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New triple inhaler could offer better asthma control for millions

NCT ID NCT06372496

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a triple-combination inhaler (FF/UMEC/VI) works better than standard dual therapy (ICS/LABA) for adults whose asthma is not well controlled. About 1,366 participants will use either the triple inhaler or their usual treatment for 24 weeks. The main goal is to see if lung function improves more with the triple inhaler.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (a triple-combination inhaler)
What this could lead to
If successful, this could show that the triple-combination inhaler controls asthma better than standard dual therapy, potentially reducing symptoms and improving lung function.
What could go wrong
This is a Phase 4 study comparing existing drugs, so no breakthrough is expected. Results may show only modest benefits, and individual responses can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1,366 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

  • GSK Investigational Site

    Centreville, Alabama, 35042, United States

  • GSK Investigational Site

    Little Rock, Arkansas, 72205, United States

  • GSK Investigational Site

    Newport Beach, California, 92663, United States

  • GSK Investigational Site

    Newark, Delaware, 08901, United States

  • GSK Investigational Site

    Clearwater, Florida, 33765-2150, United States

  • GSK Investigational Site

    Florida City, Florida, 32819, United States

  • GSK Investigational Site

    Miami, Florida, 15801, United States

  • GSK Investigational Site

    Miami, Florida, 33126, United States

  • GSK Investigational Site

    Miami, Florida, 33135, United States

  • GSK Investigational Site

    Miami, Florida, 33173, United States

  • GSK Investigational Site

    North Miami Beach, Florida, 33169, United States

  • GSK Investigational Site

    Palm Springs, Florida, 33406, United States

  • GSK Investigational Site

    Port Charlotte, Florida, 33952, United States

  • GSK Investigational Site

    Tallahassee, Florida, 32308, United States

  • GSK Investigational Site

    Normal, Illinois, 61761, United States

  • GSK Investigational Site

    New Orleans, Louisiana, 20852, United States

  • GSK Investigational Site

    Bangor, Maine, 04401, United States

  • GSK Investigational Site

    Detroit, Michigan, 48202, United States

  • GSK Investigational Site

    Warren, Michigan, 48088, United States

  • GSK Investigational Site

    Missoula, Montana, 59804, United States

  • GSK Investigational Site

    Papillion, Nebraska, 68046, United States

  • GSK Investigational Site

    Brick, New Jersey, 08724, United States

  • GSK Investigational Site

    Linwood, New Jersey, 08221, United States

  • GSK Investigational Site

    New Windsor, New York, 12553, United States

  • GSK Investigational Site

    Asheville, North Carolina, 28801, United States

  • GSK Investigational Site

    Charlotte, North Carolina, 28273, United States

  • GSK Investigational Site

    Greenville, North Carolina, 27834, United States

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27104, United States

  • GSK Investigational Site

    Cincinnati, Ohio, 45231, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19140, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15241, United States

  • GSK Investigational Site

    Rock Hill, South Carolina, 29732, United States

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303, United States

  • GSK Investigational Site

    Beaumont, Texas, 77701, United States

  • GSK Investigational Site

    Dallas, Texas, 75225, United States

  • GSK Investigational Site

    Bellingham, Washington, 98225, United States

  • GSK Investigational Site

    Buenos Aires, C1128AAF, Argentina

  • GSK Investigational Site

    Buenos Aires, C1192AAW, Argentina

  • GSK Investigational Site

    Buenos Aires, C1425BEN, Argentina

  • GSK Investigational Site

    Buenos Aires, FVH1425, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, 1012, Argentina

