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Clinical Trial 17639

Mission Viejo, CA 92691


Study Summary:

About the HZA Asthma Studies

The HZA Asthma Studies for Children are clinical research studies being done to test the safety and effectiveness of investigational inhaled medications for the potential treatment of persistent uncontrolled asthma in children 5 to 11 years of age. It is important to study asthma medications in children to see how their growing bodies respond and to find the safest and best dose to treat their asthma symptoms.

The HZA 853 Study is testing the safety and effectiveness of three different doses of an investigational medication called vilanterol in children with asthma.

Vilanterol is a long-acting beta-agonist. It works by relaxing the muscles around your child’s lungs. This drug helps to open your child’s airways and make breathing easier. Vilanterol is a fine dry powder, which your child will breathe in through the mouth from an inhaler. In this study, your child will get one of three doses of vilanterol or a sugar powder that does not contain any medication, called placebo.

This study will last about nine weeks. During this time, you and your child will need to visit the study clinic about six times.

The HZA 855 Study is testing the safety and effectiveness of three different doses of an investigational medication called fluticasone furoate to see how well it works in children with asthma and to determine which dose works best for children.

Fluticasone furoate works to decrease the inflammation (redness and swelling) in your child’s lungs. Decreasing the inflammation helps to open your child’s airways and makes breathing easier. Fluticasone furoate is a fine dry powder, which your child will breathe in through the mouth from a new inhaler.

This study will compare fluticasone furoate with an approved medication called fluticasone propionate and with a sugar powder that does not contain any medication, called placebo. Fluticasone propionate is an inhaled corticosteroid (ICS) medication that is already prescribed to children ages 5 to 11 with asthma. Fluticasone furoate is considered investigational in this study because it is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of asthma.

The study will last for about four months. During this time, you and your child will have to visit the study clinic about seven times.

What will happen at study visits?

At the visits, the study doctor will ask you questions about how your child is feeling and do some tests to monitor your child’s health, including breathing tests and blood tests. The study doctor will also weigh your child, take his or her blood pressure, and measure his or her pulse rate.

What are the potential risks and benefits?

The study doctor will explain all of the potential risks and benefits of participating in a clinical research study. Your child may or may not benefit from being in an asthma study. Your child will be given and can use quick-relief medication for his or her asthma symptoms throughout the study, if needed. The information learned from the studies and your child’s participation may help improve treatment options for children with uncontrolled asthma in the future.

Who can participate?

Your child may be eligible to join an asthma study if he or she:

• Is 5 to 11 years old
• Has been diagnosed with persistent uncontrolled asthma for at least 6 months
• Has been using a short-acting beta agonist (SABA) asthma inhaler such as Proventil, Ventolin, Proair, Xopenex, or Alupent and/or another asthma controller medication for at least 4 weeks
• Does not use a long-acting beta agonist (LABA) asthma inhaler such as Serevent, Advair, or Foradil

Does it cost my family anything to participate?

All study participants will receive the study medications and study-related tests and procedures at no charge. Your family may also receive payment for your time and study-related expenses.

Where are the studies taking place?

Click here for a list of study locations.

For more information or to find out if you qualify, visit The HZA 855 Study.