Study for Children 6 to 11 Years Old 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 compare the study drug dupilumab with placebo in the treatment of uncontrolled persistent asthma in children 6 to 11 years old.

Who can participate?

Children 6 to 11 years old who:

  • Have uncontrolled persistent diagnosed

and

  • Have taken asthma medications including a controller inhaler and a reliever inhaler for at least one year

Conditions

  • Asthma
  • Chest and Lungs - Respiratory Tract

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.

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 $1,400 for study visits and follow-up visits over 64 weeks.

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.Sandy Durrani, MD
Division of Allergy and Immunology
Cincinnati Children’s Hospital Medical Center