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

GlaxoSmithKline118 个研究点分布在 3 个国家目标入组 1,366 人2024年4月16日

适应症Asthma

干预措施Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate Inhaled corticosteroids/long-acting beta-2 agonists

概览

阶段: 4 期
干预措施: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate
疾病 / 适应症: Asthma
发起方: GlaxoSmithKline
入组人数: 1366
试验地点: 118
主要终点: Change from baseline in trough forced expiratory volume in 1 second (FEV1)
状态: 进行中（未招募）
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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

注册库

clinicaltrials.gov

开始日期

2024年4月16日

结束日期

2027年3月31日

最后更新

上个月

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

GlaxoSmithKline

责任方

Sponsor

入排标准

入选标准

•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:
•Currently untreated
•Treated with daily maintenance ICS or ICS/LABA
•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.

排除标准

•Participants are excluded from the study if any of the following criteria apply:
•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
•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.
•Participants who are medically unable to withhold their albuterol/salbutamol for 6 hours prior to spirometry testing

研究组 & 干预措施

Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI)

干预措施: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate

Inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA)

干预措施: Inhaled corticosteroids/long-acting beta-2 agonists

结局指标

主要结局

Change from baseline in trough forced expiratory volume in 1 second (FEV1)

时间窗: Baseline (Day 1), and at Week 24

次要结局

Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-7 (ACQ-7) after 24 weeks of treatment(Baseline (Day 1), and Week 24)
Number of participants achieving the composite endpoint (optimized) after 52 weeks of treatment(Up to 52 weeks)
Change from baseline in trough forced expiratory volume in 1 second (FEV1) after 52 weeks of treatment(Baseline (Day 1), and Week 52)
Change from baseline in trough FEV1 ≥ 100mL after 24 and 52 weeks of treatment(Baseline (Day 1), Week 24 and Week 52)
Change from baseline in through FEV1 ≥ 0mL after 24 and 52 weeks of treatment(Baseline (Day 1), Week 24 and Week 52)
Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-7 after 52 weeks of treatment(Week 52)
Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-6 (ACQ-6) after 24 and 52 weeks of treatment(Baseline (Day 1), Week 24 and Week 52)
Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-5 after 24 and 52 weeks of treatment(Baseline (Day 1), Week 24 and Week 52)
Change from baseline in the ACQ-7 total score after 24 and 52 weeks of treatment(Baseline (Day 1), Week 24 and Week 52)
Change from baseline in the ACQ-5 total score after 24 and 52 weeks of treatment(Baseline (Day 1), Week 24 and Week 52)
Change from baseline in the ACQ-6 total score after 24 and 52 weeks of treatment(Baseline (Day 1), Week 24 and Week 52)
Change from baseline in the Asthma Control Test (ACT) score after 24 and 52 weeks of treatment(Baseline (Day 1), Week 24 and Week 52)
Number of participants achieving the composite endpoint among those on ICS/LABA prior to randomization(Week 52)
Number of participants achieving the composite endpoint among those on no treatment prior to randomization(Up to 52 weeks)
Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) total scores after 24 and 52 weeks of treatment(Baseline (Day 1), Week 24 and Week 52)
Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) domain scores after 24 and 52 weeks of treatment(Baseline (Day 1), Week 24 and Week 52)
Change from baseline in the four domains of the asthma-specific adaptation of the Work Productivity and Activity Impairment Questionnaire (WPAI:Asthma) after 24 and 52 weeks of treatment(Baseline (Day 1), Week 24 and Week 52)
Change from baseline in trough forced expiratory volume in 1 second (FEV1) among participants on budesonide/formoterol prior to randomization(Baseline (Day 1), and Week 24)
Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 among participants on ICS/LABA prior to randomization(Baseline (Day 1), Week 24 and Week 52)
Change from baseline in the ACQ-7 total score among participants on ICS/LABA prior to randomization(Baseline (Day 1), Week 24 and Week 52)
Change from baseline in trough forced expiratory volume in 1 second (FEV1) for participants with no treatment prior to randomization.(Baseline (Day 1), and Week 24)
Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 for participants with no treatment prior to randomization.(Baseline (Day 1), Week 24 and Week 52)
Change from baseline in the ACQ-7 total score for participants with no treatment prior to randomization.(Baseline (Day 1), Week 24 and Week 52)