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

A Randomized, Double-blind, Parallel Group, Multi-center Study to Evaluate the Long-term Safety of Salbutamol Rescue Medication When Administered Via Metered Dose Inhalers Containing the Propellant HFA-152a or Reference HFA-134a

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Salbutamol HFA-152a; Drug: Salbutamol HFA-134a

• Study Type: Interventional
• Enrollment (Actual): 477
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425BEN
    • GSK Investigational Site
  • Buenos Aires, Argentina, C1426ABP
    • GSK Investigational Site
  • Buenos Aires, Argentina, C1425AZE
    • GSK Investigational Site
  • La Plata, Argentina, 1900
    • GSK Investigational Site
  • Mendoza, Argentina, M5500CCG
    • GSK Investigational Site
• Australia
  • New South Wales
    • Botany, New South Wales, Australia, 2019
      • GSK Investigational Site
    • Coffs Harbour, New South Wales, Australia, 2450
      • GSK Investigational Site
    • Kanwal, New South Wales, Australia, 2259
      • GSK Investigational Site
  • Western Australia
    • Spearwood, Western Australia, Australia, 6163
      • GSK Investigational Site
• Canada
  • Ontario
    • Ajax, Ontario, Canada, L1S 2J5
      • GSK Investigational Site
    • Brampton, Ontario, Canada, L6T 0G1
      • GSK Investigational Site
    • Ottawa, Ontario, Canada, K1H 1E4
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M9V 4B4
      • GSK Investigational Site
    • Windsor, Ontario, Canada, N8X 2G1
      • GSK Investigational Site
  • Quebec
    • Québec, Quebec, Canada, G1V 4W2
      • GSK Investigational Site
    • Québec, Quebec, Canada, G1W 4R4
      • GSK Investigational Site
• France
  • Amiens, France, 80054
    • GSK Investigational Site
  • Argenteuil, France, 95100
    • GSK Investigational Site
  • Créteil, France, 94010
    • GSK Investigational Site
  • Poitiers, France, 86021
    • GSK Investigational Site
  • Pontoise, France, 95303
    • GSK Investigational Site
  • Strasbourg, France, 67091
    • GSK Investigational Site
• Greece
  • Athens, Greece, 15669
    • GSK Investigational Site
  • Larissa, Greece, 41110
    • GSK Investigational Site
  • Thessaloniki, Greece, 57010
    • GSK Investigational Site
• Italy
  • Cagliari, Italy, 09042
    • GSK Investigational Site
  • Florence, Italy, 50134
    • GSK Investigational Site
  • Foggia, Italy, 71100
    • GSK Investigational Site
  • Milan, Italy, 20162
    • GSK Investigational Site
  • Napoli, Italy, 80131
    • GSK Investigational Site
  • Padua, Italy, 35128
    • GSK Investigational Site
  • Roma, Italy
    • GSK Investigational Site
  • Torino, Italy, 10128
    • GSK Investigational Site
  • Tradate VA, Italy, 21100
    • GSK Investigational Site
  • Verona, Italy, 37134
    • GSK Investigational Site
• Panama
  • Panama City, Panama
    • GSK Investigational Site
  • Panama City, Panama, 7099
    • GSK Investigational Site
  • Panama City, Panama, 7002
    • GSK Investigational Site
• Philippines
  • Iloilo City, Philippines, 5000
    • GSK Investigational Site
• Poland
  • Bialystok, Poland, 15-010
    • GSK Investigational Site
  • Bielsko-Biala, Poland, 43-300
    • GSK Investigational Site
  • Chorzów, Poland, 41-500
    • GSK Investigational Site
  • Elblag, Poland, 82-300
    • GSK Investigational Site
  • Katowice, Poland, 40-600
    • GSK Investigational Site
  • Ostrowiec Świętokrzyski, Poland, 27-400
    • GSK Investigational Site
  • Płock, Poland, 09-407
    • GSK Investigational Site
  • Tarnów, Poland, 33-100
    • GSK Investigational Site
• Spain
  • Barcelona, Spain, 08017
    • GSK Investigational Site
  • Barcelona, Spain, 08540
    • GSK Investigational Site
  • Benalmádena, Spain, 29631
    • GSK Investigational Site
  • Madrid, Spain, 28041
    • GSK Investigational Site
  • Madrid, Spain, 28040
    • GSK Investigational Site
  • Madrid, Spain, 28031
    • GSK Investigational Site
  • Marbella, Spain, 29603
    • GSK Investigational Site
  • Pozuelo de AlarcOn Madr, Spain, 28223
    • GSK Investigational Site
• Thailand
  • Pathum Thani, Thailand, 12120
    • GSK Investigational Site
• United Kingdom
  • Bebington, United Kingdom, CH63 9JP
    • GSK Investigational Site
  • Cambridgeshire, United Kingdom, CB7 5JD
    • GSK Investigational Site
  • Corby, United Kingdom, NN17 2UR
    • GSK Investigational Site
