What is COPD?
COPD is a chronic condition of the lungs, in which the main cause is smoking tobacco, but other factors have been identified. It results in progressive airflow obstruction that is only partly reversible or even irreversible. The disease is
further aggravated by exacerbations, particularly for severe COPD. According to WHO estimates, 65 million people have moderate to severe COPD worldwide. While there is no cure for COPD, symptoms can typically be improved/controlled.
What is the EFC15805 COPD Clinical Study?
EFC15805 is a clinical research study being conducted by respiratory disease doctors to determine if the study medication can reduce the rate of moderate to severe acute exacerbations of COPD, over a maximum of one year of treatment. The study medication (one not yet approved in COPD by the health authority) called Dupilumab is an injectable medication as opposed to the most commonly used COPD medications which are inhalers. The clinical research study will also evaluate if the study medication helps to improve the way patients feel, their level of activity and breathe, which may potentially reduce the need for rescue or reliever medications. Patients on this study will receive either Dupilumab or placebo. Placebo is an inactive solution that does not contain medication. Study medications and/or placebo will be injected under the skin (“subcutaneously”) once every 2 weeks. You have a 1 in 2 (or 50%) chance of receiving placebo only, on this study. You will continue taking your background therapy while on the study.
This study is for people who have moderate to severe COPD, and are currently being treated with standard of care therapy. This therapy must include LABA and LAMA with inhaled corticosteroid treatment or if inhaled corticosteroid treatment is contraindicated for you with LABA and LAMA only. Common examples of these medications would include Advair, Symbicort, Dulera, Alvesco etc. as an inhaled corticosteroid, Serevent, Advair, Breo and Anoro Ellipta, Brovana etc. as a LABA, and Spiriva, Anoro Ellipta, Stiolto, Trelegy, Tudorza etc. as a LAMA, though there are several others. If you are taking this treatment for at least 3 months, you may qualify for this study.
If you enroll in this study you will receive all study-related medical care at no cost to you. Also, if you enroll, you will be seen by a doctor who will closely watch your COPD.
