Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00549146
First received: October 24, 2007
Last updated: April 11, 2013
Last verified: February 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • 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).

Estimated Enrollment: 290
Study Start Date: November 2003
Intervention Details:
    Drug: fluticasone propionate/salmeterol 250/50 DISKUS combination product Drug: fluticasone propionate DISKUS 500mcg
    Other Names:
    • fluticasone propionate DISKUS 500mcg
    • fluticasone propionate/salmeterol 250/50 DISKUS combination product
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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549146

Locations
Netherlands
GSK Investigational Site
Alkmaar, Netherlands, 1815 JD
GSK Investigational Site
Almelo, Netherlands, 7609 PP
GSK Investigational Site
Amsterdam, Netherlands, 1091 AC
GSK Investigational Site
Amsterdam, Netherlands, 1034 CS
GSK Investigational Site
Amsterdam, Netherlands, 1058 NR
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00549146     History of Changes
Other Study ID Numbers: SCO40055
Study First Received: October 24, 2007
Last Updated: April 11, 2013
Health Authority: Netherlands: Centrale Commissie Mensgebonden Onderzoek

Keywords provided by GlaxoSmithKline:
reversibility
COPD
lung function

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Salmeterol
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 28, 2014