Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA… (NCT06372496) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma
United States1,366 participantsStarted 2024-04-16
Plain-language summary
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
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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
✕. Recent history of life-threatening asthma
✕. History of \>1 severe exacerbation of asthma within 12 months prior to randomization.
✕. Women of childbearing potential that are not following at least one highly effective method of contraception. This includes women who are pregnant or lactating or are planning on becoming pregnant during the study.
✕. A WOCBP must have a negative pregnancy test ≤7 days prior to randomization.
✕. Exposure to inhaler triple therapy \[ICS + Long-acting muscarinic antagonist (LAMA) + LABA as Single inhaler triple therapy (SITT) or Multiple inhaler triple therapy(MITT)\] and/or any LAMA-containing therapy within 12 months prior to randomization.
✕. Ongoing need for biologic therapy or recent use of a biologic therapy
What they're measuring
1
Change from baseline in trough forced expiratory volume in 1 second (FEV1)
. Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines.
✕. Participants whose current medications include RELVAR ELLIPTA and ARNUITY ELLIPTA are not eligible to enter the study.