Who can participate?
Children 6 to 11 years old who:
- Have uncontrolled persistent diagnosed
- Have taken asthma medications including a controller inhaler and a reliever inhaler for at least one year
What will happen in the study?
This study includes 31 study visits over 64 weeks. Here are some of the things that will happen in this study:
Your child will:
- Be randomly assigned to receive dupilumab or placebo, by chance like drawing straws (placebo looks like the study drug but does not contain the real drug).
- Continue to use his/her asthma controller inhaler and asthma reliever inhaler as instructed by the study doctor.
- Have a physical exam and measurements taken including blood pressure, height, weight, breathing rate, etc.
- Be asked questions about their medical history.
- Complete questionnaires.
- Be asked to perform breathing tests.
- Have a electrocardiography (ECG) which records the electrical activity of the heart over a period of time using electrodes placed on the skin.
- Submit blood and urine samples.
- Be given the study drug under his/her skin every 2 weeks for 52 weeks – home injections will be permitted if you and your child are comfortable with it and willing to do them.
- Receive a supply of reliever medication if needed.
You, as the parent or guardian, will be asked about your child including his/her asthma history, vaccination history, exposure to smoke, medical history, and current and past medications. You will also be asked to complete questionnaires.
If your child is eligible for the study, we will provide you and your child with an electronic diary/PEF meter and give you instructions about how to use them. Your child’s daily use of controller medication and reliever medication should be logged into the electronic diary.
Parents or guardians interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
What are the good things that can happen from this research?
Being in this study may not help your child right now. However, the information we learn from this study may be valuable in helping children with asthma in the future.
If your child is assigned to receive the active study drug, it is possible that the study drug may be effective in improving his/her asthma, by limiting asthma flares and improving asthma symptoms. If you child is assigned to placebo, it is not expected that he/she will receive a benefit beyond usual care.