Who can participate?
Infants and toddlers 5 to 16 months who:
- Have a parent or brother/sister at least 4 years old who has asthma
What will happen in the study?
This study includes 12 study visits and 26 phone calls over 3 years. Here are some of the things that will happen in this study:
Your child will be randomized into 1 of 2 study groups to receive either the study drug or a placebo (inactive capsule/pill). Being randomized means that your child will be put in one of the groups by chance, like flipping a coin.
Each visit will include some or all of the following:
You, as the parent or guardian will:
- Be asked about your child’s health, medications and possible surgeries
- Bring in your child’s study drug during the study to be counted
- Complete questionnaires about your child’s health and how it affects you and your child’s life
- Give your child the study capsule for 10 days each month (you can mix the powder from the capsule with fruit juice or other liquid for your child to drink)
- Be asked to collect 3 stool samples from your child over the course of the study
- Receive phone calls once a month for the months that you do not have a study visit to talk about your child’s health, medication use, asthma/wheezing symptoms, etc.
- Receive text messages to see if your child has had any breathing problems and to remind you to start giving your child the study medication
Your child will:
- Have a physical exam including length and height measurements, heart and breathing rates and oxygen level
- Have blood tests 3 times during the study (we can use a numbing cream on their skin)
- Have nasal washes with salt water (similar to tears) to flush your child’s nose
You 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.