Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00549146
Recruitment Status : Completed
First Posted : October 25, 2007
Last Update Posted : January 20, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: fluticasone propionate/salmeterol 250/50 DISKUS combination product Drug: fluticasone propionate DISKUS 500mcg Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Actual Study Start Date : November 2003
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Intervention Details:
  • Drug: fluticasone propionate/salmeterol 250/50 DISKUS combination product
  • Drug: fluticasone propionate DISKUS 500mcg
    Other Name: fluticasone propionate/salmeterol 250/50 DISKUS combination product

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

Secondary Outcome Measures :
  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).

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00549146

GSK Investigational Site
Alkmaar, Netherlands, 1815 JD
GSK Investigational Site
Almelo, Netherlands, 7609 PP
GSK Investigational Site
Amsterdam, Netherlands, 1034 CS
GSK Investigational Site
Amsterdam, Netherlands, 1058 NR
GSK Investigational Site
Amsterdam, Netherlands, 1091 AC
GSK Investigational Site
Drachten, Netherlands, 9202 NN
GSK Investigational Site
Haarlem, Netherlands, 2012 CE
GSK Investigational Site
Harderwijk, Netherlands, 3844 DG
GSK Investigational Site
Hengelo, Netherlands, 7555 DL
GSK Investigational Site
Hoorn, Netherlands, 1624 NP
GSK Investigational Site
Leeuwarden, Netherlands, 8934 AD
GSK Investigational Site
Meppel, Netherlands, 7943 KA
GSK Investigational Site
Nijmegen, Netherlands, 6532 SZ
GSK Investigational Site
Rotterdam, Netherlands, 3045 PM
GSK Investigational Site
Sneek, Netherlands, 8601 ZK
GSK Investigational Site
Utrecht, Netherlands, 2584 CX
GSK Investigational Site
Voerendaal, Netherlands, 6367 ED
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00549146     History of Changes
Other Study ID Numbers: SCO40055
First Posted: October 25, 2007    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017

Keywords provided by GlaxoSmithKline:
lung function

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists