A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Randomized, Double-Blind, Parallel-Group, 16-Week Study to Evaluate the Effect of Fluticasone Propionate/Salmeterol DISKUS® 250/50mcg BID and Placebo on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
249
1 country
24
Brief Summary
The purpose of this study is to evaluate in patients with Chronic Obstructive Pulmonary Disease (COPD) if Advair DISKUS™ 250/50mcg BID modifies arterial stiffness which is a measure associated with risk of heart disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2009
Shorter than P25 for phase_4
24 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
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 5, 2009
CompletedFirst Posted
Study publicly available on registry
March 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
December 23, 2010
CompletedJanuary 30, 2017
December 1, 2016
1 year
March 5, 2009
December 16, 2010
December 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Aortic Pulse Wave Velocity (aPWV) at the 12-Week Endpoint
The 12-week Endpoint is defined as the last scheduled measurement of PWV during the 12-week double-blind treatment period (from Visits 3-5; Weeks 4, 8, and 12, respectively), and Baseline is defined as the PWV measure from Visit 2 (Randomization). Change from Baseline was calculated as the Endpoint value minus the Baseline Value. PWV is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the PW along an artery is dependent on the stiffness of that artery.
Baseline and the 12-Week Endpoint (up to Week 12)
Secondary Outcomes (2)
Mean Change From Baseline in Augmentation Index (AIx) at the 12-Week Endpoint
Baseline and the 12-Week Endpoint (up to Week 12)
Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at the 12-Week Endpoint
Baseline and the 12-Week Endpoint (up to Week 12)
Study Arms (2)
ADVAIR DISKUS
ACTIVE COMPARATORSubjects receive blinded Fluticasone Propionate/Salmeterol. At 4 months subjects will receive open label SPIRIVA HANDIHALER
Placebo
PLACEBO COMPARATORSubjects will receive placebo ADVAIR DISKUS. At 4 months subjects will receive open label SPIRIVA HANDIHALER
Interventions
ADVAIR DISKUS™ 250/50mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS™ 250/50mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
Eligibility Criteria
You may qualify if:
- Signed and dated written informed consent obtained from the subject and/or subject's legally acceptable representative prior to study participation.
- Males or females greater then or equal to 50 years of age.
- A post-albuterol FEV1/FVC ratio of \< or equal to 0.70
- A post-albuterol FEV1 \< 80% of predicted normal.
- Patients can be current or fomer smoker and must have a cigarette smoking history of \> greater then or equal to 10 pack-years .
You may not qualify if:
- A current diagnosis of asthma
- A body mass index (BMI) of \> or equal to 35kg/m2
- A respiratory diagnosis other than COPD (e.g., lung cancer, bronchiectasis, sarcoidosis, tuberculosis, lung fibrosis).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (24)
GSK Investigational Site
Birmingham, Alabama, 35294, United States
GSK Investigational Site
Jasper, Alabama, 35501, United States
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Phoenix, Arizona, 85006, United States
GSK Investigational Site
San Diego, California, 92103-8415, United States
GSK Investigational Site
Torrance, California, 90505, United States
GSK Investigational Site
Hartford, Connecticut, 06105, United States
GSK Investigational Site
Coeur d'Alene, Idaho, 83814, United States
GSK Investigational Site
Sunset, Louisiana, 70584, United States
GSK Investigational Site
Minneapolis, Minnesota, 55407, United States
GSK Investigational Site
Chesterfield, Missouri, 63017, United States
GSK Investigational Site
Saint Charles, Missouri, 63301, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Downington, Pennsylvania, 19335, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
GSK Investigational Site
Charleston, South Carolina, 29406-7108, United States
GSK Investigational Site
Gaffney, South Carolina, 29340, United States
GSK Investigational Site
Greenville, South Carolina, 29615, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Union, South Carolina, 29379, United States
GSK Investigational Site
Johnson City, Tennessee, 37601, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
Morgantown, West Virginia, 26505, United States
Related Publications (2)
Dransfield MT, Cockcroft JR, Townsend RR, Coxson HO, Sharma SS, Rubin DB, Emmett AH, Cicale MJ, Crater GD, Martinez FJ. Effect of fluticasone propionate/salmeterol on arterial stiffness in patients with COPD. Respir Med. 2011 Sep;105(9):1322-30. doi: 10.1016/j.rmed.2011.05.016. Epub 2011 Jun 22.
PMID: 21696934BACKGROUNDBhatt SP, Cole AG, Wells JM, Nath H, Watts JR, Cockcroft JR, Dransfield MT. Determinants of arterial stiffness in COPD. BMC Pulm Med. 2014 Jan 4;14:1. doi: 10.1186/1471-2466-14-1.
PMID: 24387157DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
March 5, 2009
First Posted
March 9, 2009
Study Start
March 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
January 30, 2017
Results First Posted
December 23, 2010
Record last verified: 2016-12
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.