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New triple inhaler could help teens with Hard-to-Control asthma

NCT ID NCT05757102

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This study tests whether a triple-combination inhaler (containing three drugs) works better than a standard dual-combination inhaler for teenagers aged 12-17 whose asthma is not well controlled. About 292 participants will use either the triple or dual inhaler daily for 24 weeks. The main goal is to see if the triple inhaler improves lung function more than the dual one.

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, and vilanterol (a triple-combination inhaler)
What this could lead to
If it works, this could offer a more effective daily inhaler option for teenagers whose asthma is not well controlled with current two-drug inhalers.
What could go wrong
This is a relatively small, short-term study (24 weeks) in a specific age group. The triple inhaler may not prove significantly better than the standard dual inhaler, and long-term safety in teens is not yet established.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 292 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Jan 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

12 to 17 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: * Participant must be 12 to 17 years of age (inclusive), at the time of signing the informed consent/assent. * Participants who have a diagnosis of asthma as defined by the National Institutes of Health \[NIH, 2020\] at least 1 year prior to Visit 0. * Participants who have required daily Inhaled corticosteroids (ICS)/ Long-Acting Beta2-Agonist (LABA) treatment for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total ICS dose of \>250 to \<=500 microgram (mcg)/day fluticasone propionate, or equivalent). * In the 1 year prior to Visit 1: A documented healthcare contact for acute asthma symptoms; OR A documented temporary change in asthma therapy for acute asthma symptoms, according to a prespecified asthma action plan (or equivalent). * Participants with inadequately controlled asthma (ACQ-6 score ≥1.5) at Visit 1, despite ICS/LABA maintenance therapy. * A best pre-bronchodilator FEV1 \>40% to \<=90% of the predicted normal value and a ≥12% increase in FEV1 with albuterol/salbutamol at Visit 1. Predicted values will be based on the European Respiratory Society (ERS) Global Lung Function Initiative. Exclusion Criteria: * Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1. * Any asthma exacerbation requiring a change in maintenance asthma therapy and/or the use of systemic corticosteroids for at least 3 days in the 6 weeks prior to Visit 1. (Participants requiring a temporary change in asthma therapy (e.g., oral corticosteroids or increased dose of ICS) to treat an exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1 provided that, at the Investigator's discretion, the participant's condition is stable after they have resumed their pre-exacerbation maintenance asthma therapy (without modification), returned to their baseline asthma status and they are considered appropriate for enrollment into this study of up to 6 months duration) * History of Life-threatening Asthma * Participants with current evidence of active pulmonary diseases or abnormalities other than asthma (e.g., pneumonia, active tuberculosis, significant bronchiectasis, etc.). * Current smokers and users of other inhaled products for recreation with or without nicotine (defined as participants who use cigarettes, e-cigarettes, other/vaping-related devices, cigars or pipe tobacco\]) within 12 months prior to Visit 1.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    57 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Birmingham, Alabama, 35244, United States

