Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma (PERFORM)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate; Drug: Inhaled corticosteroids/long-acting beta-2 agonists

• Study Type: Interventional
• Enrollment (Actual): 1366
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425BEN
    • GSK Investigational Site
  • Buenos Aires, Argentina, C1128AAF
    • GSK Investigational Site
  • Buenos Aires, Argentina, C1192AAW
    • GSK Investigational Site
  • Buenos Aires, Argentina, FVH1425
    • GSK Investigational Site
  • Ciudad Autonoma de Buenos Aire, Argentina, 1012
    • GSK Investigational Site
  • Concepción del Uruguay, Argentina, 3260
    • GSK Investigational Site
  • Córdoba, Argentina, X5003DCE
    • GSK Investigational Site
  • Formosa, Argentina, 3600
    • GSK Investigational Site
  • Luján, Argentina, 6700
    • GSK Investigational Site
  • Luján de Cuyo, Argentina, 5509
    • GSK Investigational Site
  • Mar del Plata, Argentina, 7600
    • GSK Investigational Site
  • Mendoza, Argentina, 5500
    • GSK Investigational Site
  • Mendoza, Argentina, 5577
    • GSK Investigational Site
  • Mendoza, Argentina, M5500
    • GSK Investigational Site
  • Quilmes, Argentina, 1878
    • GSK Investigational Site
  • Rosario, Argentina, 2000
    • GSK Investigational Site
  • Rosario, Argentina, S2000DBS
    • GSK Investigational Site
  • Rosario, Argentina, S2000 DEJ
    • GSK Investigational Site
  • San Juan Bautista, Argentina, 1888
    • GSK Investigational Site
  • San Miguel de Tucumán, Argentina, T4000AXL
    • GSK Investigational Site
  • Santa Fe, Argentina, 3000
    • GSK Investigational Site
• Australia
  • Australian Capital Territory
    • Bruce, Australian Capital Territory, Australia, 2617
      • GSK Investigational Site
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • GSK Investigational Site
    • Coffs Harbour, New South Wales, Australia, 2450
      • GSK Investigational Site
    • Kanwal, New South Wales, Australia, 2259
      • GSK Investigational Site
    • Sydney, New South Wales, Australia, 2035
      • GSK Investigational Site
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • GSK Investigational Site
  • Western Australia
    • Osborne Park, Western Australia, Australia, 6017
      • GSK Investigational Site
    • Spearwood, Western Australia, Australia, 6163
      • GSK Investigational Site
• Canada
  • Ontario
    • Windsor, Ontario, Canada, N8X 1T3
      • GSK Investigational Site
  • Quebec
    • Trois-Rivières, Quebec, Canada, G9A 4P3
      • GSK Investigational Site
• China
  • Nanshan District, China, 518067
    • GSK Investigational Site
  • Zhuhai, China, 519099
    • GSK Investigational Site
  • Foshan City
    • Chancheng District, Foshan City, China, 528031
      • GSK Investigational Site
  • Guangzhou
    • Liwan District, Guangzhou, China, 510160
      • GSK Investigational Site
  • Jiangmen City
    • North Street, Jiangmen City, China, 52900
      • GSK Investigational Site
• Japan
  • Fukuoka, Japan, 807-8555
    • GSK Investigational Site
  • Fukuoka, Japan, 820-8505
    • GSK Investigational Site
  • Fukuoka, Japan, 816-0813
    • GSK Investigational Site
  • Fukuoka, Japan, 832-0059
    • GSK Investigational Site
  • Fukuoka, Japan, 802-0083
    • GSK Investigational Site
  • Gifu, Japan, 509-6134
    • GSK Investigational Site
  • Hiroshima, Japan, 730-0853
    • GSK Investigational Site
  • Hiroshima, Japan, 730-0013
    • GSK Investigational Site
  • Hiroshima, Japan, 733-0002
    • GSK Investigational Site
  • Hyōgo, Japan, 651-0053
    • GSK Investigational Site
  • Kagawa, Japan, 761-8073
    • GSK Investigational Site
  • Kagoshima, Japan, 890-0053
    • GSK Investigational Site
  • Kanagawa, Japan, 252-0143
    • GSK Investigational Site
  • Kumamoto, Japan, 860-8556
    • GSK Investigational Site
  • Kumamoto, Japan, 862-0965
    • GSK Investigational Site
  • Matsuyama, Japan, 790-0925
    • GSK Investigational Site
  • Miyagi, Japan, 980-0871
    • GSK Investigational Site
  • Miyazaki, Japan, 880-2112
    • GSK Investigational Site
  • Miyazaki, Japan, 889-4304
    • GSK Investigational Site
  • Nagaoka-Shi, Japan, 940-0087
    • GSK Investigational Site
  • Niigata, Japan, 950-0088
    • GSK Investigational Site
  • Okawa-shi, Japan, 831-0016
    • GSK Investigational Site
  • Shinjuku-kuTokyo, Japan, 160-0021
    • GSK Investigational Site
  • Tokyo, Japan, 160-0017
    • GSK Investigational Site
  • Tokyo, Japan, 142-8666
    • GSK Investigational Site
  • Tokyo, Japan, 157-0066
    • GSK Investigational Site
  • Tokyo, Japan, 173-8606
    • GSK Investigational Site
  • Tokyo, Japan, 145-0063
    • GSK Investigational Site
  • Tokyo, Japan, 105-0001
    • GSK Investigational Site
  • Yokohama, Japan, 223-0053
    • GSK Investigational Site
  • Ōita, Japan
    • GSK Investigational Site
• South Korea
  • Busan, South Korea, 602 702
    • GSK Investigational Site
  • Daegu, South Korea, 41404
    • GSK Investigational Site
  • Seongnam-si Gyeonggi-do, South Korea, 13620
    • GSK Investigational Site
  • Seoul, South Korea, 03080
    • GSK Investigational Site
  • Seoul, South Korea, 02841
