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OpenTrials
Completed

NCT Number: NCT00549146

Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Alkmaar, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fluticasone propionate/salmeterol 250/50 DISKUS combination product

Drug

fluticasone propionate DISKUS 500mcg

Drug

Other names: fluticasone propionate/salmeterol 250/50 DISKUS combination product

Primary outcomes

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

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Oct 25, 2007
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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