Children and Teens 6 to 17 Years Old with Mild to Moderate Persistent Asthma Needed for CREON2000A Ultraviolet Air Purifying Device Research Study

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to see if using an ultraviolet air purifying device, called the CREON2000A, to reduce or eliminate allergens and microbes in the home will improve asthma control and symptoms for children with asthma.

The CREON2000A is an investigational device and has not yet been approved by the FDA.

Who can participate?

Children and teens, 6 to 17 years old, who have been diagnosed with mild to moderate persistent allergic asthma may be eligible to participate. A participant’s primary residence, of 3 or more days a week, must have a central air heating and air conditioning (HVAC) system.

Your child cannot be in this study, if he or she:

  • Is a current smoker or lives in a home with smokers
  • Lives in a home with active fireplaces and other sources of air particulates (wood burning stoves, kerosene heaters) or more than one HVAC furnace system
  • Has been diagnosed with a chronic lung disease other than asthma
  • Is known to have any other chronic illness (besides asthma) that is not well controlled at the time of the first visit
  • Had an upper or lower respiratory infection within 4 weeks prior to enrollment
  • History of a life threatening asthma attack, hospitalization in an intensive care unit or hospitalization for asthma within 6 months prior to the first visit
  • Is building up on allergen immunotherapy and is not on a stable maintenance dose
  • Is allergic to and symptomatic around pets in the home
  • Has uncontrolled skin rashes

Conditions

  • Asthma

What will happen in the study?

If your child qualifies for this study and you decide to participate, there will be 4 visits to the Allergy Clinic at Cincinnati Children’s (each lasting 1 to 3 hours), 2 home visits (each lasting 2 to 3 hours), and 7 study phone calls (each lasting 20 minutes) over a 12 month period.

The following will occur during 1 or more study visits:

  • Collection of demographic (personal) information
  • Review of medical history
  • Review of medication history: including current list of medications, number of doses/puffs your child has used over a 2 week period, changes to asthma medications
  • Physical exam: including height, weight and vital signs
  • Questionnaires: about your child’s asthma and rhinitis (inflammation in the nose)
  • Spirometry testing: a lung function test measuring how much and how quickly air moves out of the lungs
  • Allergen skin testing: a small amount of an allergen is placed under the surface of the skin via a prick or scratch and watched for an allergic reaction
  • Urine pregnancy test: done prior to skin testing (if it’s necessary) if your child is female and menstruating
  • Diary: you will record how often your child uses albuterol

Your child will first have a Screening Visit to determine if he or she is eligible to participate in the study. During the visit, your child will complete various tests/procedures and answer questions. A study nurse or doctor will also ask you to take a picture of your furnace and email it to them to make sure the CREON2000A unit will fit.

If your child is eligible to continue in the study after the Screening Visit, he or she will be randomly assigned by chance (like the flip of a coin) to either have the CREON2000A or placebo (sham) installed in your home ventilation duct. A sham is a device that has been modified to have no effect on the content of the air quality in your house and therefore will have no effect on your child’s asthma.

Neither you nor the study doctor will know which of these device groups your child is assigned. In case of an emergency, however, the study doctor can get this information.

Arrangements will be made for a technician to come to your home at a time convenient for you and install either a CREON2000A or a sham unit in the ventilation duct of your home’s furnace. The technician will also get some samples of dust from the furnace filter and your child’s bedroom carpet. He will then attach a small electronic device (HOBO data logger) to a wall in your child’s bedroom that will collect temperature and humidity values throughout the study.

After the instillation of your assigned device, your child will have 3 more follow-up visits at Cincinnati Children’s and 7 phone calls with study staff.

At the end of the 12 month study, the technician will come back to remove the CREON2000A/sham. He will also remove the HOBO electronic unit and collect final samples from the furnace filter and carpet in your child’s bedroom.

If at that time you decide you want to keep/receive an active CREON200A unit for use in your home, the company will ship one to you. The unit will come with a new UV bulb and HEPA filter installed, at no cost to you and with a one year warranty.

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 or may not receive a direct medical benefit from being in this study right now; however, when we finish the study, we hope to know more about whether using CREON2000A helps to reduce asthma and allergic rhinitis symptoms. This may help other children with asthma later on.

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

Possible risks and side effects will be provided to and discussed with those parents, legal guardians and participants interested in knowing more about this study.

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

Participants will receive up to $200 for their time, effort and travel. Participants will also keep a real CREON2000 unit at the completion of the study, no matter which group they were randomized into, if they so choose.

Contact

Contact Us.Christina McDougall
513-636-2733
christina.mcdougall@cchmc.org
Cincinnati Children’s Hospital Medical Center
Division of Allergy and Immunology
3333 Burnet Avenue
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Michelle B. Lierl, MD
Division of Allergy and Immunology
Cincinnati Children’s Hospital Medical Center

CCHMC IRB #2015-7813: V1