Asthma Research Is In The Air

The FLAIR Study is evaluating an investigational drug for children and adolescents with asthma.

About the Study

The FLAIR Study is evaluating an investigational drug to see how it works in reducing the severity and frequency of “asthma attacks”.

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See if Your Child Qualifies

If your child is 4 years old or older and has been diagnosed with asthma for at least 1 year, they may qualify for the FLAIR Study.

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Who can participate in the FLAIR Study?

The FLAIR Study is evaluating an investigational drug to see how it works in reducing the severity and frequency of “asthma attacks” in children and adolescents.

To participate in this study, your child must:

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Be 4 years of age or older

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Be diagnosed with asthma for at least 1 year

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Had 1 or more asthma attacks in the past 12 months that was considered severe or required treatment

There are also other requirements that will determine who can participate. A doctor will determine if your child is medically eligible to take part in this study.

See if Your Child Qualifies

Fill out the form below to help determine if your child may be eligible for the FLAIR Study.

Children ages 4 and over, who have been diagnosed with asthma for at least 1 year and have had 1 or more asthma attacks requiring treatment in the past 12 months may qualify for the FLAIR Study.

If you are under the age of 18, you may not directly enter any information, and your legal parent or guardian must enter this information on your behalf.

About Asthma

Asthma is one of the most common chronic diseases affecting people of all ages.

If a person has asthma, the airways in their lungs can become swollen (inflamed) and narrowed at times, causing breathing difficulties like wheezing and chest tightness.

There are certain factors that can set off or worsen asthma symptoms, such as pollen, exercise, viral infections, or cold air. These are called “asthma triggers.” When asthma symptoms get worse, it is called an asthma exacerbation or an “asthma attack.”

The FLAIR Study: What to Expect

The FLAIR Study is evaluating an investigational drug to see how it works in reducing the severity and frequency of asthma attacks in children, adolescents, and adults.

The investigational drug is a combination of 2 commercially approved drugs used separately to treat asthma, administered through a single inhaler. The investigational drug will be administered using an inhaler device. Your child will have an equal chance of receiving the investigational drug in high or low dose, or receiving albuterol sulfate (ABS, also known as salbutamol), which is a common drug used for the rescue treatment of asthma.

Screening Period (approximately 2 weeks)

You and your child will be visiting the research center for tests and assessments to see if they qualify to take part in the FLAIR Study. The screening procedures, including taking a medical history, and a physical examination, may take place at 1 or more visits.

Run-In Period (approximately 2 to 4 weeks)

Your child will receive a rescue inhaler to use at home along with their usual asthma treatment. You’ll visit the center once for training on inhaler use and receive a diary to track symptoms and medication use. A home spirometer will also be provided for daily lung function checks.

Study Treatment Period (at least 24 weeks)

If eligible after the Run-In Period, your child will receive the study inhaler to use at home. During this period, they’ll visit the center every 3 months. In between research center visits, the study team will contact you by phone every month to ask how your child is feeling.

End of Study/End of Study Treatment Visit

These visits will be scheduled when the study is completed or if you stop the study treatment and leave the study early.

Participation in the FLAIR Study is completely voluntary. If your child takes part in the study, they can end their participation at any time and for any reason. If they decide not to participate, it will not affect your medical care now or in the future.

Common Questions

What is a clinical research study?
A clinical research study, also called a clinical trial, is carefully supervised research that is done before a study drug is approved for use in larger populations.

Clinical studies follow specific rules to protect the rights, safety, well-being, and confidentiality of study participants. The results help government regulators decide if a study drug is safe and should be made available to the public. Clinical studies are the only way to develop new medical treatments.

What is the investigational medication being researched in this study?

The FLAIR Study is evaluating an investigational drug to see how it works in reducing the severity and frequency of asthma attacks in children, adolescents, and adults. The investigational drug is a combination of 2 commercially approved drugs, fluticasone propionate and albuterol sulfate, used separately to treat asthma, administered through a single inhaler.

Are there costs or compensation involved in participating in this study?
It will not cost anything to take part in this study. Where regulations allow, participants and caregivers may be fairly compensated for their travel, time, and effort for the duration of the study.
How will my child be monitored during the FLAIR Study?
During the study, the study team will monitor your child’s health. Laboratory tests (blood and urine), physical examinations, lung function tests, heart assessments, questionnaires, and other procedures will be conducted as part of the study. You or your child will also be asked to enter information about your child’s asthma symptoms into an electronic diary twice daily and your child will do a breathing test (spirometry) each morning at home.
What are my child’s rights as a participant and what will happen if they decide not to participate?
Participation in the FLAIR Study is completely voluntary.

If your child decides to take part in the study, you can end their participation at any time and for any reason. If they decide not to participate, it will not affect their medical care now or in the future.

Find a Research Center Near You

Current Research Centers working with pediatric and adolescent participants are listed below. Additional Research Centers may be added at any time.