A Study to Assess and Compare Safety and Tolerability of 3 Months Treatment With Salbutamol Administered Via MDI Containing Propellant HFA-152a or HFA-134a in Participants ≥ 18 Years of Age With Asthma

Last updated: April 4, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

3

Condition

Asthma

Treatment

Salbutamol HFA-134a

Salbutamol HFA-152a

Clinical Study ID

NCT06261957
220735
2023-509001-76-00
  • Ages > 18
  • All Genders

Study Summary

The goal of this study is to assess and compare the safety and tolerability of salbutamol administered via metered dose inhaler (MDI) containing propellant 1,1-difluoroethane (HFA-152a) or 1,1,1,2-tetrafluoroethane (HFA-134a) in participants aged >=18 years with asthma

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant of ≥18 years of age at the time of signing the informed consent orwritten 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 (applicableto daily Inhaled corticosteroid (ICS), ICS/Long-acting bronchodilator (LABA),and ICS/LABA/Long-acting muscarinic antagonist [LAMA]), for at least 12 weeksprior to the screening visit, with treatment that is anticipated to remainstable for the duration of the study:

  • Short-Acting Beta-2-Adrenoreceptor Agonists (SABA) used as needed forasthma symptoms

  • Daily maintenance low to medium dose Inhaled corticosteroid (ICS) (low tomedium dose ICS defined as 100-500 μg/day fluticasone propionate orequivalent as defined in the 2023 GINA guidelines [GINA, 2023], plusShort-Acting Beta-2-Adrenoreceptor Agonists (SABA), which is anticipatedto 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 fluticasonepropionate or equivalent as defined in the GINA guidelines [GINA, 2023]plus SABA, which is anticipated to remain stable for the duration of thestudy.

  • Daily maintenance ICS/LABA/LAMA (low to medium dose ICS defined as 100-500 µg/day fluticasone propionate or equivalent as defined in the GINAguidelines [GINA, 2023] plus SABA, which is anticipated to remain stablefor the duration of the study.

  • Participants who utilize combination budesonide/formoterol as relievertherapy, whether or not this is in addition to a SABA - are not eligiblefor 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 onlyeligible if they agree to discontinue their ICS/SABA inhaler for theduration of the study (screening through follow-up).

  1. Severity of disease assessed by the investigator by baseline pre-bronchodilatorForced expiratory volume in 1 second (FEV1)

  2. 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 6months. 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 ofasthma, requiring systemic corticosteroids.

  1. 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 upto 4 inhalations of albuterol/salbutamol aerosol.

  2. 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 yearswill meet this inclusion criterion. Pre- and post-bronchodilator measurementswill still be collected at screening to characterize the degree ofreversibility.

  • Who do not have a documented history of reversibility within the past 2 yearswill 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:

  1. Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA:
  • Do not need to demonstrate reversibility in accordance with the abovedefinition during the screening period. A reversibility maneuver will beperformed 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 hoursfor 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

Exclusion Criteria:

  1. A history of life-threatening asthma or asthma that is unstable in the opinion ofthe 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 respiratoryabnormalities other than asthma.

  3. Respiratory Infection: Culture-documented or suspected bacterial or viral infectionof the upper or lower respiratory tract, sinus or middle ear that is not resolvedwithin 4 weeks of screening that led to a change in asthma management, OR in theopinion 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 toscreening.

  5. Current or chronic history of liver disease or known hepatic or biliaryabnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)Biologic/immunosuppressive therapies used for the treatment of respiratory diseasesduring the 6 months, or 5 half-lives-whichever is longer-prior to start of thestudy.

Study Design

Total Participants: 412
Treatment Group(s): 2
Primary Treatment: Salbutamol HFA-134a
Phase: 3
Study Start date:
May 31, 2024
Estimated Completion Date:
September 24, 2025

Connect with a study center

  • GSK Investigational Site

    Caba, Buenos Aires C1425BEN
    Argentina

    Site Not Available

  • GSK Investigational Site

    Buenos Aires, C1425AZE
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Ciudad de Buenos Aires, C1425AZE
    Argentina

    Site Not Available

  • GSK Investigational Site

    La Plata, 1900
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Mendoza, M5500CCG
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Botany, New South Wales 2019
    Australia

    Active - Recruiting

  • GSK Investigational Site

    Coffs Harbour, New South Wales 2450
    Australia

    Active - Recruiting

  • GSK Investigational Site

    Kanwal, New South Wales 2259
    Australia

    Active - Recruiting

  • GSK Investigational Site

    Murdoch, Western Australia 6163
    Australia

    Active - Recruiting

  • GSK Investigational Site

    Spearwood, Western Australia 6163
    Australia

    Site Not Available

  • GSK Investigational Site

    Ajax, Ontario L1S 2J5
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Brampton, Ontario L6T 0G1
    Canada

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    Ottawa, Ontario K1H 1E4
    Canada

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    Toronto, Ontario M9V 4B4
    Canada

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    Windsor, Ontario N8X 2G1
    Canada

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    Quebec, G1W 4R4
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    Amiens Cedex 1, 80054
    France

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    Argenteuil, 95100
    France

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    Argenteuil cedex, 95100
    France

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    Brest cedex, 29609
    France

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    Cannes, 06614
    France

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    Cannes Cedex, 06614
    France

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    CrEteil cedex, 94010
    France

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    Créteil Cedex, 94010
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    Libourne Cedex, 33505
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    Lille, 59000
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    Poitiers, 86021
    France

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    Poitiers cedex, 86021
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    Pontoise, 95303
    France

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    Strasbourg, 67091
    France

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    Strasbourg Cedex, 67091
    France

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    Alexandroupolis, 68100
    Greece

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    Athens, 15669
    Greece

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    Heraklion, Crete, 71500
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    Larissa, 41110
    Greece

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    Thessaloniki, 57010
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    Italy

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    Cagliari, 09042
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    Firenze, 50134
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    Torino, 10128
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    Rhyl, LL18 4HZ
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    Stonecrest, Georgia 30038
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    Louisville, Kentucky 40217
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    Owensboro, Kentucky 42301
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  • GSK Investigational Site

    Mankato, Minnesota 56001
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    Minneapolis, Minnesota 55402
    United States

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  • GSK Investigational Site

    Minnesota, Minnesota 56001
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  • GSK Investigational Site

    Olive Branch, Mississippi 38654
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  • GSK Investigational Site

    Columbia, Missouri 65203
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    Henderson, Nevada 89052
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    Jersey City, New Jersey 07306
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    Riverdale, New Jersey 07457
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    Brooklyn, New York 11220
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    Asheville, North Carolina 28803
    United States

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    Winston-Salem, North Carolina 27104
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    Cincinnati, Ohio 45231
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    Dublin, Ohio 43016
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    Medford, Oregon 97504
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    DuBois, Pennsylvania 15801
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    Philadelphia, Pennsylvania 19107
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    Pittsburgh, Pennsylvania 15241
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    Pottstown, Pennsylvania 19464
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    Greenville, South Carolina 29615
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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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  • GSK Investigational Site

    Union, South Carolina 29379
    United States

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    Burleson, Texas 76028
    United States

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  • GSK Investigational Site

    Tomball, Texas 77375
    United States

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  • GSK Investigational Site

    Waco, Texas 76712
    United States

    Site Not Available

  • GSK Investigational Site

    Bellingham, Washington 98225
    United States

    Active - Recruiting

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