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

NCT06261957 | Completed Phase 3 FDA Drug

• 2 other identifiers: 2207352023-509001-76-00
• Study Type: interventional
• Target: 477
• Locations: 13 countries
• Sites: 101

Brief 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

Conditions

Asthma

Keywords

Asthma; Salbutamol; MDI; HFA-152a; HFA-134a

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse Events (AEs)

  Up to 3 months

Secondary Outcomes (37)

• Number of participants with Serious Adverse Events (SAEs)

  Up to 3 months

• Absolute Values of Minimum serum potassium (milliequivalents per litre [mEq/L])

  Up to 3 months

• Absolute values of serum potassium (milligrams per decilitre)

  Up to 3 months

• Change from baseline in serum potassium (milligrams per decilitre)

  Baseline (Day 1) and up to 3 months

• Absolute value of haematology parameter: Platelet count (cells per microliter)

  Up to 3 months

Study Arms (2)

Salbutamol Test Arm

EXPERIMENTAL

Drug: Salbutamol HFA-152a

Salbutamol Reference Arm

ACTIVE COMPARATOR

Drug: Salbutamol HFA-134a

Interventions

Salbutamol HFA-134a DRUG

100 microgram (μg) (ex-valve) at 30-second intervals per actuation

Salbutamol Reference Arm

Salbutamol HFA-152a DRUG

100 μg (ex-valve) at 30-second intervals per actuation

Salbutamol Test Arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.
• 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.
• 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.
• Asthma Exacerbation: Any severe asthma exacerbation within 6 months prior to screening.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (101)

GSK Investigational Site

North Hollywood, California, 91606-3287, United States

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GSK Investigational Site

San Mateo, California, 94403, United States

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GSK Investigational Site

Aventura, Florida, 33180, United States

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GSK Investigational Site

Clearwater, Florida, 33756, United States

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GSK Investigational Site

DeLand, Florida, 32720, United States

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GSK Investigational Site

Miami, Florida, 33144, United States

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GSK Investigational Site

Miami, Florida, 33155, United States

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GSK Investigational Site

Miami, Florida, 33173, United States

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Naples, Florida, 34102, United States

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GSK Investigational Site

Plantation, Florida, 33317, United States

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GSK Investigational Site

Winter Park, Florida, 32789, United States

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GSK Investigational Site

Rincon, Georgia, 31326, United States

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GSK Investigational Site

Stonecrest, Georgia, 30038, United States

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GSK Investigational Site

Louisville, Kentucky, 40217, United States

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GSK Investigational Site

Owensboro, Kentucky, 42301, United States

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GSK Investigational Site

Fall River, Massachusetts, 02723, United States

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GSK Investigational Site

Minneapolis, Minnesota, 55402, United States

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GSK Investigational Site

Minneota, Minnesota, 56001, United States

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GSK Investigational Site

Olive Branch, Mississippi, 38654, United States

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Columbia, Missouri, 65203, United States

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Henderson, Nevada, 89052, United States

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GSK Investigational Site

Jersey City, New Jersey, 07306, United States

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GSK Investigational Site

Riverdale, New Jersey, 07457, United States

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GSK Investigational Site

Brooklyn, New York, 11220, United States

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GSK Investigational Site

Asheville, North Carolina, 28803, United States

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GSK Investigational Site

Winston-Salem, North Carolina, 27104, United States

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GSK Investigational Site

Cincinnati, Ohio, 45231, United States

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GSK Investigational Site

Dublin, Ohio, 43016, United States

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GSK Investigational Site

Medford, Oregon, 97504, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15241, United States

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GSK Investigational Site

Pottstown, Pennsylvania, 19464, United States

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GSK Investigational Site

Rock Hill, South Carolina, 29732, United States

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GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

