Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Multi-centre, DB, R and Stratified Parallel Group Study to Compare the Efficacy and Safety of FP 500mcg Bid vs. SRT 50/250mcg Via Diskus in COPD Pts With Partial Reversible Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549146
• Other study ID #: SCO40055
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2007
• Last updated: January 19, 2017
• Start date: November 2003
• Est. completion date: April 2006

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• fluticasone propionate/salmeterol 250/50 DISKUS combination product

• fluticasone propionate DISKUS 500mcg

Locations

Country	Name	City	State
Netherlands	GSK Investigational Site	Alkmaar
Netherlands	GSK Investigational Site	Almelo
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Drachten
Netherlands	GSK Investigational Site	Haarlem
Netherlands	GSK Investigational Site	Harderwijk
Netherlands	GSK Investigational Site	Hengelo
Netherlands	GSK Investigational Site	Hoorn
Netherlands	GSK Investigational Site	Leeuwarden
Netherlands	GSK Investigational Site	Meppel
Netherlands	GSK Investigational Site	Nijmegen
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Sneek
Netherlands	GSK Investigational Site	Utrecht
Netherlands	GSK Investigational Site	Voerendaal

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in efficacy of a 12 months treatment with salmeterol/fluticasone combination versus fluticasone on lung function (FEV1) as percentage predicted.
Secondary	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).