Severe Asthma Study for Preteens and Teens 12 to 17 Years Old

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to look at the study drug tezepelumab compared to placebo (inactive medication) for the treatment of severe asthma in preteens and teens 12 to 17 years old.

Who can participate?

Preteens and teens 12 to 17 years old diagnosed with asthma who:

  • Have been to the doctor or hospital for asthma exacerbations or flare ups at least 2 times in the last year
  • Are taking a medium to high dose of an inhaled corticosteroid (ICS) and a second long-term controller medication

Conditions

  • Asthma
  • Chest and Lungs - Respiratory Tract

What will happen in the study?

There are 19 study visits over 70 weeks in this study. A detailed list of procedures will be provided to parents or guardians interested in knowing more about this study. Here are some of the procedures:

Your child will be randomly assigned (like drawing straws) to either receive the study drug tezepelumab or placebo. During the study, your child will continue to use his/her asthma controller inhaler and asthma reliever as instructed by the study doctor.

  • Your child will:
    • Have their blood pressure, pulse rate, respiration rate and temperature taken
    • Have an ECG (electrocardiography) to look at the pattern of your child’s heartbeat
    • Submit blood and urine samples
    • If female, have a pregnancy test
    • Complete breathing tests including lung function (spirometry) and peak expiratory flow (PEF) tests
  • You, as the parent or guardian, will complete or help your child complete:
    • Questionnaires at some of the study visits
    • An electronic peak expiratory flow (PEF) meter breathing test twice daily at home
    • An electronic diary to record your child’s symptoms, medications he/she has used, and overall health twice daily at home

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?

Being in this study may not help your child right now. If you child is randomly selected to receive the active study drug, it is possible that his/her asthma may improve. Overall, we hope that the information we learn from this study may benefit asthma patients in the future.

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

We will discuss possible risks and discomforts with parents or guardians interested in learning more about this study.

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

Families will receive up to $1,425 for 19 visits over 70 weeks for time and effort.

Contact

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

Study Doctor

Contact Us.Sandy Durrani, MD
Allergy and Immunology
Cincinnati Children’s Hospital Medical Center