Last updated: 07/27/2026 16:20:58
Pragmatic open - label randomized clinical trial of FF/UMEC/VI vs non-ellipta usual care ICS-LABA for adult participants with uncontrolled asthmaPERFORM
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Active, not recruiting
Active, not recruiting
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 (CFB) in trough forced expiratory volume in 1 second (FEV1) at Week 24
Timeframe: Baseline (Day 1) and at Week 24
Secondary outcomes:
Percentage of participants achieving greater than equal to (>=) 0.5 point improvement (decrease) from Baseline for the Asthma Control Questionnaire-7 (ACQ-7) at Week 24
Timeframe: Baseline (Day 1) and at Week 24
Percentage of participants achieving the composite endpoint (optimized) at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Change from Baseline in trough forced expiratory volume in 1 second (FEV1) at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Percentage of Participants with Change from Baseline in trough FEV1 >= 100 mL at Week 24
Timeframe: Baseline (Day 1) and at Week 24
Percentage of Participants with Change from Baseline in trough FEV1 >= 100 mL at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Percentage of Participants with Change from Baseline in trough FEV1 >= 0 mL at Week 24
Timeframe: Baseline (Day 1) and at Week 24
Percentage of Participants with Change from Baseline in trough FEV1 >= 0 mL at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Percentage of Participants achieving >= 0.5 point improvement (decrease) from Baseline for the ACQ-7 score at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Percentage of Participants achieving >=0.5 point improvement (decrease) from Baseline for the ACQ-6 score at Week 24
Timeframe: Baseline (Day 1) and at Week 24
Percentage of Participants achieving >=0.5 point improvement (decrease) from baseline for the ACQ-6 score at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Percentage of Participants achieving >=0.5 point improvement (decrease) from Baseline for the ACQ-5 score at Week 24
Timeframe: Baseline (Day 1) and at Week 24
Percentage of Participants achieving >=0.5 point improvement (decrease) from Baseline for the ACQ-5 at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Change from Baseline (CFB) in the ACQ-7 total score at Week 24
Timeframe: Baseline (Day 1) and at Week 24
Change from Baseline (CFB) in the ACQ-7 total score at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Change from Baseline (CFB) in the ACQ-6 total score at Week 24
Timeframe: Baseline (Day 1) and at Week 24
Change from Baseline (CFB) in the ACQ-6 total score at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Change from Baseline (CFB) in the ACQ-5 total score at Week 24
Timeframe: Baseline (Day 1) and at Week 24
Change from Baseline (CFB) in the ACQ-5 total score at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Change from Baseline (CFB) in the Asthma Control Test (ACT) score at Week 24
Timeframe: Baseline (Day 1) and at Week 24
Change from Baseline (CFB) in the Asthma Control Test (ACT) score at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Percentage of participants achieving the composite endpoint (optimized) subset on participants receiving ICS/LABA prior to randomization at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Percentage of participants achieving the composite endpoint (optimized) subset on participants receiving no treatment prior to randomization at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Change from Baseline (CFB) in the Asthma Quality of Life Questionnaire (AQLQ-12) total score at Week 24
Timeframe: Baseline (Day 1) and at Week 24
Change from Baseline (CFB) in the Asthma Quality of Life Questionnaire (AQLQ-12) total score at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Change from Baseline (CFB) in the Asthma Quality of Life Questionnaire (AQLQ-12) domain score at Week 24
Timeframe: Baseline (Day 1) and at Week 24
Change from Baseline (CFB) in the Asthma Quality of Life Questionnaire (AQLQ-12) domain score at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Change from Baseline (CFB) in the four domains of the asthma-specific adaptation of the Work Productivity and Activity Impairment (WPAI) Questionnaire at Week 24
Timeframe: Baseline (Day 1) and at Week 24
Change from Baseline in the four domains of the asthma-specific adaptation of the Work Productivity and Activity Impairment Questionnaire at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Change from Baseline in trough forced expiratory volume in 1 second (FEV1) at Week 24 among participants on ICS/LABA prior to randomization
Timeframe: Baseline (Day 1) and Week 24
Percentage of participants achieving >=0.5 points improvement (decrease) from Baseline for ACQ-7 at Week 24 among participants on ICS/LABA prior to randomization
Timeframe: Baseline (Day 1) and at Week 24
Percentage of participants achieving >=0.5 points improvement (decrease) from Baseline for ACQ-7 at Week 52 among participants on ICS/LABA prior to randomization
Timeframe: Baseline (Day 1) and at Week 52
Change from Baseline in the ACQ-7 total score at Week 24 among participants on ICS/LABA prior to randomization
Timeframe: Baseline (Day 1) and at Week 24
Change from Baseline (CFB) in the ACQ-7 total score at Week 52 among participants on ICS/LABA prior to randomization
Timeframe: Baseline (Day 1) and at Week 52
Change from Baseline in trough forced expiratory volume in 1 second (FEV1) at Week 24 for participants with no treatment prior to randomization
Timeframe: Baseline (Day 1) and Week 24
Percentage of participants achieving >=0.5 points improvement (decrease) from Baseline for ACQ-7 at Week 24 for participants with no treatment prior to randomization.
Timeframe: Baseline (Day 1) and at Week 24
Percentage of participants achieving >=0.5 points improvement (decrease) from Baseline for ACQ-7 at Week 52 for participants with no treatment prior to randomization
Timeframe: Baseline (Day 1) and at Week 52
Change from baseline (CFB) in the ACQ-7 total score at Week 24 for participants with no treatment prior to randomization
Timeframe: Baseline (Day 1) and at Week 24
Change from baseline (CFB) in the ACQ-7 total score at Week 52 for participants with no treatment prior to randomization
Timeframe: Baseline (Day 1) and at Week 52
Interventions:
Drug: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate
Drug: Inhaled corticosteroids/long-acting beta-2 agonists
Enrollment:
1358
Observational study model:
Not applicable
Primary completion date:
2025-28-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
April 2024 to June 2027
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
Linwood, New Jersey, United States, 08221
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, PA, United States, 19140
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1128AAF
Status
Study Complete
Location
GSK Investigational Site
Ciudad AutOnoma de Buenos Aires, Argentina, C1192AAW
Status
Unmapped
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina, 1012
Status
Unmapped
Location
GSK Investigational Site
Clearwater, FL, United States, 33765-2150
Status
Study Complete
Location
GSK Investigational Site
Chancheng District, Foshan City, China, 528031
Status
Unmapped
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Active, not recruiting
Actual primary completion date
2025-28-07
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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