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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
History of Changes

October 24, 2007
April 11, 2013
November 2003
Not Provided
Difference in efficacy of a 12 months treatment with salmeterol/fluticasone combination versus fluticasone on lung function (FEV1) as percentage predicted.
Difference in efficacy of a 12 months treatment with salmeterol/fluticasone combination versus fluticasone on lungfunction (FEV1) as percentage predicted.
Complete list of historical versions of study NCT00549146 on ClinicalTrials.gov Archive Site
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).
Reversibility of lungfunction 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).
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Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease
See Detailed Description

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • 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
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
290
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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.
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00549146
SCO40055
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP