Last updated: 10/21/2025 03:00:35
Pragmatic open - label randomized clinical trial of FF/UMEC/VI vs non-ellipta usual care ICS-LABA for adult participants with uncontrolled asthmaPERFORM
GSK study ID
219912
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Change from baseline in trough forced expiratory volume in 1 second (FEV1)
Timeframe: Baseline (Day 1), and at Week 24
Secondary outcomes:
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
Number of participants achieving the composite endpoint (optimized) after 52 weeks of treatment
Timeframe: Up to 52 weeks
Change from baseline in trough forced expiratory volume in 1 second (FEV1) after 52 weeks of treatment
Timeframe: Baseline (Day 1), and Week 52
Change from baseline in trough FEV1 ≥ 100mL after 24 and 52 weeks of treatment
Timeframe: Baseline (Day 1), Week 24 and Week 52
Change from baseline in through FEV1 ≥ 0mL after 24 and 52 weeks of treatment
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Baseline (Day 1), Week 24 and Week 52
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
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
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
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
Number of participants achieving the composite endpoint among those on ICS/LABA prior to randomization
Timeframe: Week 52
Number of participants achieving the composite endpoint among those on no treatment prior to randomization
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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.
Timeframe: 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.
Timeframe: 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.
Timeframe: Baseline (Day 1), Week 24 and Week 52
Interventions:
Enrollment:
1357
Primary completion date:
2025-08-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
April 2024 to January 2026
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 75 Years
Accepts healthy volunteers
No
- 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.
- Participants are excluded from the study if any of the following criteria apply:
- 1) Recent history of life-threatening asthma
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Bangor, ME, United States, 04401
Status
Recruitment Complete
Location
GSK Investigational Site
Linwood, New Jersey, United States, 08221
Status
Recruitment Complete
Location
GSK Investigational Site
Little Rock, AR, United States, 72205
Status
Recruitment Complete
Location
GSK Investigational Site
Newport Beach, CA, United States, 92663
Status
Recruitment Complete
Location
GSK Investigational Site
Orlando, FL, United States, 32819
Status
Recruitment Complete
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Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruitment complete
Actual primary completion date
2025-08-09
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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