Study Stopped
The study was terminated due to difficulties with finding sites and subjects willing to participate.
ADVAIR DISKUS® (Fluticasone Propionate/Salmeterol) Inhaler Versus SEREVENT DISKUS® (Salmeterol) Inhlaer On Inflammatory Cells And Markers In Chronic Obstructive Pulmonary Disease. ADVAIR DISKUS® and SEREVENT DISKUS® Inhalers Are Trademarks of the GSK Group of Companies.
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 Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
180
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2006
Shorter than P25 for phase_4
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2006
CompletedFirst Posted
Study publicly available on registry
June 30, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedOctober 28, 2016
October 1, 2016
7 months
June 28, 2006
October 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of sputum neutrophils
Secondary Outcomes (1)
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
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (11)
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, 19107, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140, United States
GSK Investigational Site
Madison, Wisconsin, 53792, United States
Related Publications (1)
This study has not been published in the scientific literature.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2006
First Posted
June 30, 2006
Study Start
December 1, 2006
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
October 28, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.