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

NCT06372496 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 219912
• Study Type: interventional
• Target: 1,366
• Locations: 8 countries
• Sites: 117

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

Conditions

Asthma

Keywords

Asthma; FF/UMEC/VI; ICS/LABA

Outcome Measures

Primary Outcomes (1)

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

  Baseline (Day 1), and at Week 24

Secondary Outcomes (23)

• 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

Study Arms (2)

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

EXPERIMENTAL

Drug: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate

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

ACTIVE COMPARATOR

Drug: Inhaled corticosteroids/long-acting beta-2 agonists

Interventions

Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate DRUG

Participants will receive FF/UMEC/VI

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

Inhaled corticosteroids/long-acting beta-2 agonists DRUG

Participants will receive ICS/LABA

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Changes in asthma medication (e.g., maintenance ICS/LABA) within 3 months prior to randomization.
• Participants with a history of hypersensitivity to any of the study medications

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (117)

GSK Investigational Site

Centreville, Alabama, 35042, United States

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Little Rock, Arkansas, 72205, United States

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Newport Beach, California, 92663, United States

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Newark, Delaware, 08901, United States

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Clearwater, Florida, 33765-2150, United States

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Florida City, Florida, 32819, United States

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Miami, Florida, 15801, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33135, United States

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Miami, Florida, 33173, United States

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North Miami Beach, Florida, 33169, United States

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Palm Springs, Florida, 33406, United States

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Port Charlotte, Florida, 33952, United States

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Tallahassee, Florida, 32308, United States

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Normal, Illinois, 61761, United States

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New Orleans, Louisiana, 20852, United States

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Bangor, Maine, 04401, United States

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Detroit, Michigan, 48202, United States

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Warren, Michigan, 48088, United States

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Missoula, Montana, 59804, United States

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Papillion, Nebraska, 68046, United States

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Brick, New Jersey, 08724, United States

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Linwood, New Jersey, 08221, United States

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New Windsor, New York, 12553, United States

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Asheville, North Carolina, 28801, United States

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Charlotte, North Carolina, 28273, United States

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Greenville, North Carolina, 27834, United States

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Winston-Salem, North Carolina, 27104, United States

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Cincinnati, Ohio, 45231, United States

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Philadelphia, Pennsylvania, 19140, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Rock Hill, South Carolina, 29732, United States

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Spartanburg, South Carolina, 29303, United States

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Beaumont, Texas, 77701, United States

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Dallas, Texas, 75225, United States

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Bellingham, Washington, 98225, United States

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Buenos Aires, C1128AAF, Argentina

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Buenos Aires, C1192AAW, Argentina

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Buenos Aires, C1425BEN, Argentina

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Buenos Aires, FVH1425, Argentina

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Ciudad Autonoma de Buenos Aire, 1012, Argentina

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Concepción del Uruguay, 3260, Argentina

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Córdoba, X5003DCE, Argentina

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Formosa, 3600, Argentina

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Luján, 6700, Argentina

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Luján de Cuyo, 5509, Argentina

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Mar del Plata, 7600, Argentina

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Mendoza, 5500, Argentina

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Mendoza, 5577, Argentina

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Mendoza, M5500, Argentina

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Quilmes, 1878, Argentina

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Rosario, 2000, Argentina

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Rosario, S2000 DEJ, Argentina

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Rosario, S2000DBS, Argentina

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San Juan Bautista, 1888, Argentina

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San Miguel de Tucumán, T4000AXL, Argentina

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Santa Fe, 3000, Argentina

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Bruce, Australian Capital Territory, 2617, Australia

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Blacktown, New South Wales, 2148, Australia

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Coffs Harbour, New South Wales, 2450, Australia

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Kanwal, New South Wales, 2259, Australia

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Sydney, New South Wales, 2035, Australia

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Brisbane, Queensland, 4006, Australia

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Osborne Park, Western Australia, 6017, Australia

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Spearwood, Western Australia, 6163, Australia

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Windsor, Ontario, N8X 1T3, Canada

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Trois-Rivières, Quebec, G9A 4P3, Canada

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Chancheng District, Foshan City, 528031, China

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Liwan District, Guangzhou, 510160, China

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North Street, Jiangmen City, 52900, China

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Nanshan District, 518067, China

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Zhuhai, 519099, China

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Fukuoka, 802-0083, Japan

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Fukuoka, 807-8555, Japan

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Fukuoka, 816-0813, Japan

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Fukuoka, 820-8505, Japan

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Fukuoka, 832-0059, Japan

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Gifu, 509-6134, Japan

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Hiroshima, 730-0013, Japan

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Hiroshima, 730-0853, Japan

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Hiroshima, 733-0002, Japan

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Hyōgo, 651-0053, Japan

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Kagawa, 761-8073, Japan

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Kagoshima, 890-0053, Japan

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Kanagawa, 252-0143, Japan

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Kumamoto, 860-8556, Japan

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Kumamoto, 862-0965, Japan

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Matsuyama, 790-0925, Japan

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Miyagi, 980-0871, Japan

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Miyazaki, 880-2112, Japan

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Miyazaki, 889-4304, Japan

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Nagaoka-Shi, 940-0087, Japan

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Niigata, 950-0088, Japan

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Okawa-shi, 831-0016, Japan

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Ōita, Japan

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Shinjuku-kuTokyo, 160-0021, Japan

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Tokyo, 105-0001, Japan

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Tokyo, 142-8666, Japan

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Tokyo, 145-0063, Japan

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Tokyo, 157-0066, Japan

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Tokyo, 160-0017, Japan

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Tokyo, 173-8606, Japan

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Yokohama, 223-0053, Japan

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Busan, 602 702, South Korea

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Daegu, 41404, South Korea

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Seongnam-si Gyeonggi-do, 13620, South Korea

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Seoul, 02841, South Korea

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GSK Investigational Site

Seoul, 03080, South Korea

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GSK Investigational Site

Seoul, 07061, South Korea

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Seoul, 133-792, South Korea

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Seoul, 158-710, South Korea

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GSK Investigational Site

Seoul, 5030, South Korea

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GSK Investigational Site

Suwon Kyunggi-do, 16499, South Korea

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Kaohsiung City, 807, Taiwan

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GSK Investigational Site

Taichung, 40447, Taiwan

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GSK Investigational Site

Taichung, 407219, Taiwan

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GSK Investigational Site

Taipei, 10002, Taiwan

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MeSH Terms

Conditions

Asthma

Interventions

fluticasone furoate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: April 16, 2024
• Primary Completion: July 28, 2025
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

CN (5); AU (8); CA (2); US (36); JP (31); AR (21); TW (4); KR (10)