Clinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)

April 11, 2013 updated by: GlaxoSmithKline

See Detailed Description

This study compares the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 18 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Clinical Evaluation of GW815SF for Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) "Assessment of the Effect of Addition of Fluticasone Dipropionate to Salmeterol Xinafoate 50µg after Switching under Double-blinded conditions to GW815SF 50/250µg in Chronic Obstructive Pulmonary Disease

Study Type

Interventional

Enrollment (Actual)

150

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

        • GSK Investigational Site
  • Japan
      • Kyoto, Japan, 602-8026
        • 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:

  • Diagnosis of COPD.

Exclusion criteria:

  • Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD.
  • 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: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in pre-dose FEV1 at 4 weeks after starting medication of GW815SF 50/250µg

Secondary Outcome Measures

Outcome Measure
Change in morning PEF
Changes in pre-dose FVC, V50, V25
Use of rescue medication
Changes in symptom scores

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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

February 1, 2005

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

December 21, 2005

First Submitted That Met QC Criteria

December 21, 2005

First Posted (Estimate)

December 23, 2005

Study Record Updates

Last Update Posted (Estimate)

April 15, 2013

Last Update Submitted That Met QC Criteria

April 11, 2013

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCO100646

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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