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

Tracking Information

First Received Date ^ICMJE

December 21, 2005

Last Updated Date

October 15, 2008

Start Date ^ICMJE

February 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00269126 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

See Detailed Description

Brief Summary

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.

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease (COPD)

Intervention ^ICMJE

Drug: fluticasone propionate/salmeterol combination DISKUS
Drug: salmeterol xinafoate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

150

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00269126

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

SCO100646

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP