AIM4 – Parent of an Adolescent 12-17

STUDY BASICS

Are you the parent of a 12–17-year-old with asthma? Your child may be eligible for a research study to see which treatment works better: taking study drug with inhaled asthma drug (i.e., an “inhaler”) or taking a higher dose of the inhaled asthma drug in the inhaler. Participants will be in the study for up to 58 weeks. Compensation is provided.

STUDY PURPOSE

This study is being done to study a drug and a breathing condition known as asthma. Asthma is a common breathing condition that causes your airway to become swollen and narrowed, which makes it harder for air to flow in and out of your lungs when you breathe. Uncontrolled asthma means that you are still having trouble breathing while taking medication. The aim of the study is to see which treatment works better: taking study drug with inhaled asthma drug (i.e., an “inhaler”) or taking a higher dose of the inhaled asthma drug in the inhaler.

COULD THIS STUDY BE RIGHT FOR YOU?

Parent of an adolscent:

• Ages 12 - 17
• Diagnosed with asthma
• Currently uses an Inhaled Corticosteroids (ICS) and long acting bronchodilator (LABA)
• Has had at least one asthma flare-up in the past year

WHAT PARTICIPANTS CAN EXPECT

If your child joins, they will be in the study for up to 58 weeks:

• Screening period - 2 weeks to see if they qualify
• Run in period - 4 weeks - to learn to use the study inhaler(s)
• Your child will be assigned by chance (like flipping a coin) to receive either study drug and the same inhaler your child received during the run-in period or a placebo injection and a higher dose of the asthma inhaler your child received during the run-in period.
• Medication - for 52 weeks your child will receive the study treatment and complete 9 visits - they will see the study doctor during these visits