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Chronic Obstructive Pulmonary Disease Endpoints Study
This study has been completed.
Study NCT00358358   Information provided by GlaxoSmithKline
First Received: July 27, 2006   Last Updated: May 15, 2009   History of Changes

July 27, 2006
May 15, 2009
March 2006
 
Peripheral airway resistance measured by IOS
Same as current
Complete list of historical versions of study NCT00358358 on ClinicalTrials.gov Archive Site
Airway wall thickness measured by CT scans
Same as current
 
Chronic Obstructive Pulmonary Disease Endpoints Study
See Detailed Description

This study will last for approximately 14 weeks and will involve 5 visits. The study is being carried out to look at different ways of measuring the effect of drug treatment on COPD. COPD is a respiratory disease which can affect your breathing and daily life. Symptoms of COPD can include breathlessness, cough, and wheeze. COPD varies enormously from patient to patient. The effects of drug treatment are usually measured by conducting lung function tests (breathing tests) using a machine called a spirometer but this does not always provide a complete picture of how well your COPD is responding. In this study we therefore want to look at new and more sensitive ways of measuring COPD. The results of this research will help in the assessment of new drugs for COPD in the future.

Evaluation of Novel Endpoints in Subjects with Chronic Obstructive Pulmonary Disease (COPD) in a Randomized, Double-Blind, Placebo-Controlled Study of Treatment with Fluticasone Propionate/Salmeterol 500/50mcg combination (FSC 500/50) and its individual components, Fluticasone Propionate 500mcg (FP500) and Salmeterol 50mcg (SAL 50)

Phase IV
Interventional
Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Chronic Obstructive Pulmonary Disease (COPD)
  • Drug: Fluticasone Propionate/Salmeterol 500/50mcg combination
  • Drug: Fluticasone Propionate 500mcg
  • Drug: Salmeterol 50mcg
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
140
 
 

Inclusion criteria:

  • Diagnosis of COPD
  • Current or ex-smoker at least 10 pack- years

Exclusion criteria:

  • Diagnosis of asthma
  • Active respiratory disorder other than COPD
  • Evidence of clinically significant uncontrolled non-pulmonary disease
  • Carcinoma not in complete remission for last 5 years
  • Lung volume reduction surgery in previous 12 months
  • Nocturnal positive pressure for sleep apnea
  • Other inclusion and exclusion criteria will be evaluated at the first study visit.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Chile,   Estonia,   Russian Federation
 
NCT00358358
Study Director, GSK
SCO104925
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
May 2009

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