    • GSK Investigational Site
  • Seoul, South Korea, 133-792
    • GSK Investigational Site
  • Seoul, South Korea, 158-710
    • GSK Investigational Site
  • Seoul, South Korea, 07061
    • GSK Investigational Site
  • Seoul, South Korea, 5030
    • GSK Investigational Site
  • Suwon Kyunggi-do, South Korea, 16499
    • GSK Investigational Site
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • GSK Investigational Site
  • Taichung, Taiwan, 40447
    • GSK Investigational Site
  • Taichung, Taiwan, 407219
    • GSK Investigational Site
  • Taipei, Taiwan, 10002
    • GSK Investigational Site
• United States
  • Alabama
    • Centreville, Alabama, United States, 35042
      • GSK Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • GSK Investigational Site
  • California
    • Newport Beach, California, United States, 92663
      • GSK Investigational Site
  • Delaware
    • Newark, Delaware, United States, 08901
      • GSK Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33765-2150
      • GSK Investigational Site
    • Florida City, Florida, United States, 32819
      • GSK Investigational Site
    • Miami, Florida, United States, 33173
      • GSK Investigational Site
    • Miami, Florida, United States, 33126
      • GSK Investigational Site
    • Miami, Florida, United States, 33135
      • GSK Investigational Site
    • Miami, Florida, United States, 15801
      • GSK Investigational Site
    • North Miami Beach, Florida, United States, 33169
      • GSK Investigational Site
    • Palm Springs, Florida, United States, 33406
      • GSK Investigational Site
    • Port Charlotte, Florida, United States, 33952
      • GSK Investigational Site
    • Tallahassee, Florida, United States, 32308
      • GSK Investigational Site
  • Illinois
    • Normal, Illinois, United States, 61761
      • GSK Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 20852
      • GSK Investigational Site
  • Maine
    • Bangor, Maine, United States, 04401
      • GSK Investigational Site
  • Michigan
    • Detroit, Michigan, United States, 48202
      • GSK Investigational Site
    • Warren, Michigan, United States, 48088
      • GSK Investigational Site
  • Montana
    • Missoula, Montana, United States, 59804
      • GSK Investigational Site
  • Nebraska
    • Papillion, Nebraska, United States, 68046
      • GSK Investigational Site
  • New Jersey
    • Brick, New Jersey, United States, 08724
      • GSK Investigational Site
    • Linwood, New Jersey, United States, 08221
      • GSK Investigational Site
  • New York
    • New Windsor, New York, United States, 12553
      • GSK Investigational Site
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • GSK Investigational Site
    • Charlotte, North Carolina, United States, 28273
      • GSK Investigational Site
    • Greenville, North Carolina, United States, 27834
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27104
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15241
      • GSK Investigational Site
  • South Carolina
    • Rock Hill, South Carolina, United States, 29732
      • GSK Investigational Site
    • Spartanburg, South Carolina, United States, 29303
      • GSK Investigational Site
  • Texas
    • Beaumont, Texas, United States, 77701
      • GSK Investigational Site
    • Dallas, Texas, United States, 75225
      • GSK Investigational Site
  • Washington
    • Bellingham, Washington, United States, 98225
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI)	Drug: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate; Participants will receive FF/UMEC/VI
Active Comparator: Inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA)	Drug: Inhaled corticosteroids/long-acting beta-2 agonists; Participants will receive ICS/LABA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in trough forced expiratory volume in 1 second (FEV1)	Baseline (Day 1), and at Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-7 (ACQ-7) after 24 weeks of treatment	The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation).Higher scores indicate greater impairment. ACQ-7 is the responder analysis based on a 0.5 point change.	Baseline (Day 1), and Week 24
Change from baseline in trough forced expiratory volume in 1 second (FEV1) after 52 weeks of treatment		Baseline (Day 1), and Week 52
Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-7 after 52 weeks of treatment	The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment. ACQ-7 is the responder analysis based on a 0.5 point change.	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	The ACQ-6 is a shortened version of the ACQ-7 derived by removing one element (lung function element) from the original version. The scoring ranges from 0 (no impairment/ limitation) to 6 (total impairment/ limitation), higher scores indicate greater impairment. ACQ-6 is the responder analysis based on a 0.5 point change.	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	The ACQ-5 consists of 5 questions scored from zero (no impairment/limitation) to six (total impairment/ limitation). Higher scores indicate greater impairment. It is a shorter version of ACQ-7 derived by removal of two elements (lung function and rescue use elements) from original version (ACQ-7). ACQ-5 is the responder analysis based on a 0.5 point change.	Baseline (Day 1), Week 24 and Week 52