  • GSK Investigational Site

    RECRUITING

    Mobile, Alabama, 36608, United States

  • GSK Investigational Site

    RECRUITING

    Paradise Valley, Arizona, 85253, United States

  • GSK Investigational Site

    RECRUITING

    Bakersfield, California, 93301, United States

  • GSK Investigational Site

    RECRUITING

    Huntington Beach, California, 92647, United States

  • GSK Investigational Site

    RECRUITING

    Mission Viejo, California, 92691, United States

  • GSK Investigational Site

    COMPLETED

    Rolling Hills Estates, California, 90274, United States

  • GSK Investigational Site

    RECRUITING

    Colorado Springs, Colorado, 80909, United States

  • GSK Investigational Site

    COMPLETED

    Aventura, Florida, 33180, United States

  • GSK Investigational Site

    RECRUITING

    Miami, Florida, 33165, United States

  • GSK Investigational Site

    COMPLETED

    Miami, Florida, 33173, United States

  • GSK Investigational Site

    RECRUITING

    Miami, Florida, 33174, United States

  • GSK Investigational Site

    COMPLETED

    Savannah, Georgia, 31406, United States

  • GSK Investigational Site

    RECRUITING

    Normal, Illinois, 61761, United States

  • GSK Investigational Site

    RECRUITING

    Owensboro, Kentucky, 42301, United States

  • GSK Investigational Site

    COMPLETED

    Columbia, Missouri, 65203, United States

  • GSK Investigational Site

    RECRUITING

    Missoula, Montana, 59808, United States

  • GSK Investigational Site

    RECRUITING

    The Bronx, New York, 10461-1119, United States

  • GSK Investigational Site

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • GSK Investigational Site

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • GSK Investigational Site

    COMPLETED

    Dayton, Ohio, 45404, United States

  • GSK Investigational Site

    RECRUITING

    Oklahoma City, Oklahoma, 73120-9350, United States

  • GSK Investigational Site

    RECRUITING

    Charleston, South Carolina, 29420, United States

  • GSK Investigational Site

    RECRUITING

    Dallas, Texas, 75225-6301, United States

  • GSK Investigational Site

    RECRUITING

    Kerrville, Texas, 78028, United States

  • GSK Investigational Site

    COMPLETED

    Plano, Texas, 75034, United States

  • GSK Investigational Site

    COMPLETED

    Waco, Texas, 76712, United States

  • GSK Investigational Site

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • GSK Investigational Site

    RECRUITING

    Buenos Aires, 1122, Argentina

  • GSK Investigational Site

    RECRUITING

    Buenos Aires, 1888, Argentina

  • GSK Investigational Site

    RECRUITING

    Buenos Aires, C1023AAB, Argentina

  • GSK Investigational Site

    RECRUITING

    Buenos Aires, C1202, Argentina

  • GSK Investigational Site

    RECRUITING

    Buenos Aires, C1425BEN, Argentina

  • GSK Investigational Site

    RECRUITING

    Córdoba, X5000DCE, Argentina

  • GSK Investigational Site

    RECRUITING

    Córdoba, X5014AKM, Argentina

  • GSK Investigational Site

    RECRUITING

    Lanus, B1824KAJ, Argentina

  • GSK Investigational Site

    RECRUITING

    Lobos, 7240, Argentina

  • GSK Investigational Site

    RECRUITING

    Lujan de Cuyo, 5509, Argentina

  • GSK Investigational Site

    RECRUITING

    Mar del Plata, 7600, Argentina

  • GSK Investigational Site

    RECRUITING

    Rosario, 2000, Argentina

  • GSK Investigational Site

    RECRUITING

    Rosario Provincia de Santa FE, 2000, Argentina

  • GSK Investigational Site

    RECRUITING

    San Miguel de Tucumán, T4000IHE, Argentina

  • GSK Investigational Site

    RECRUITING

    Santa Fe, 3000, Argentina

  • GSK Investigational Site

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • GSK Investigational Site

    RECRUITING

    North Adelaide, South Australia, 5006, Australia

  • GSK Investigational Site

    RECRUITING

    Joondalup WA, Western Australia, 6027, Australia

  • GSK Investigational Site

    RECRUITING

    Lo Barnechea, 7691236, Chile

  • GSK Investigational Site

    RECRUITING

    Santiago, 7630000, Chile

  • GSK Investigational Site

    RECRUITING

    Santiago, 8320000, Chile

  • GSK Investigational Site

    RECRUITING

    Ashkelon, 7830604, Israel

  • GSK Investigational Site

    RECRUITING

    Haifa, 3109600, Israel

  • GSK Investigational Site

    RECRUITING

    Haifa, 3436212, Israel

  • GSK Investigational Site

    COMPLETED

    Petah Tikva, 49202, Israel

  • GSK Investigational Site

    RECRUITING

    Guadalajara, 44100, Mexico

  • GSK Investigational Site

    RECRUITING

    Monterrey, 64460, Mexico

  • GSK Investigational Site

    RECRUITING

    San Juan del Río, 76800, Mexico

  • GSK Investigational Site

    RECRUITING

    Ebdentown, Upper Hutt, 5018, New Zealand

  • GSK Investigational Site

    RECRUITING

    Cheongju Chungcheongbuk-do, 28644, South Korea

  • GSK Investigational Site

    RECRUITING

    Gwangju, 501-757, South Korea

  • GSK Investigational Site

    COMPLETED

    Seoul, 03722, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 05505, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 1757, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 2447, South Korea

  • GSK Investigational Site

    RECRUITING

    Adana, 1173, Turkey (Türkiye)

  • GSK Investigational Site

    RECRUITING

    Antalya, 07070, Turkey (Türkiye)

  • GSK Investigational Site

    RECRUITING

    Istanbul, 34010, Turkey (Türkiye)

  • GSK Investigational Site

    RECRUITING

    Istanbul, 34899, Turkey (Türkiye)

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