Carolina, United States, 29303
    - 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion criteria:

Diagnosis of COPD
Current or ex-smoker at least 10 pack- years

Exclusion criteria:

Diagnosis of asthma
Active respiratory disorder other than COPD
Evidence of clinically significant uncontrolled non-pulmonary disease
Carcinoma not in complete remission for last 5 years
Lung volume reduction surgery in previous 12 months
Nocturnal positive pressure for sleep apnea
Other inclusion and exclusion criteria will be evaluated at the first study visit.

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
Peripheral airway resistance measured by IOS

Secondary Outcome Measures

Outcome Measure
Airway wall thickness measured by CT scans

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

Kreindler JL, Watkins ML, Lettis S, Tal-Singer R, Locantore N. Effect of inhaled corticosteroids on blood eosinophil count in steroid-naive patients with COPD. BMJ Open Respir Res. 2016 Sep 8;3(1):e000151. doi: 10.1136/bmjresp-2016-000151. eCollection 2016.

Helpful Links

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

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

March 1, 2006

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

July 27, 2006

First Submitted That Met QC Criteria

July 27, 2006

First Posted (Estimate)

July 31, 2006

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

SCO104925

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

Clinical Study Report
Information identifier: SCO104925

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: SCO104925

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set
Information identifier: SCO104925

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: SCO104925

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: SCO104925

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: SCO104925

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Information identifier: SCO104925

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.