This clinical research study is testing the safety and effectiveness of a new investigational medication for qualified individuals with moderate to severe COPD.
You may be eligible to participate if you are 40-80 years old and have been diagnosed with moderate to severe COPD.
This study is being conducted to determine the safety, efficacy, and tolerability of an investigational medication (dupilumab) in patients with moderate to severe COPD. This medication is designed to work in conjunction with your existing triple therapy (inhaler) treatment. Dupilumab is currently FDA-approved for the treatment of atopic dermatitis, asthma, and chronic sinus infections with nasal polyps.
The BOREAS Study is a randomized, double-blind, placebo-controlled clinical trial. This means that neither you nor study staff will know whether you are taking dupilumab or the placebo. A placebo is a medication that looks exactly like the study drug but does not have any active ingredients. You will be assigned to either the investigational medication or placebo at random, much like the flip of a coin.
This study is being conducted in three periods. The screening period will last about 4 weeks, during which time study staff will go over your medical history and conduct a physical exam to determine your eligibility for the study. If the study staff determines that you are qualified, you will be randomized into the study, initiating the 52-week treatment period. At this time, you will receive a dupilumab or placebo injection once every two weeks, either at home or at the study site. After the treatment period ends, you will enter into a 12-week follow up period in which study doctors will monitor any changes to your health.
Smoking history includes cigarettes, e-cigarettes, cigars, pipes, etc.
There are additional study requirements to participate. A study representative will discuss them with you.
COPD, or chronic obstructive pulmonary disease, is a chronic lung disease which blocks airflow to the lungs, making it difficult to breathe. Long-term cigarette smoking is the most common risk factor for developing COPD, but other factors like short- or long-term exposure to chemicals, exposure to fumes from fuel, asthma, and genetics are also risk factors. At this time, there is no cure for COPD, but it can be managed with the right treatment plan.
Shortness of breath or difficulty breathing
Frequent respiratory infections
A clinical research study tests the safety and effectiveness of a new investigational medication in human volunteers. Every investigational medication goes through the clinical trial process. Therefore, participants play a very important role in advancing medicine for present and future generations.
An investigational medication has not yet been approved by the U.S. Food and Drug Administration (FDA) for treatment but is allowed to be administered to people for research purposes.
A placebo is often similar in appearance to the investigational medication but does not contain any active ingredients. Placebos are designed to look exactly like an investigational medication so that neither you nor study staff will know which treatment you are receiving.
Your participation in this study is voluntary. You can decide to stop at any time, and you may still be treated at the facility. Your decision whether or not to take part in the study will not affect your current or future care at the facility.
Tell your study doctor if you are thinking about stopping or decide to stop. You should talk to the study doctor about leaving the study before you decide so that he/she can find out if you are having any side effects from study treatment, and he/she can tell you how to stop safely. Another reason to tell the study doctor that you are thinking about stopping is so that he/she can talk to you about any other treatments, follow-up care, and/or testing that could be helpful to you.
If you decide to stop participating in this study, you will be asked to come back to the research site for an Early Termination Visit. This information is important to make sure there are no lasting side effects from the investigational medication and to see if your disease got better, stayed the same, or got worse.
You are asked to follow, without exception, the rules and instructions listed within the Informed Consent for the study. If you do not follow these rules and instructions, you may be withdrawn from the study.
In order to provide maximum protection for your health, the study will be under the direct supervision of the study doctor and will be conducted by trained personnel. You will need to provide all information about your current and past health (medical history) at the Screening Visit and at each Follow-Up Visit, including participation in any other research studies. This information is needed to protect your health.
If you have a personal doctor, it is strongly recommended that you inform him/her if you participate in this research study.
Current study locations are listed below and more may be added at any time. If you are interested in participating in the BOREAS Study, complete the form to speak with a study representative regarding your eligibility and available study locations.