A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Completed · Phase 4 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT00857766

Run by

GlaxoSmithKline

People needed

249

Starts

2009-03-01

Expected to finish

2010-03-01

Last updated by the study team

2017-01-30

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Jasper, Alabama, United States
• GSK Investigational Site — Mobile, Alabama, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Torrance, California, United States
• GSK Investigational Site — Hartford, Connecticut, United States
• GSK Investigational Site — Coeur d'Alene, Idaho, United States
• GSK Investigational Site — Sunset, Louisiana, United States
• GSK Investigational Site — Minneapolis, Minnesota, United States
• GSK Investigational Site — Chesterfield, Missouri, United States
• GSK Investigational Site — Saint Charles, Missouri, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Downington, Pennsylvania, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Charleston, South Carolina, United States
• GSK Investigational Site — Gaffney, South Carolina, United States
• GSK Investigational Site — Greenville, South Carolina, United States
• GSK Investigational Site — Spartanburg, South Carolina, United States
• GSK Investigational Site — Union, South Carolina, United States
• GSK Investigational Site — Johnson City, Tennessee, United States
• GSK Investigational Site — Spokane, Washington, United States
• GSK Investigational Site — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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