Introduction to the ARIA clinical research study

Learn more about the ARIA clinical research study and what the enrollment criteria are.

The ARIA study explainer video

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One of the current medicines licensed for the treatment of asthma is a once daily, single inhaler, double therapy containing two medicines: fluticasone furoate and vilanterol (FF/VI). This double-therapy inhaler is licensed to treat asthma in patients aged 5 years and older.

The ARIA clinical research study is evaluating a similar once daily, single inhaler, triple therapy containing three medicines: fluticasone furoate, vilanterol and umeclidinium (FF/VI/UMEC), for the treatment of asthma in teenagers aged 12 to 17 years. This triple therapy inhaler (FF/VI/UMEC) is already licensed to treat asthma in adults aged 18 and older in the USA, Japan, Australia, Canada and other countries.

To perform this evaluation, the investigational triple therapy inhaler (FF/VI/UMEC) will be compared to the double therapy inhaler (FF/VI) in teenagers over 24 weeks.

All participants will receive either the double or triple therapy asthma treatment, and quick relief “rescue” treatment to use as needed for asthma symptoms throughout the study.

Who can take part?

To join the study, participants must:

Be aged 12 to 17 years old inclusive

Have uncontrolled asthma

Have been on stable maintenance therapy for at least 6 weeks

This is not a complete list of criteria; potential participants and their caregivers will need to answer additional health questions and undergo medical tests to confirm that they can join the study.

What can participants and their caregivers expect?

Participants will be in this study for approximately 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 as minimal an impact as possible on home and school life.

Participants will receive a detailed schedule for each study appointment. Communication and information materials will be provided to share with your (or other relation) teenager’s school, to ensure they are informed and can offer support and adjustments as needed. This helps minimize disruptions to their school routine, allowing them to continue their academic and social activities during the study.

How will the study medicines be given?

All participants will start by taking the double therapy inhaler (FF/VI) once daily, in the morning for 4 weeks.

After this period, participants will be randomly assigned to either continue with the double therapy inhaler (FF/VI) or switch to the investigational triple therapy inhaler (FF/VI/UMEC), both taken once daily, in the morning, for the next 24 weeks.

Throughout the study, neither participants, caregivers, nor the study team will know which inhaler has been assigned. This information can be accessed if necessary for safety reasons.

All participants will also receive a quick relief “rescue” medicine inhaler (albuterol/salbutamol) to use as needed, for asthma symptoms during the study.

How will participants’ health be monitored during this study?

Participants’ health will be closely monitored through regular visits. These visits will include various tests and assessments*, such as:

Physical examinations

Vital signs measurements (blood pressure and heart rate)

Breathing assessments

Questionnaires

Blood tests

*Not all of these activities will occur at every visit.

Each visit could take around 2 hours and is designed to be convenient and efficient for participants and their caregivers. We aim to minimize disruption to participants’ daily lives while ensuring thorough monitoring of their asthma symptoms and general health.

Are you interested in finding out more about the ARIA study for your teenager?

If you care for a teenager between 12 and 17 years old and would like to see if they would be eligible for the ARIA clinical research study and register your interest in their participation, please click the button below. 

Parent and caregiver information brochure

You can also view and download our information brochure to learn more about the ARIA study

Find out more about the ARIA clinical research study

Asthma won’t
hold us back

An overview of the ARIA clinical research study, asthma and clinical research studies

An introduction to the ARIA clinical research study

Complete a short questionnaire and find out if there is an ARIA study site near you