Summary:
About this clinical research study
This clinical research study is being conducted worldwide to test the long-term benefits of the study drug versus placebo in reducing lung and heart complications. A placebo is a substance that looks similar to the study drug but contains no active medication.
This study will enroll 16,000 participants who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD), and a history or risk of heart disease, in approximately 1,100 study centers.
The study drug is a new drug that combines both a long-acting beta-agonist and a corticosteroid in a single inhaler in order to relax the airways in the lung, helping to make breathing easier. The study drug has not been licensed for use in the prevention of mortality, which is why it is being studies first.
Individuals may qualify if they:
- Have a diagnosis of moderate COPD
- Have a history or risk of heart disease
- Are between 40 and 80 years of age
- Are a current or former cigarette smoker
There are other study requirements that will determine if you qualify for this clinical research study.
Study participants may receive investigational study drug, study-related medical care and study procedures at no charge.
Why should I participate in this clinical research study?
Clinical research studies like this one are necessary to help find new and possibly better future treatments for diseases. Without proper research, no new medications or medical devices could be made available to the public.
Although there is no guarantee the investigational study drug in this study will provide any benefit, the information collected by researchers could be useful to help treat COPD in patients in the future with a history or risk of heart disease.
Volunteering to participate in a clinical research study is an important decision and should be thought through carefully. Participating in a clinical research study is voluntary. Participants have the right to discontinue taking study drugs at any time, for any reason, without penalty or loss of benefits to which the participant is otherwise entitled.
Participants in the study will receive, at no cost:
- Direct access to study doctors or nurses who will answer questions and concerns
- Study-related physical exams
- Blood work and other laboratory services
- Investigational study drug
You do not have to participate in this clinical research study to receive treatment. The study doctor will discuss any other available treatments that may be right for you.