This study wants to learn more about CXA-10, a naturally occurring compound in the body. Researchers will test whether CXA-10 is safe and if it helps people who have asthma and are also living with obesity.
This study will help us learn more about treating hypertension in people who have asthma and are also living with obesity. It may help people with obesity-related asthma in the future. The drug being tested is investigational, which means it hasn’t been approved by the FDA for treating hypertension. If you join this study, you’ll be placed into one of two groups at random, like flipping a coin. You won’t know which group you’re in, and neither will the study team. One group will get CXA-10, the study drug. One group will take the study drug for six weeks, then take a placebo for another six weeks. The second will do the opposite. They will take the placebo first and then the study drug after. Between these two times, everyone will take a break from the study drug for four weeks. You may be asked to have a bronchoscopy, a test that lets the study team look inside your lungs. A thin and bendy tube with a tiny camera will be placed through your nose or mouth. You’ll get medicine to help you relax and numb your throat, so it doesn’t hurt. You’ll still be able to breathe during the test. Afterward, your throat might feel sore, and you may feel tired. You will also be asked to complete lung exercises that test your breathing along with other questionnaires. As part of the study, you will be asked to give a small blood sample and a stool sample. Your participation will be up to nine visits over the course of 22 weeks. If you are asked to complete a bronchoscopy, you will receive up to $1,275 for your participation.
Adults aged 18 to 65 years old who have been diagnosed with asthma and have a body mass index (BMI) of 30 or higher. Women who want to join the study should either be unable to get pregnant (because of age or surgery) or agree to use birth control if they can get pregnant.
Protocol Number: 21-3959
More information available at ClinicalTrials.gov: NCT03762395
Principal Investigator