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GSK Investigational Site

Union, South Carolina, 29379, United States

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GSK Investigational Site

Sugar Land, Texas, 77479, United States

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GSK Investigational Site

Tomball, Texas, 77375, United States

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GSK Investigational Site

Buenos Aires, C1425AZE, Argentina

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GSK Investigational Site

Buenos Aires, C1425BEN, Argentina

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GSK Investigational Site

Buenos Aires, C1426ABP, Argentina

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GSK Investigational Site

La Plata, 1900, Argentina

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GSK Investigational Site

Mendoza, M5500CCG, Argentina

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GSK Investigational Site

Botany, New South Wales, 2019, Australia

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GSK Investigational Site

Coffs Harbour, New South Wales, 2450, Australia

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GSK Investigational Site

Kanwal, New South Wales, 2259, Australia

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GSK Investigational Site

Spearwood, Western Australia, 6163, Australia

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GSK Investigational Site

Ajax, Ontario, L1S 2J5, Canada

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GSK Investigational Site

Brampton, Ontario, L6T 0G1, Canada

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GSK Investigational Site

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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GSK Investigational Site

Québec, Quebec, G1V 4W2, Canada

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GSK Investigational Site

Québec, Quebec, G1W 4R4, Canada

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GSK Investigational Site

Amiens, 80054, France

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GSK Investigational Site

Argenteuil, 95100, France

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GSK Investigational Site

Créteil, 94010, France

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GSK Investigational Site

Poitiers, 86021, France

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GSK Investigational Site

Pontoise, 95303, France

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GSK Investigational Site

Strasbourg, 67091, France

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GSK Investigational Site

Athens, 15669, Greece

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GSK Investigational Site

Larissa, 41110, Greece

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GSK Investigational Site

Thessaloniki, 57010, Greece

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GSK Investigational Site

Cagliari, 09042, Italy

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GSK Investigational Site

Florence, 50134, Italy

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GSK Investigational Site

Foggia, 71100, Italy

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GSK Investigational Site

Milan, 20162, Italy

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GSK Investigational Site

Naples, 80131, Italy

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GSK Investigational Site

Padua, 35128, Italy

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Roma, Italy

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GSK Investigational Site

Torino, 10128, Italy

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GSK Investigational Site

Tradate VA, 21100, Italy

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GSK Investigational Site

Verona, 37134, Italy

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GSK Investigational Site

Panama City, 7002, Panama

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GSK Investigational Site

Panama City, 7099, Panama

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GSK Investigational Site

Panama City, Panama

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GSK Investigational Site

Iloilo City, 5000, Philippines

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GSK Investigational Site

Bialystok, 15-010, Poland

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GSK Investigational Site

Bielsko-Biala, 43-300, Poland

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GSK Investigational Site

Chorzów, 41-500, Poland

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GSK Investigational Site

Elblag, 82-300, Poland

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GSK Investigational Site

Katowice, 40-600, Poland

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GSK Investigational Site

Ostrowiec Świętokrzyski, 27-400, Poland

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GSK Investigational Site

Płock, 09-407, Poland

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GSK Investigational Site

Tarnów, 33-100, Poland

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GSK Investigational Site

Barcelona, 08017, Spain

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GSK Investigational Site

Barcelona, 08540, Spain

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GSK Investigational Site

Benalmádena, 29631, Spain

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GSK Investigational Site

Madrid, 28031, Spain

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GSK Investigational Site

Madrid, 28040, Spain

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GSK Investigational Site

Madrid, 28041, Spain

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GSK Investigational Site

Marbella, 29603, Spain

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GSK Investigational Site

Pozuelo de AlarcOn Madr, 28223, Spain

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GSK Investigational Site

Pathum Thani, 12120, Thailand

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GSK Investigational Site

Bebington, CH63 9JP, United Kingdom

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GSK Investigational Site

Cambridgeshire, CB7 5JD, United Kingdom

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GSK Investigational Site

Corby, NN17 2UR, United Kingdom

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GSK Investigational Site

Greater Manchester, OL6 6HD, United Kingdom

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GSK Investigational Site

Guisborough, TS14 7DJ, United Kingdom

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GSK Investigational Site

Hounslow, TW3 3EL, United Kingdom

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GSK Investigational Site

Rhyl, LL18 4HZ, United Kingdom

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GSK Investigational Site

Uttoxeter, ST14 5JX, United Kingdom

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MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 15, 2024
• Study Start: May 31, 2024
• Primary Completion: September 2, 2025
• Study Completion: September 2, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

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

GB (8); US (37); PL (8); AR (5); PA (3); FR (6); IT (10); ES (8); TH (1); CA (7); AU (4); GR (3); PH (1)