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Asthma inhaler upgrade? new propellant passes safety check

NCT ID NCT06261957

Symptom relief 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study checked if a new propellant (HFA-152a) in salbutamol rescue inhalers is as safe as the current one (HFA-134a) for adults with asthma. 477 participants used the inhalers over time, and researchers tracked side effects. The goal was to ensure the new propellant is safe for regular use.

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

477 people

The number who actually took part.

Started

May 2024

Finished

Sep 2025

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 years and older

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: 1. Participant of ≥18 years of age at the time of signing the informed consent or written informed consent is obtained from each study participant's legal guardian. 2. Asthma for ≥ 6 months, defined as: * Documented history of asthma, as defined by Global Initiative for Asthma (GINA) (GINA, 2023\] * Receiving one of the following asthma treatments, at a stable dose (applicable to daily Inhaled corticosteroid (ICS), ICS/Long-acting bronchodilator (LABA), and ICS/LABA/Long-acting muscarinic antagonist \[LAMA\]), for at least 12 weeks prior to the screening visit, with treatment that is anticipated to remain stable for the duration of the study: * Short-Acting Beta-2-Adrenoreceptor Agonists (SABA) used as needed for asthma symptoms * Daily maintenance low to medium dose Inhaled corticosteroid (ICS) (low to medium dose ICS defined as 100-500 μg/day fluticasone propionate or equivalent as defined in the 2023 GINA guidelines \[GINA, 2023\], plus Short-Acting Beta-2-Adrenoreceptor Agonists (SABA), which is anticipated to remain stable for the duration of the study. * Daily maintenance low to medium dose ICS/ Long-acting bronchodilator (LABA) (low to medium dose ICS defined as 100-500 μg/day fluticasone propionate or equivalent as defined in the GINA guidelines \[GINA, 2023\] plus SABA, which is anticipated to remain stable for the duration of the study. * Daily maintenance ICS/LABA/LAMA (low to medium dose ICS defined as 100-500 µg/day fluticasone propionate or equivalent as defined in the GINA guidelines \[GINA, 2023\] plus SABA, which is anticipated to remain stable for the duration of the study. * Participants who utilize combination budesonide/formoterol as reliever therapy, whether or not this is in addition to a SABA - are not eligible for screening. * Participants who utilize ICS/SABA combination therapy as reliever therapy, in addition to low to medium dose ICS or ICS/LABA as maintenance, are only eligible if they agree to discontinue their ICS/SABA inhaler for the duration of the study (screening through follow-up). 3. Severity of disease assessed by the investigator by baseline pre-bronchodilator Forced expiratory volume in 1 second (FEV1) 4. Asthma Control Status * Asthma Control Questionnaire (ACQ) 6 score \<1.5 at screening * Asthma that has remained stable with no severe exacerbations in the last 6 months. Severe exacerbation defined as: * Deterioration of asthma-requiring the use of systemic corticosteroids (tablets, suspension or injection), for at least 3 days, OR * An inpatient hospitalization or Emergency Department (ED) visit because of asthma, requiring systemic corticosteroids. 5. Evidence of reversibility of disease: Airway reversibility is defined as ≥12 percent (%) and ≥200 milliliter (mL) increase in FEV1 within 20 to 60 minutes following up to 4 inhalations of albuterol/salbutamol aerosol. 6. Participants on as-needed SABA only, or daily maintenance ICS (plus as needed SABA): * With a documented history of reversibility (as defined above) within 2 years will meet this inclusion criterion. Pre- and post-bronchodilator measurements will still be collected at screening to characterize the degree of reversibility. * Who do not have a documented history of reversibility within the past 2 years will need to demonstrate reversibility during the screening period. * SABA should be withheld for ≥6 hours * Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA: 7. Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA: * Do not need to demonstrate reversibility in accordance with the above definition during the screening period. A reversibility maneuver will be performed to characterize the degree of post-bronchodilator change. * SABA should be withheld for ≥6 hours * LABA- and LAMA-containing medications should be withheld for \>=24 hours for the characterization of post-bronchodilator change. Participants should be able to withhold SABA for ≥6 hours and LABA-/ LAMA containing medications for ≥24 hours for the purposes of performing screening spirometry. Exclusion Criteria: 1. A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator. 2. Other significant pulmonary diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, tuberculosis or other respiratory abnormalities other than asthma. 3. Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening that led to a change in asthma management, OR in the opinion of the Investigator, is expected to affect the participant's asthma status, OR the participant's ability to participate in the study. 4. Asthma Exacerbation: Any severe asthma exacerbation within 6 months prior to screening. 5. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) Biologic/immunosuppressive therapies used for the treatment of respiratory diseases during the 6 months, or 5 half-lives-whichever is longer-prior to start of the study.