Change from baseline in the ACQ-7 total score after 24 and 52 weeks of treatment	The ACQ-7 total consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment.	Baseline (Day 1), Week 24 and Week 52
Change from baseline in the ACQ-5 total score after 24 and 52 weeks of treatment	The ACQ-5 total consists of 5 questions scored from zero (no impairment/limitation) to six (total impairment/ limitation). Higher scores indicate greater impairment. It is a shorter version of ACQ-7 derived by removal of two elements (lung function and rescue use elements) from original version (ACQ-7).	Baseline (Day 1), Week 24 and Week 52
Change from baseline in the ACQ-6 total score after 24 and 52 weeks of treatment	The ACQ-6 total is a shortened version of the ACQ-7 derived by removing one element (lung function element) from the original version. The scoring ranges from 0 (no impairment/limitation) to 6 (total impairment/ limitation), higher scores indicate greater impairment.	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	The ACT is a 5-question health survey used to measure asthma control in participants aged ≥12 years. Each question is scored from 1 to 5 for a total score ranging from 5 to 25; with higher scores indicating better asthma control.	Baseline (Day 1), Week 24 and Week 52
Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) total scores after 24 and 52 weeks of treatment	The AQLQ (+12), is a modified version of the original AQLQ with standardized activities. The response scale ranges from 1 (totally impaired) to 7 (not at all impaired). The total score is the score from all 32 questions.	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	The AQLQ (+12), is a modified version of the original AQLQ with standardized activities. The response scale ranges from 1 (totally impaired) to 7 (not at all impaired). The domain score looks at each domain individually - symptoms, activity limitation, emotional function and environmental stimuli.	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	WPAI is a self-administered tool to determine the degree to which asthma affected work productivity while at work and affected activities outside of work in the last 7 days. The WPAI questionnaire score represents the percentage of impairment, from 0 to 100%. Higher WPAI scores indicate greater activity impairment.	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
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.	The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment. ACQ-7 is the responder analysis based on a 0.5 point change.	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.	The ACQ-7 total consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment. s	Baseline (Day 1), Week 24 and Week 52
Number of participants achieving the composite endpoint (optimized) after 52 weeks of treatment	The 4-point composite endpoint is defined as meeting the following criteria: Change from baseline in trough FEV1 ≥ 100 mL at Week 52.; Controlled asthma based on ACQ-5 total score ≤ 1.5 at Week 52.; No severe asthma exacerbations over 52 weeks.; OCS-free over 52 weeks	Up to 52 weeks
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 the composite endpoint among those on ICS/LABA prior to randomization	The 4-point composite endpoint is defined as meeting the following criteria: Change from baseline in trough FEV1 ≥ 100 mL at Week 52; Controlled asthma based on ACQ-5 total score ≤ 1.5 at Week 52; No severe asthma exacerbations over 52 weeks; OCS-free over 52 weeks	Week 52
Number of participants achieving the composite endpoint among those on no treatment prior to randomization	The 4-point composite endpoint is defined as meeting the following criteria: Change from baseline in trough FEV1 ≥ 100 mL at Week 52.; Controlled asthma based on ACQ-5 total score ≤ 1.5 at Week 52.; No severe asthma exacerbations over 52 weeks.; OCS-free over 52 weeks	Up to 52 weeks
Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 among participants on ICS/LABA prior to randomization	The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment. ACQ-7 is the responder analysis based on a 0.5 point change.	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	The ACQ-7 total consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment.	Baseline (Day 1), Week 24 and Week 52

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Actual): July 28, 2025
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; ICS/LABA; FF/UMEC/VI
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Physiological Effects of Drugs; Anti-Inflammatory Agents; Autonomic Agents; Peripheral Nervous System Agents; Dermatologic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Anti-Allergic Agents; Anticonvulsants; fluticasone furoate
• Other Study ID Numbers: 219912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
• IPD Sharing Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• IPD Sharing Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No