About the Asthma Studies

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What are the Asthma Studies for Children?

These studies are testing the safety and effectiveness of two different investigational inhaled medications for the potential treatment of persistent uncontrolled asthma in children ages 5 to 11.

The HZA853 Study

About 460 children aged 5 to 11 years old in multiple countries will take part in this study.   

What are the study medications?

This study is testing the safety and effectiveness of three different doses of an investigational medication called vilanterol in children ages 5 to 11 with asthma. 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. 

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 will be breathed 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.

How long will the study last?

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

The HZA855 Study

About 575 children aged 5 to 11 years old in nine countries will take part in this study. 

What are the study medications?

This 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 will be breathed in through your child’s 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 already prescribed to children ages 4 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 patients for the treatment of asthma.

What will my child have to do in the study?

Your child will have to stop taking his or her usual quick-relief medication at the first study visit and will be given another quick-relief medication to use for his or her asthma symptoms during the study if needed.

Your child will continue his or her current asthma controller treatment at the first study visit and for four weeks after that. At the third study visit, your child will stop taking his or her current asthma controller treatment and start taking study medication. There is a 40 percent chance that your child will receive placebo or fluticasone propionate and a 60 percent chance that your child will receive fluticasone furoate.  

Your child will be given an inhaler with study medication to take one puff every evening as well as a DISKUS/ACCUHALER to take one puff every morning and evening.  Your child will need to use both inhalers every day for 12 weeks. 

How long will the study last?

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.

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

Printable study fact sheet Download fact sheet

 

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an Asthma Study is an option for your child.