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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

    North Hollywood, California, 91606-3287, United States

  • GSK Investigational Site

    San Mateo, California, 94403, United States

  • GSK Investigational Site

    Aventura, Florida, 33180, United States

  • GSK Investigational Site

    Clearwater, Florida, 33756, United States

  • GSK Investigational Site

    DeLand, Florida, 32720, United States

  • GSK Investigational Site

    Miami, Florida, 33144, United States

  • GSK Investigational Site

    Miami, Florida, 33155, United States

  • GSK Investigational Site

    Miami, Florida, 33173, United States

  • GSK Investigational Site

    Naples, Florida, 34102, United States

  • GSK Investigational Site

    Plantation, Florida, 33317, United States

  • GSK Investigational Site

    Winter Park, Florida, 32789, United States

  • GSK Investigational Site

    Rincon, Georgia, 31326, United States

  • GSK Investigational Site

    Stonecrest, Georgia, 30038, United States

  • GSK Investigational Site

    Louisville, Kentucky, 40217, United States

  • GSK Investigational Site

    Owensboro, Kentucky, 42301, United States

  • GSK Investigational Site

    Fall River, Massachusetts, 02723, United States

  • GSK Investigational Site

    Minneapolis, Minnesota, 55402, United States

  • GSK Investigational Site

    Minneota, Minnesota, 56001, United States

  • GSK Investigational Site

    Olive Branch, Mississippi, 38654, United States

  • GSK Investigational Site

    Columbia, Missouri, 65203, United States

  • GSK Investigational Site

    Henderson, Nevada, 89052, United States

  • GSK Investigational Site

    Jersey City, New Jersey, 07306, United States

  • GSK Investigational Site

    Riverdale, New Jersey, 07457, United States

  • GSK Investigational Site

    Brooklyn, New York, 11220, United States

  • GSK Investigational Site

    Asheville, North Carolina, 28803, United States

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27104, United States

  • GSK Investigational Site

    Cincinnati, Ohio, 45231, United States

  • GSK Investigational Site

    Dublin, Ohio, 43016, United States

  • GSK Investigational Site

    Medford, Oregon, 97504, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15241, United States

