ADVAIR DISKUS (Fluticasone Propionate/Salmeterol) Versus SEREVENT DISKUS (Salmeterol) On Inflammatory Cells And Markers In Chronic Obstructive Pulmonary Disease
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD)
Intervention: Salmeterol (Drug); Fluticasone Propionate/Salmeterol Combination Product (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary
Disease). The study will last 12 weeks. At the end of 12 weeks of treatment, subjects will
stop the study medicines for 2 weeks. The study will involve 6 visits to the clinic.
Subjects who elect to undergo bronchoalveolar lavage (BAL) procedures will have 8 study
visits. Subjects will give sputum, blood, and in some cases BAL samples. Subjects will have
breathing tests and will complete diary cards during the study. All study medicines and
examinations will be given at no cost to the study subjects. Both medicines used in this
study have been approved by the US FDA.
Clinical Details
Official title: A Randomized, Double-Blind, Parallel-Group, 12-Week Study to Evaluate the Anti-Inflammatory Effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg BID Compared With Salmeterol DISKUS 50mcg BID in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Percent of sputum neutrophils
Secondary outcome: Inflammation endpoints: Cell counts in sputum, cell counts and protein markers in BAL, protein markers in blood Clinical endpoints: FEV1 Airway conductance and airway resistance Functional residual capacity Shortness of breath symptoms
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of COPD.
- Pre-bronchodilator FEV1 less than or equal to 70. 0% and greater than or equal to
0. 70L
- Ex-Smokers with at least a 10 pack-year history.
Exclusion Criteria:
- Current of secondary diagnosis of asthma or current diagnosis of atopy.
- Other respiratory disorders other than COPD.
- Other inflammatory diseases.
- Abnormal and clinically significant chest x-ray or ECG.
- Lung resection surgery within past 1 year.
- History of cancer not in remission within past 2 years.
- Serious, uncontrolled disease.
- Pregnancy or planning to become pregnant during the study.
Locations and Contacts
GSK Investigational Site, Birmingham, Alabama 35294, United States
GSK Investigational Site, Los Angeles, California 90095-1752, United States
GSK Investigational Site, San Diego, California 92103, United States
GSK Investigational Site, Fort Collins, Colorado 80528, United States
GSK Investigational Site, Gainesville, Florida 32610, United States
GSK Investigational Site, Decatur, Georgia 30030, United States
GSK Investigational Site, Iowa City, Iowa 52242, United States
GSK Investigational Site, Durham, North Carolina 27704, United States
GSK Investigational Site, Philadelphia, Pennsylvania 19140, United States
GSK Investigational Site, Madison, Wisconsin 53792, United States
Additional Information
Starting date: December 2006
Last updated: October 1, 2010
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