Are you a parent with asthma or does your child have eczema?
If so, and your child is 5 to 16 months old, he or she may be eligible to participate in a new clinical study that may prevent the development of wheezing and asthma in children and help respiratory development.
The UNC Department of Pediatrics is studying whether wheezing and asthma can be prevented in at-risk babies.
To be eligible, participants must meet the following requirements:
- Child is between the ages of 5 - 16 months;
- Child has at least one parent/legal guardian who has a working cell phone and can communicate with study staff; and
- Must meet at least one of the following criteria:
- One of the child’s parents has asthma or has been diagnosed with asthma in the past; or
- Child has been diagnosed with eczema; or
- Child has a blood sibling, over 4 years of age, with a diagnosis of asthma.
The eligibility criteria are early indicators that your child may develop asthma in the future.
- If you are a parent with asthma,** your child is 3 times as likely to develop asthma because you have asthma. **
- If your child has eczema he or she is 46% more likely to develop asthma when compared to children who do not have eczema.
The ORBEX Clinical Study aims to help prevent or delay young children from developing asthma-like symptoms or wheezing. By potentially preventing children from developing asthma, a disruptive disease that requires lifetime management and causes stressors on both children and parents, children could have a healthier future.
What to expect when participating?
Study participants will be randomly selected to either receive a capsule of Broncho-Vaxom or a placebo.
Broncho-Vaxom is an investigational treatment that uses ingredients similar to a probiotic to boost the immune system, making it stronger to fight off respiratory infections. Broncho-Vaxom has already been used by 43 million children worldwide for over 20 years to prevent respiratory infections. This study is the first time, and currently the only way to access Broncho-Vaxom in the United States.
The placebo consists of non-active ingredients.
Participants will take the study drug via powder, once a month for 10 consecutive days each month for two years, and then observed for one year.
Participants will be compensated up to $1500 for their participation in the study.
To see if your child is eligible to participate in the ORBEX Clinical Study, please fill out the form or call 919-966-2333.
Recruitment for the ORBEX Clinical Trial is now closed.
Stephanie Davis, M.D.
Clinical Site Coordinators
Robin Johnson, RRT
Miriam Davis, RN, BSN, CCRP
UNC Department of Pediatrics
073 MacNider Hall
321 South Columbia Street
Chapel Hill, NC 27514