  • GSK Investigational Site

    Pottstown, Pennsylvania, 19464, United States

  • GSK Investigational Site

    Rock Hill, South Carolina, 29732, United States

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303, United States

  • GSK Investigational Site

    Union, South Carolina, 29379, United States

  • GSK Investigational Site

    Sugar Land, Texas, 77479, United States

  • GSK Investigational Site

    Tomball, Texas, 77375, United States

  • GSK Investigational Site

    Buenos Aires, C1425AZE, Argentina

  • GSK Investigational Site

    Buenos Aires, C1425BEN, Argentina

  • GSK Investigational Site

    Buenos Aires, C1426ABP, Argentina

  • GSK Investigational Site

    La Plata, 1900, Argentina

  • GSK Investigational Site

    Mendoza, M5500CCG, Argentina

  • GSK Investigational Site

    Botany, New South Wales, 2019, Australia

  • GSK Investigational Site

    Coffs Harbour, New South Wales, 2450, Australia

  • GSK Investigational Site

    Kanwal, New South Wales, 2259, Australia

  • GSK Investigational Site

    Spearwood, Western Australia, 6163, Australia

  • GSK Investigational Site

    Ajax, Ontario, L1S 2J5, Canada

  • GSK Investigational Site

    Brampton, Ontario, L6T 0G1, Canada

  • GSK Investigational Site

    Ottawa, Ontario, K1H 1E4, Canada

  • GSK Investigational Site

    Toronto, Ontario, M9V 4B4, Canada

  • GSK Investigational Site

    Windsor, Ontario, N8X 2G1, Canada

  • GSK Investigational Site

    Québec, Quebec, G1V 4W2, Canada

  • GSK Investigational Site

    Québec, Quebec, G1W 4R4, Canada

  • GSK Investigational Site

    Amiens, 80054, France

  • GSK Investigational Site

    Argenteuil, 95100, France

  • GSK Investigational Site

    Créteil, 94010, France

  • GSK Investigational Site

    Poitiers, 86021, France

  • GSK Investigational Site

    Pontoise, 95303, France

  • GSK Investigational Site

    Strasbourg, 67091, France

  • GSK Investigational Site

    Athens, 15669, Greece

  • GSK Investigational Site

    Larissa, 41110, Greece

  • GSK Investigational Site

    Thessaloniki, 57010, Greece

  • GSK Investigational Site

    Cagliari, 09042, Italy

  • GSK Investigational Site

    Florence, 50134, Italy

  • GSK Investigational Site

    Foggia, 71100, Italy

  • GSK Investigational Site

    Milan, 20162, Italy

  • GSK Investigational Site

    Naples, 80131, Italy

  • GSK Investigational Site

    Padova, 35128, Italy

  • GSK Investigational Site

    Roma, Italy

  • GSK Investigational Site

    Torino, 10128, Italy

  • GSK Investigational Site

    Tradate VA, 21100, Italy

  • GSK Investigational Site

    Verona, 37134, Italy

  • GSK Investigational Site

    Panama City, 7002, Panama

  • GSK Investigational Site

    Panama City, 7099, Panama

  • GSK Investigational Site

    Panama City, Panama

  • GSK Investigational Site

    Iloilo City, 5000, Philippines

  • GSK Investigational Site

    Bialystok, 15-010, Poland

  • GSK Investigational Site

    Bielsko-Biala, 43-300, Poland

  • GSK Investigational Site

    Chorzów, 41-500, Poland

  • GSK Investigational Site

    Elblag, 82-300, Poland

  • GSK Investigational Site

    Katowice, 40-600, Poland

  • GSK Investigational Site

    Ostrowiec Świętokrzyski, 27-400, Poland

  • GSK Investigational Site

    Płock, 09-407, Poland

  • GSK Investigational Site

    Tarnów, 33-100, Poland

  • GSK Investigational Site

    Barcelona, 08017, Spain

  • GSK Investigational Site

    Barcelona, 08540, Spain

  • GSK Investigational Site

    Benalmádena, 29631, Spain

  • GSK Investigational Site

    Madrid, 28031, Spain

  • GSK Investigational Site

    Madrid, 28040, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Marbella, 29603, Spain

  • GSK Investigational Site

    Pozuelo de AlarcOn Madr, 28223, Spain

  • GSK Investigational Site

    Pathum Thani, 12120, Thailand

  • GSK Investigational Site

    Bebington, CH63 9JP, United Kingdom

  • GSK Investigational Site

    Cambridgeshire, CB7 5JD, United Kingdom

  • GSK Investigational Site

    Corby, NN17 2UR, United Kingdom

  • GSK Investigational Site

    Greater Manchester, OL6 6HD, United Kingdom

  • GSK Investigational Site

    Guisborough, TS14 7DJ, United Kingdom

  • GSK Investigational Site

    Hounslow, TW3 3EL, United Kingdom

  • GSK Investigational Site

    Rhyl, LL18 4HZ, United Kingdom

  • GSK Investigational Site

    Uttoxeter, ST14 5JX, United Kingdom

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