Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: fluticasone propionate/salmeterol 250/50 DISKUS combination product (Drug); fluticasone propionate DISKUS 500mcg (Drug)
Phase: Phase 4
Sponsored by: GlaxoSmithKline
Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Official title: 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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Difference in efficacy of a 12 months treatment with salmeterol/fluticasone combination versus fluticasone on lung function (FEV1) as percentage predicted.
Secondary outcome: 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).
Minimum age: 40 Years.
Maximum age: 80 Years.
- 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
- Signed and dated informed consent.
- 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.
Locations and Contacts
GSK Clinical Trials Call Center, Groningen 9728 NZ, Netherlands
GSK Clinical Trials Call Center, Dordrecht 3317 NM, Netherlands
GSK Clinical Trials Call Center, Sneek 8601 ZK, Netherlands
GSK Clinical Trials Call Center, Amsterdam 1034 CS, Netherlands
GSK Clinical Trials Call Center, Eindhoven 5623 EJ, Netherlands
GSK Clinical Trials Call Center, Meppel 7943 KA, Netherlands
GSK Clinical Trials Call Center, Helmond 5707 HA, Netherlands
GSK Clinical Trials Call Center, Ede 6717 RP, Netherlands
GSK Clinical Trials Call Center, Woerden 3447 GN, Netherlands
Starting date: October 2003
Last updated: January 15, 2008