Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

October 24, 2007

Last Updated Date

May 15, 2009

Start Date ^ICMJE

November 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Difference in efficacy of a 12 months treatment with salmeterol/fluticasone combination versus fluticasone on lung function (FEV1) as percentage predicted.

Original Primary Outcome Measures ^ICMJE

Difference in efficacy of a 12 months treatment with salmeterol/fluticasone combination versus fluticasone on lungfunction (FEV1) as percentage predicted.

Change History

Complete list of historical versions of study NCT00549146 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Reversibility of lung function with salbutamol and on Forced Vital capacity (FVC), TLC, FRC, FVC, Inspiration capacity(IC), Forced Inspiratory Volume in 1 second (FIV1) and Maximum mid-Expiratory Flow (MEF50).

Original Secondary Outcome Measures ^ICMJE

Reversibility of lungfunction with salbutamol and on Forced Vital capacity (FVC), TLC, FRC, FVC, Inspiration capacity(IC), Forced Inspiratory Volume in 1 second (FIV1) and Maximum mid-Expiratory Flow (MEF50).

Descriptive Information

Brief Title ^ICMJE

Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease

Official Title ^ICMJE

See Detailed Description

Brief Summary

Relatively little information is available about the effects of salmeterol/fluticasone combination and fluticasone alone in COPD patients with a partial reversible pulmonary obstruction. The purpose of this study is to compare the effects of salmeterol/fluticasone combination with fluticasone alone delivered via Diskus/ACCUHALER inhaler in subjects with COPD on lung function over a 1 year period.

Detailed Description

Multi-centre, double-blind, randomised and stratified parallel group study to compare the efficacy and safety of fluticasone propionate 500 mcg bd versus salmeterol/fluticasone combination 50/250 mcg bd both via Diskus inhaler during 1 year in Chronic Obstructive Pulmonary Disease(COPD) patients with a partially reversible obstruction.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease (COPD)

Intervention ^ICMJE

Drug: fluticasone propionate/salmeterol 250/50 DISKUS combination product
Drug: fluticasone propionate DISKUS 500mcg

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

290

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion criteria:

Established history of chronic obstructive pulmonary disease (COPD).
Lung function parameters: FEV1/FVC ratio < 70%, FEV1 between 80% and 30% predicted, a reversibility of airway obstruction of 12% of the initial value with a minimum of 200 mL.
Signed and dated informed consent.

Exclusion criteria:

History of asthma or allergy.
Unstable COPD in the 3 months before the study.
Interference of non-pulmonary medication or diseases with COPD outcome parameters.

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

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00549146

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

SCO40055, SER 0302 / SICLONE

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

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