Aria Adolescent Asthma Study

Asthma has dramatically increased over the past few decades in both developed and developing countries around the world. It is now the most common chronic childhood illness. Asthma is a chronic condition affecting the airways. Internationally, New Zealand has a high prevalence of asthma, with one in seven children aged 2–14 years and one in eight adults reporting taking current asthma medication.

About the investigational medication
The investigational medication is a combination of 3 medicines. This combination of medicines is currently approved in several countries around the world as the first once-daily, single-inhaler, triple therapy for the maintenance treatment of asthma in adults 18 years of age and older. This study will compare the study drug to an approved asthma maintenance medication (in certain countries) in adolescents with asthma. This study aims to compare a new triple-action Ellipta with the Ellipta Breo.

Reason to participate
Participating in a clinical study contributes to medical advancements and treatments. The results of this study can make a difference in the future care and treatment of Asthma for adolescents across diverse populations. Any research study may have risks, including feeling unwell or certain side effects. The study doctors, nurses and staff will review potential risks and benefits with the participant and caregiver before study enrolment.

Taking part in a clinical study is voluntary. If a person is eligible to enrol, they may choose to join the study but leave at any point at their discretion.

About the Study
This study is for adolescents 12 to 17 years of age who have been diagnosed with asthma for at least 1 year.

At the beginning of the ARIA study, all participants will be given a study-provided Ellipta inhaler to take once daily for 4 weeks. After this period, participants will be randomly assigned (by chance) to receive a study-provided Ellipta inhaler being investigated to take once daily for 24 weeks. Participants, caregivers, and the study team will not know the inhaler assignment. Participants will also receive an inhaled “rescue” medicine (albuterol/salbutamol) to take as needed for asthma symptoms during the study.

Participants will be in this study for approximately 7 months and have at least 6 study visits over this period. Depending on the visit, study visits may occur at the study clinic, over the telephone, or remotely (e.g., at home). Participants will be compensated for their time and travel.

Aim/Purpose:
The ARIA study is evaluating an inhaled study drug that combines 3 medicines in one daily inhaler. Already approved in several countries for adults, this is the first triple therapy of its kind for asthma maintenance. Now, we’re testing it against an approved asthma maintenance medication (Ellipta Breo) in adolescents to see how well it works.

These may include:
• Physical examinations
• Vital signs measurements (blood pressure and heart rate)
• Breathing assessments
• Questionnaires

Approximately 1000 people around the world will be participating in this study. This study involves diverse populations throughout the world and is being conducted in New Zealand due to our uniquely diverse population. Help contribute to the medical knowledge and treatment options for asthma in Aotearoa.