PrecISE is a severe asthma study. The purpose of PrecISE, is to find new treatments for severe asthma by using a new approach in medicine called precision medicine. Precision medicine is a method that tailors, or customizes, medicines to patients based on their biomarkers. Biomarkers are bits of information about you based on the results of different tests, including blood tests, analyses of your breath, and genetic tests. By using your biomarkers and testing different treatments in the study, we hope to learn more about treatments that are tailored to individuals and their needs. Please note that joining a research study is voluntary. You don’t have to join this or any research study.
This study is designed to investigate new treatments for asthma that are thought to work better in some patients than in others. The data from this research study will be used to determine which treatments work and what kind of patients a treatment benefits the most. If you choose to take part in the study, you can receive several different treatments, depending on when you begin the study.
You will take each treatment for about 4 months, and then take a break for 2 to 4 months before starting another treatment. The study will run for about 3 ½ years, and most of the people participating in the study will take 2-3 different treatments before finishing the study. Some of the treatment periods will involve a placebo instead of the active therapy. A placebo looks like the active treatment but doesn’t contain active ingredients. You will receive placebo in at least one of your treatment periods. You might receive placebo in one more treatment period after that, but you will never have more than two placebo periodstotal.
During the study, you will be asked to do the following, in some cases more than once: complete various questionnaires, get a physical exam, give blood and urine, get your lung function tested, produce a sputum (phlegm) sample and receive a CT scan, EKG and chest x-ray, ifnecessary.