Summary:
A clinical outcomes study to compare the effect of Fluticasone Furoate/Vilanterol Inhalation Powder with placebo on survival in subjects with moderate COPD and a history of or at risk for cardiovascular disease.
Inclusion Criteria:
- Subjects must give their signed and dated written informed consent to participate.
- Male or female. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy.
- Age: 40 to 80 years of age
- Tobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at screening ( Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
- Airflow Obstruction:
Determined by breathing tests.
Post-bronchodilator spirometry (breathing test) will be performed approximately 15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via a metered dose inhaler (MDI )with a valved-holding chamber.
- Symptoms of COPD: Subjects must score 2 or higher on the modified Medical Research Council Dyspnea scale (Visit 1)
- Cardiovascular disease:
For patients >= 40 years of age: any one of the following:
Established (i.e. by clinical signs or imaging studies) coronary artery disease (CAD) Established (i.e. by clinical signs or imaging studies) peripheral vascular disease (PVD) Previous stroke Previous MI Diabetes mellitus with target organ disease OR
For patients >=60 years of age: any 2 of the following:
Being treated for hypercholesterolemia Being treated for hypertension Being treated for diabetes mellitus Being treated for peripheral vascular disease
- Non Pregnant Women or not lactating
- Subject must not have a history of Asthma
- Subjects must not have alpha 1-antitrypsin deficiency
- Subjects must not have other respiratory disorders
Qualified Participants May Receive:
Study medication and rescue medication(albuterol).