Clinical trial NCT06372496: Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
FF/UMEC/VI
ICS/LABA
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2024-04-18
Enrollment: 1358
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Has a diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2023 guidelines for at least 3 months prior to randomization.
2. Participants who are either:

   * Currently untreated
   * Treated with daily maintenance ICS or ICS/LABA
3. ACQ-6 score ≥1.5 at randomization.
4. 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)
5. Participants must be able to complete the study questionnaires.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

1. Recent history of life-threatening asthma
2. History of \>1 severe exacerbation of asthma within 12 months prior to randomization.
3. 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.
4. A WOCBP must have a negative pregnancy test ≤7 days prior to randomization.
5. 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.
6. Ongoing need for biologic therapy or recent use of a biologic therapy
7. Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines.
8. Participants whose current medications include RELVAR ELLIPTA and ARNUITY ELLIPTA are not eligible to enter the study.
9. Participants who are medically unable to withhold their albuterol/salbutamol for 6 hours prior to spirometry testing
10. Changes in asthma medication (e.g., maintenance ICS/LABA) within 3 months prior to randomization.
11. Participants with a history of hypersensitivity to any of the study medications

Primary outcomes:
measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1)
timeFrame: Baseline (Day 1), and at Week 24
Secondary outcomes:
measure: Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-7 (ACQ-7) after 24 weeks of treatment
timeFrame: Baseline (Day 1), and Week 24
measure: Number of participants achieving the composite endpoint (optimized) after 52 weeks of treatment
timeFrame: Up to 52 weeks
measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) after 52 weeks of treatment
timeFrame: Baseline (Day 1), and Week 52
measure: Change from baseline in trough FEV1 ≥ 100mL after 24 and 52 weeks of treatment
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change from baseline in through FEV1 ≥ 0mL after 24 and 52 weeks of treatment
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-7 after 52 weeks of treatment
timeFrame: Week 52
measure: 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
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-5 after 24 and 52 weeks of treatment
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change from baseline in the ACQ-7 total score after 24 and 52 weeks of treatment
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change from baseline in the ACQ-5 total score after 24 and 52 weeks of treatment
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change from baseline in the ACQ-6 total score after 24 and 52 weeks of treatment
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change from baseline in the Asthma Control Test (ACT) score after 24 and 52 weeks of treatment
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Number of participants achieving the composite endpoint among those on ICS/LABA prior to randomization
timeFrame: Week 52
measure: Number of participants achieving the composite endpoint among those on no treatment prior to randomization
timeFrame: Up to 52 weeks
measure: Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) total scores after 24 and 52 weeks of treatment
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) domain scores after 24 and 52 weeks of treatment
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: 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
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) among participants on budesonide/formoterol prior to randomization
timeFrame: Baseline (Day 1), and Week 24
measure: Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 among participants on ICS/LABA prior to randomization
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change from baseline in the ACQ-7 total score among participants on ICS/LABA prior to randomization
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) for participants with no treatment prior to randomization.
timeFrame: Baseline (Day 1), and Week 24
measure: Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 for participants with no treatment prior to randomization.
timeFrame: Baseline (Day 1), Week 24 and Week 52
measure: Change from baseline in the ACQ-7 total score for participants with no treatment prior to randomization.
timeFrame: Baseline (Day 1), Week 24 and Week 52
Other outcomes:
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state: Texas
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country: Argentina
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country: Argentina
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city: Ciudad AutOnoma de Buenos Aires
country: Argentina
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country: Argentina
facility: GSK Investigational Site
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country: Argentina
facility: GSK Investigational Site
city: Mendoza
country: Argentina
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city: Quilmes
country: Argentina
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city: Rosario
country: Argentina
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city: Rosario
country: Argentina
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city: Bruce
country: Australia
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state: Australian Capital Territory
city: Blacktown
country: Australia
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city: Coffs Harbour
country: Australia
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state: New South Wales
city: Kanwal
country: Australia
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state: New South Wales
city: Sydney
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state: New South Wales
city: Brisbane
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city: Okawa-shi
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
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city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Yokohama-shi
country: Japan
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Kaohsiung
country: Taiwan
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city: Taichung
country: Taiwan
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Study officials:
References: