ARASMI | Australian Respiratory & Sleep Medicine Institute

clinical trials: summit

A Clinical Outcomes Study to compare the effect of Fluticasone Furoate/ Vilanterol Inhalation Powder 100/25mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease.

≥40 and ≤80 years of age at Screening (Visit 1).
current or prior history of ≥10 pack-years of cigarette smoking at screening (Visit 1). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
Subjects with a measured post-albuterol/salbutamol FEV1/FVC ratio of ≤0.70 at Screening (Visit 1).
Subjects with a measured post-albuterol/salbutamol FEV1 ≥50 and ≤70% of predicted normal values calculated using NHANES III reference equations [Hankinson, 1999; Hankinson, 2010] at Screening (Visit 1).
Post-bronchodilator spirometry will be performed approximately 15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via an MDI with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated.
Subjects must score 2 or higher on the modified Medical Research Council Dyspnea scale (Visit 1)
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