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The reason for this research study is to look at whether the study drug is safe and effective in decreasing the symptoms of chronic obstructive pulmonary disease. Two hundred and fifty adults between the ages of 40 years to 75 years will be part of this study. About seven countries worldwide will participate. All participants will be randomly assigned to receive either the study drug or a placebo. A placebo is a look-alike tablet that contains no active ingredients. This is a double blind study which means that neither you nor the study doctor and staff will know whether you are taking the study drug or the placebo. There will be no charge for the study drug, study visits or tests that you will receive while in the study.
This research study will evaluate whether the study drug is safe and effective in decreasing the symptoms of chronic obstructive pulmonary disease. You will need to take the study drug at the same time every day. You will receive information about potential side effects of the study drug during the informed consent discussion. You will be able to continue use of your inhaled short-acting ß-agonist drug as needed throughout the study. The study doctor will review with you at each visit, an “action plan” if your COPD were to worsen.
If you participate, the research study doctor will perform physical exams, do blood tests, perform a chest x-ray and electrocardiogram (ECG), administer specialized lung tests, and give you study drugs. You will receive a copy of the “Visit-By-Visit” Planner so that you will know what to expect at each appointment. You will be required to fill out a diary every day that asks specific questions regarding your COPD symptoms and drugs you take for those symptoms. You will need to give the completed diary to the study staff at each visit and a new one will be given to you. There will be 8-9 visits over a 14 week period. It is very important that you keep every appointment so that the study doctor can closely monitor your progress during the study. If you need to reschedule an appointment, please call the office so that they can give you a more convenient time.
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If
you are eligible to join the research study, the study doctor or his/her
staff will discuss all the study details with you. They will ask you
to sign an Informed Consent form. Please ask as many questions as you
need to make sure that you understand the study requirements as well
as the risks and the potential benefits of participating. You are also
welcome to ask questions at any time during the study. The decision
whether to participate is yours alone to make, and you can decide not
to participate at any time.