Frequently asked questions

Clinical research studies are used to test the safety and effectiveness of investigational study medicines. All investigational study medicines must be thoroughly tested before they can be used in medical practice. Clinical research studies take place to understand how these investigational study medicines can affect people and their conditions.

The investigational triple therapy inhaler used in the ARIA clinical research study has already been tested in 2,436 adults. It is approved for asthma treatment in adults in the USA, Japan, Australia and Canada. The ARIA study is evaluating whether this investigational triple therapy inhaler may also be beneficial for teenagers aged 12 to 17.

Health authorities such as The United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the European Union are responsible for reviewing and approving investigational study medicines for medical use. The study medicine in this clinical research study is called “investigational” because health authorities do not yet approve it for treating asthma in the study population, which is teenagers aged 12 to 17 years.

The ARIA clinical research study will help researchers understand the effectiveness and safety of the investigational triple therapy inhaler in teenagers aged 12 to 17 for the treatment of asthma, and determine whether it should be approved for use in medical practice.

Clinical research studies can occur in many locations, including hospitals, universities, doctors’ offices, and community clinics. In some cases, you may also receive home health visits as part of the study. Those who decide to participate in a clinical research study will receive detailed information regarding the study location and the option for possible home visits if this is permitted and approved for your study clinic.

If you are interested in the ARIA clinical research study, click here to find out if it is taking place in a clinic near you.

Participants will be in the ARIA study for up to 7 months and could have at least 6 study visits during this time. These visits will either be at the study clinic, or if permitted and approved, over the phone, or remotely from home. Involvement in the study is designed to have minimal impact on participants’ home and school life.

For those who choose to participate in the study, a full schedule will be provided with all the details needed for each study appointment. You will also receive communication and information materials to provide to your (or other relation) teenager’s school to ensure they are informed and can provide support and adjustments as necessary. This will help minimize disruptions to their school routine and allow them to continue participating in academic and social activities during the study.

Approximately 292 participants will take part in this clinical research study.

As a caregiver, you will need to:

• Talk to the study doctor or study staff about the study
• Accompany the participant to all study visits
• Provide information about the participant to the study doctor and staff
• Tell the study doctor or study staff if either you or the participant wants to stop being in the study
• Help the participant follow study instructions
• Tell the study doctor or study staff about any changes to the participant’s current medication use (including over-the- counter medications, vitamins, and supplements)

A side effect is an unwanted medical event that a medicine may cause. Like all medicines, the investigational triple therapy inhaler and the licensed double therapy inhaler may cause side effects, though not everyone will experience them. Some side effects could be serious or even life-threatening.

The safety and well-being of participants is our top priority. Before participation, potential participants and their caregivers will receive an Informed Consent Form detailing all the risks. The study doctor will also discuss these risks and answer any questions they may have.

Throughout the study, participants’ health will be closely monitored with regular check-ups and assessments to quickly identify and address any potential side effects or health concerns. The study site staff will always be available to answer questions and provide support, helping to ensure participants and their caregivers feel safe and informed.

During the study, participants will have regular check-ups, and their health will be closely monitored. Participation may or may not improve their asthma or provide direct benefits.

The knowledge gained through the study may help doctors better understand asthma treatment, and lead to better treatment options for people living with asthma in the future.

Participants can decide to stop participating in the ARIA clinical research study at any time without providing a reason, by informing the study team. Before taking part, potential participants and their caregivers will receive an Informed Consent Form, which provides further details on a participant’s right to withdraw.

Participants and their caregivers will be compensated for their study-related time and reimbursed for expenses incurred while participating in the clinical research study, for example; transportation, accommodation, and meals. Full details as to how much you will be reimbursed will be provided by a study site team member.

No payment is required to take part in this study. Participants will receive the study medicine, comparator medicine, rescue medicine, and all study tests and procedures at no cost.

The study team will collect participants’ health information, including name, age, medical history, and response to the treatment. This data is stored securely, and only certain people can access it. Identifying details are removed and replaced with a coded number to protect participants’ privacy.

For more information about the study, please click the button below to fill out a contact form. Only provide your contact details; do not include your (or other relation) teenager’s contact information. Participation is entirely voluntary, and your (or other relation) teenager is not obligated to enroll even if you request more information.