Study for Children 2 and 3 Years Old Who Have a History of Allergies and Wheezing and a Family History of Asthma or Allergies

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to find out if the medication Xolair™ (approved for older children) helps prevent asthma in young children as they grow older.

Who can participate?

Children 2 and 3 years old who have wheezing, asthma and/or allergies or an immediate family member who has these conditions may be eligible to participate.

Conditions

  • Asthma
  • Chest and Lungs - Respiratory Tract
  • Allergy - Food Allergy

What will happen in the study?

This study includes study visits over 4 years.

Your child will be randomized – assigned a study group by chance, like flipping a coin – into one of two study groups. One group will take Xolair™, and the other group will take placebo (inactive fake medication).

The study is conducted in three parts:

  1. Screening
  2. Monthly study medication treatment for 2 years
  3. Observation (no study medication) for 2 years

All children in the study will be given standard medications and managed by the study doctor for the treatment of breathing symptoms, such as wheezing and cough during the study period.

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, he/she will receive allergy and lung tests and frequent monitoring, education and treatment for breathing problems which may help with their health.

Overall, when we complete this study, we hope that we will know more about the study medication Xolair™. This could help children with asthma 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?

Participants will receive health exams and breathing evaluations at no charge and compensation for time and travel.

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
Asthma Center
Cincinnati Children’s Hospital Medical Center