Are you/your child living with asthma attacks?

A clinical research study, also called a clinical trial or research study, is a carefully designed scientific evaluation of an investigational medication. Clinical research studies are conducted by doctors and researchers. A clinical research study helps to answer important questions about an investigational medication, such as:

• How safe is the investigational medication?
• Does it work?

An investigational medication (also called a "study drug") is a medicine that is still being researched. It has not yet been approved by health regulatory authorities for the condition you have.

Before a medicine can be researched in people, it is first studied in the laboratory and in animal studies. If those early results look promising, health regulatory authorities allow it to move forward to be researched in people, through clinical studies like the one you are being asked to join.

An investigational medication may also be a medicine that is already approved for one disease or condition, but is still being studied for use in a different disease or condition.

You can only receive an investigational medication as part of a clinical research study.

All investigational medications must go through clinical research studies before health regulatory authorities can approve them to be prescribed to patients. This is why people like you are needed to take part in clinical research studies – it is how new medications are developed and made available to patients in the future.

Teenagers are included in clinical studies because they are not simply "smaller adults". Rapid physical and hormonal changes uniquely affect how their bodies absorb and process medications. Testing treatments directly on teens prevents harmful side effects and ensures proper, age-specific dosing.

Before enrolling, both parents and teenagers must understand the risks, potential benefits, and regulations involved. The study team will explain the study to you and to your child at the first study visit. Throughout the study, a team of doctors and nurses will monitor their health. They will be there to answer any questions you may have. It’s the teenagers’ choice to join and they are allowed to change their minds about participating.

There are always risks and benefits to taking part in a clinical research study. There is always a chance that the investigational medication could cause side effects or may not work as hoped. It's important to weigh these risks carefully and make sure you understand them before deciding to join a study.

You should know that there are rules in place to help monitor the safety of everyone taking part in a study. The study team will explain all the risks and benefits to you at your first study visit.

Throughout the study, a team of doctors and nurses will monitor your health. They will be there to answer any questions you may have at any point during the study.

If you or your child pre-qualifies, a member of the research team at a nearby study location will contact you. They will explain the study in more detail, answer your questions, and guide you through the next steps. This will most likely include an in-person or virtual visit to check additional criteria and confirm your child's eligibility.

Research teams can be busy, so it may take a few days to receive a call or message. If it has been 3 or more days since you pre-qualified, you can call the study center at the phone number in your confirmation email.

If you or your child pre-qualifies, a member of the research team at a nearby study location will contact you. They will explain the study in more detail, answer your questions, and guide you through the next steps. This will most likely include an in-person or virtual visit to check additional criteria and confirm your or your child's eligibility.

Research teams can be busy, so it may take a few days to receive a call or message. If it has been 3 or more days since you pre-qualified, you can call the study center at the phone number in your confirmation email.

Each study has specific requirements to help keep participants safe and ensure meaningful results. You might not pre-qualify if your medical history, current medications, or other health-related factors do not match this particular study's requirements.

Not pre-qualifying does not mean anything is wrong with you, it simply means this specific study isn't the right fit right now. Other studies may have different requirements.

When you complete the questionnaire, your ZIP or postal code will be the key factor in trying to match you to a nearby study location. Every study has different locations. Sometimes one study location will close for enrollment while a new one will open. If there is no study location nearby when you complete the questionnaire, you can choose to be contacted if one opens later that is close to where you live or work. If the location offered to you is too far, you can decline.

The study-required investigational medication or placebo (which contains no active medicine) will be provided at no cost. You will also receive study-related care from a team of experienced doctors and nurses throughout the study at no cost.

You may also be reimbursed for time and/or travel related to study visits. Details of any compensation or reimbursement will be explained by the study team.

All personal information will remain confidential, and data will only be collected and used as necessary to support an individual's match to and participation in a study. Participants' names will not be included in any reported data. For more information, including how and why we process personal data, please read our Privacy Policy.

Clinical research studies must undergo rigorous reviews and follow strict rules. These rules help to ensure that the rights, safety, and well-being of participants are at the forefront of any study.

Participating in a clinical research study comes with risks as well as benefits. Before joining a study, potential participants must make sure they understand the benefits, such as getting access to study-related medical care and maybe helping others in the future. They must also understand the risks, such as unknown side effects. Potential study participants can take as much time as they need to decide whether to take part and get as much information as they can. Before joining a study, the potential study participant will be asked to sign an informed consent form, which will include a full explanation of the study, including its potential risks. If the potential study participant is not capable of giving informed consent, a legally authorized representative may provide informed consent on their behalf. In this situation, the potential study participant would provide informed assent.

It is a personal decision to take part. Participation in the study is voluntary. Please also consider:

• If a decision is made to participate, you/the person taking part can withdraw at any time during the study.
• The study team will explain the possible benefits and risks of the study during the informed consent process.
• A person does not have to join any study if they don’t want to.
• A team of doctors and nurses will carefully monitor the health of people taking part during the study.
• The investigational medication or placebo will be provided at no cost.
• Taking part in the study may help other people with asthma in the future.

People taking part in the study will need to follow all the instructions from the study doctor and nurses