Study Name:
Asthma Research In Adolescents
Targeted Disease(s):
Asthma
Purpose of Study:
The ARIA study is evaluating the efficacy and safety of a triple combination treatment (FF/UMEC/VI) administered via a once-daily, multi-dose, dry powder inhaler. This treatment has already undergone a safety evaluation in 2,436 adults with uncontrolled asthma on inhaled corticosteroid plus long-acting β2- agonist (ICS/LABA) therapy. Results showed that adding UMEC improved lung function compared to FF/VI, with similar safety profiles across both treatment combinations.
As a result of these clinical studies, the triple combination therapy is now available as a prescription medication for treating asthma in adults in the USA, Japan, Australia, Canada and other countries. It is the first once-daily triple therapy available in a single inhaler for adults with asthma.
The ARIA study aims to provide important information on whether the favorable profile of FF/UMEC/VI demonstrated in adult asthma patients extends to the adolescent age group.
Study Dates:
April 1, 2023 - June 1, 2026
Type of Study:
Pre-Market
Study Design:
Controlled Design
Study Location:
Nationwide
Lead Institution:
Multiple sites
Funding Source:
GSK
ClinicalTrails.gov Identifier:
NCT05757102
