Expired Study
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Clinical Trial 10569

Winter Park, FL 32789

Study Summary:

A clinical outcomes study to compare the effect of an investigational medication on survival in subjects with moderate chronic obstructive pulmonary disease (copd) and a history of or at increased risk for cardiovascular disease.

Qualified Participants Must:

• Give their signed and dated written informed consent to participate
• If female, be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception
• Be 40-80 years of age at screening (Visit 1)
• Have a 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
• Have an airflow obstruction:

  • 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.

• Dyspnea: Subjects must score 2 or higher on the modified Medical Research Council Dyspnea scale (Visit 1) RM2009/00666/02 confidential HZC113782 22 Have 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

Qualified Participants May Receive:

All study related medication and healthcare at no cost. Eligible participants will be compensated for the time and travel.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.