A Phase 4, 52-week (Primary Analysis at 24-weeks), Randomized, Stratified, Open-label, Active-controlled, Parallel-group, Effectiveness Study, Comparing FF/UMEC/VI With Non-ellipta Usual Care (ICS/LABA) in Adult Participants With Uncontrolled Asthma
A Phase 4, 52-week (Primary Analysis at 24-weeks), Randomized, Stratified, Open-label, Active-controlled, Parallel-group, Effectiveness Study, Comparing FF/UMEC/VI With Non-ellipta Usual Care (ICS/LABA) in Adult Participants With Uncontrolled Asthma
The goal of this study is to assess and compare the effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) with inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) in adult participants with uncontrolled asthma
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
Has a diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2023 guidelines for at least 3 months prior to randomization.
Participants who are either:
ACQ-6 score ≥1.5 at randomization.
Participants able to perform technically acceptable and repeatable FEV1 maneuvers (i.e., a minimum of 2 acceptable and 1 repeatable effort) at visit 2 (V2)
Participants must be able to complete the study questionnaires.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Ciudad Autonoma de Buenos Aire, 1012, Argentina
Chancheng District, Foshan City 528031, China
Liwan District, Guangzhou 510160, China
North Street, Jiangmen City 52900, China
Nagaoka-Shi, 940-0087, Japan
Okawa-shi, 831-0016, Japan
Shinjuku-kuTokyo, 160-0021, Japan
Seongnam-si Gyeonggi-do, 13620, South Korea
Suwon Kyunggi-do, 16499, South Korea