TReating children to prevent

EXacerbations of Asthma (TREXA)

Who’s Eligible?: Children diagnosed with asthma, ages 6-17,who are currently
using a low dose of inhaled corticosteroids or children who are not taking daily
medications but are having frequent asthma symptoms.

Benefits to participation?:

• Compensation for time and travel.

• Medication is provided free of charge.
• Frequent physical exams by an asthma specialist.
• Learn more about asthma.
• Help other kids with asthma.
• Have fun with a friendly staff!

Purpose of the study: To see if children with mild asthma, who are under good
control, can safely stop using daily inhaled corticosteroids. Another purpose is to
see if using albuterol and an inhaled corticosteroid will provide better protection
against asthma attacks than using just albuterol as rescue medication.

What meds might my child take?: All participants will receive active QVAR®,
and Albuterol during the run-in. After meeting all criteria during the run-in, your
child will have active or placebo (inactive) QVAR® and active albuterol.

• QVAR® is the inhaled corticosteroid used in this study. It is FDA

approved for children with asthma.
• Albuterol is the “rescue” medication and is FDA approved.
• Prednisone, an oral corticosteroid, will be given to use only when
symptoms are uncontrolled by albuterol. It is FDA approved.

What can my child expect?: Over the course of the study, we will ask your child
to do complete daily diary cards, daily peak flow monitoring, take medications
regularly, and perform the following procedures:
 • IOS measures tightness in airways
• ENO measures the amount of nitric oxide in the lungs
• Spirometry measures air flow in and out of the lungs
• Reversibility is a test to see if albuterol improves lung function
• Methacholine challenge is a test to see how “twitchy” your airways are.
• Allergy skin testing
• Pregnancy tests (if applicable)
• Urine sample (optional) to look at features of asthma.
• Blood draw for features of asthma and genetic sampling. We use a
numbing cream so the “poke” doesn’t hurt.

How long is the time commitment?: Approximately 12 months which includes

9 clinic visits lasting 1.5-2.5 hours.

Who is Sponsoring this Study?: The National Heart, Lung, and Blood Institute
of the National Institutes of Health (NIH) is funding this study.

Primary Investigator: Robert F. Lemanske, Jr., M.D.

Sub-Investigators: Christine A. Sorkness, PharmD, Mark Moss, M.D.
Coordinators: Kelly Miller, B.S., Holly Eversoll, R.N., and Lisa Hurley, B.S.

For more information, call: (608) 263-3360/1-866-947-2273 (toll free) or email

pediatricasthma@medicine.wisc.edu.