  • GSK Investigational Site

    Concepción del Uruguay, 3260, Argentina

  • GSK Investigational Site

    Córdoba, X5003DCE, Argentina

  • GSK Investigational Site

    Formosa, 3600, Argentina

  • GSK Investigational Site

    Lujan de Cuyo, 5509, Argentina

  • GSK Investigational Site

    Luján, 6700, Argentina

  • GSK Investigational Site

    Mar del Plata, 7600, Argentina

  • GSK Investigational Site

    Mendoza, 5500, Argentina

  • GSK Investigational Site

    Mendoza, 5577, Argentina

  • GSK Investigational Site

    Mendoza, M5500, Argentina

  • GSK Investigational Site

    Quilmes, 1878, Argentina

  • GSK Investigational Site

    Rosario, 2000, Argentina

  • GSK Investigational Site

    Rosario, S2000 DEJ, Argentina

  • GSK Investigational Site

    Rosario, S2000DBS, Argentina

  • GSK Investigational Site

    San Juan Bautista, 1888, Argentina

  • GSK Investigational Site

    San Miguel de Tucumán, T4000AXL, Argentina

  • GSK Investigational Site

    Santa Fe, 3000, Argentina

  • GSK Investigational Site

    Bruce, Australian Capital Territory, 2617, Australia

  • GSK Investigational Site

    Blacktown, New South Wales, 2148, Australia

  • GSK Investigational Site

    Coffs Harbour, New South Wales, 2450, Australia

  • GSK Investigational Site

    Kanwal, New South Wales, 2259, Australia

  • GSK Investigational Site

    Sydney, New South Wales, 2035, Australia

  • GSK Investigational Site

    Brisbane, Queensland, 4006, Australia

  • GSK Investigational Site

    Osborne Park, Western Australia, 6017, Australia

  • GSK Investigational Site

    Spearwood, Western Australia, 6163, Australia

  • GSK Investigational Site

    Windsor, Ontario, N8X 1T3, Canada

  • GSK Investigational Site

    Trois-Rivières, Quebec, G9A 4P3, Canada

  • GSK Investigational Site

    Chancheng District, Foshan City, 528031, China

  • GSK Investigational Site

    Liwan District, Guangzhou, 510160, China

  • GSK Investigational Site

    North Street, Jiangmen City, 52900, China

  • GSK Investigational Site

    Nanshan District, 518067, China

  • GSK Investigational Site

    Zhuhai, 519099, China

  • GSK Investigational Site

    Fukuoka, 802-0083, Japan

  • GSK Investigational Site

    Fukuoka, 807-8555, Japan

  • GSK Investigational Site

    Fukuoka, 816-0813, Japan

  • GSK Investigational Site

    Fukuoka, 820-8505, Japan

  • GSK Investigational Site

    Fukuoka, 832-0059, Japan

  • GSK Investigational Site

    Gifu, 509-6134, Japan

  • GSK Investigational Site

    Hiroshima, 730-0013, Japan

  • GSK Investigational Site

    Hiroshima, 730-0853, Japan

  • GSK Investigational Site

    Hiroshima, 733-0002, Japan

  • GSK Investigational Site

    Hyōgo, 651-0053, Japan

  • GSK Investigational Site

    Kagawa, 761-8073, Japan

  • GSK Investigational Site

    Kagoshima, 890-0053, Japan

  • GSK Investigational Site

    Kanagawa, 252-0143, Japan

  • GSK Investigational Site

    Kumamoto, 860-8556, Japan

  • GSK Investigational Site

    Kumamoto, 862-0965, Japan

  • GSK Investigational Site

    Matsuyama, 790-0925, Japan

  • GSK Investigational Site

    Miyagi, 980-0871, Japan

  • GSK Investigational Site

    Miyazaki, 880-2112, Japan

  • GSK Investigational Site

    Miyazaki, 889-4304, Japan

  • GSK Investigational Site

    Nagaoka-Shi, 940-0087, Japan

  • GSK Investigational Site

    Niigata, 950-0088, Japan

  • GSK Investigational Site

    Okawa-shi, 831-0016, Japan

  • GSK Investigational Site

    Ōita, Japan

  • GSK Investigational Site

    Shinjuku-kuTokyo, 160-0021, Japan

  • GSK Investigational Site

    Tokyo, 105-0001, Japan

  • GSK Investigational Site

    Tokyo, 142-8666, Japan

  • GSK Investigational Site

    Tokyo, 145-0063, Japan

  • GSK Investigational Site

    Tokyo, 157-0066, Japan

  • GSK Investigational Site

    Tokyo, 160-0017, Japan

  • GSK Investigational Site

    Tokyo, 173-8606, Japan

  • GSK Investigational Site

    Yokohama, 223-0053, Japan

  • GSK Investigational Site

    Busan, 602 702, South Korea

  • GSK Investigational Site

    Daegu, 41404, South Korea

  • GSK Investigational Site

    Seongnam-si Gyeonggi-do, 13620, South Korea

  • GSK Investigational Site

    Seoul, 02841, South Korea

  • GSK Investigational Site

    Seoul, 03080, South Korea

  • GSK Investigational Site

    Seoul, 07061, South Korea

  • GSK Investigational Site

    Seoul, 133-792, South Korea

  • GSK Investigational Site

    Seoul, 158-710, South Korea

  • GSK Investigational Site

    Seoul, 5030, South Korea

  • GSK Investigational Site

    Suwon Kyunggi-do, 16499, South Korea

  • GSK Investigational Site

    Kaohsiung City, 807, Taiwan

  • GSK Investigational Site

    Taichung, 40447, Taiwan

  • GSK Investigational Site

    Taichung, 407219, Taiwan

  • GSK Investigational Site

    Taipei, 10002, Taiwan

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Other studies related to the condition(s) this trial covers.