Chronic Obstructive Pulmonary Disease Endpoints Study
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: Fluticasone Propionate/Salmeterol 500/50mcg combination (Drug); Fluticasone Propionate 500mcg (Drug); Salmeterol 50mcg (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
Official title: 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)
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Peripheral airway resistance measured by IOS
Secondary outcome: Airway wall thickness measured by CT scans
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
GSK Clinical Trials Call Center, Valparaiso, Chile
GSK Clinical Trials Call Center, Santiago, Chile
GSK Clinical Trials Call Center, Tartu 51014, Estonia
GSK Clinical Trials Call Center, Kazan 420015, Russian Federation
GSK Clinical Trials Call Center, Moscow 105229, Russian Federation
GSK Clinical Trials Call Center, Moscow 105077, Russian Federation
GSK Clinical Trials Call Center, Barnaul 656045, Russian Federation
GSK Clinical Trials Call Center, Tucson, Arizona 85724, United States
GSK Clinical Trials Call Center, Absecon, New Jersey 08201, United States
GSK Clinical Trials Call Center, Charleston, South Carolina 29406, United States
GSK Clinical Trials Call Center, Greenville, South Carolina 29615, United States
GSK Clinical Trials Call Center, Spartanburg, South Carolina 29303, United States
Additional Information
Starting date: March 2006
Last updated: April 8, 2008
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