Study for Infants and Toddlers Who Have Eczema and/or a Sibling or Parent With Asthma

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about a study drug called Broncho-Vaxom® to treat children who are of high risk to develop asthma, in an attempt to prevent or reduce viral infections and wheezing.

Who can participate?

Infants and toddlers 5 to 16 months who:

  • Have eczema

and/or

  • Have a parent or brother/sister at least 4 years old who has asthma

Conditions

  • Asthma
  • Dermatology - Skin
  • Chest and Lungs - Respiratory Tract

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.

What are the good things that can happen from this research?

Your child may not have a direct medical benefit right now. However, he/she may benefit from frequent monitoring of their wheezing symptoms over the 3 years that he/she is in in the study. When we complete the study, we hope that we will know more about the study drug Broncho-Vaxom® as a preventative medicine for wheezing illnesses. This may help children who are at high risk from wheezing illnesses in the future.

What are the bad things that can happen from this research?

Possible risks and discomforts will be discussed with parents or guardians interested in learning more about the study.

Will you/your child be paid to be in this research study?

Families will receive up to $1,360 for 12 study visits and 26 phone calls over 3 years for time and effort.

Contact

Contact Us.Study Coordinator
513-803-3735
pulmasthmaresearch@cchmc.org
Asthma Center
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Theresa Guilbert, MD
Cincinnati Children’s Hospital Medical Center