  • Greater Manchester, United Kingdom, OL6 6HD
    • GSK Investigational Site
  • Guisborough, United Kingdom, TS14 7DJ
    • GSK Investigational Site
  • Hounslow, United Kingdom, TW3 3EL
    • GSK Investigational Site
  • Rhyl, United Kingdom, LL18 4HZ
    • GSK Investigational Site
  • Uttoxeter, United Kingdom, ST14 5JX
    • GSK Investigational Site
• United States
  • California
    • North Hollywood, California, United States, 91606-3287
      • GSK Investigational Site
    • San Mateo, California, United States, 94403
      • GSK Investigational Site
  • Florida
    • Aventura, Florida, United States, 33180
      • GSK Investigational Site
    • Clearwater, Florida, United States, 33756
      • GSK Investigational Site
    • DeLand, Florida, United States, 32720
      • GSK Investigational Site
    • Miami, Florida, United States, 33173
      • GSK Investigational Site
    • Miami, Florida, United States, 33144
      • GSK Investigational Site
    • Miami, Florida, United States, 33155
      • GSK Investigational Site
    • Naples, Florida, United States, 34102
      • GSK Investigational Site
    • Plantation, Florida, United States, 33317
      • GSK Investigational Site
    • Winter Park, Florida, United States, 32789
      • GSK Investigational Site
  • Georgia
    • Rincon, Georgia, United States, 31326
      • GSK Investigational Site
    • Stonecrest, Georgia, United States, 30038
      • GSK Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • GSK Investigational Site
    • Owensboro, Kentucky, United States, 42301
      • GSK Investigational Site
  • Massachusetts
    • Fall River, Massachusetts, United States, 02723
      • GSK Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • GSK Investigational Site
    • Minneota, Minnesota, United States, 56001
      • GSK Investigational Site
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • GSK Investigational Site
  • Missouri
    • Columbia, Missouri, United States, 65203
      • GSK Investigational Site
  • Nevada
    • Henderson, Nevada, United States, 89052
      • GSK Investigational Site
  • New Jersey
    • Jersey City, New Jersey, United States, 07306
      • GSK Investigational Site
    • Riverdale, New Jersey, United States, 07457
      • GSK Investigational Site
  • New York
    • Brooklyn, New York, United States, 11220
      • GSK Investigational Site
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27104
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • GSK Investigational Site
    • Dublin, Ohio, United States, 43016
      • GSK Investigational Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15241
      • GSK Investigational Site
    • Pottstown, Pennsylvania, United States, 19464
      • GSK Investigational Site
  • South Carolina
    • Rock Hill, South Carolina, United States, 29732
      • GSK Investigational Site
    • Spartanburg, South Carolina, United States, 29303
      • GSK Investigational Site
    • Union, South Carolina, United States, 29379
      • GSK Investigational Site
  • Texas
    • Sugar Land, Texas, United States, 77479
      • GSK Investigational Site
    • Tomball, Texas, United States, 77375
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Salbutamol Test Arm	Drug: Salbutamol HFA-152a; 100 μg (ex-valve) at 30-second intervals per actuation
Active Comparator: Salbutamol Reference Arm	Drug: Salbutamol HFA-134a; 100 microgram (μg) (ex-valve) at 30-second intervals per actuation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Adverse Events (AEs)	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Serious Adverse Events (SAEs)		Up to 3 months
Absolute values of serum potassium (milligrams per decilitre)		Up to 3 months
Absolute value of haematology parameter: Platelet count (cells per microliter)		Up to 3 months
Absolute value of haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)		Up to 3 months
Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)		Up to 3 months
Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)		Up to 3 months
Absolute values of haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)		Up to 3 months
Absolute values of Clinical Chemistry parameters: Glucose (non-fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)		Up to 3 months
Absolute value of routine urinalysis: potential of hydrogen (pH)		Up to 3 months
Number of participants with abnormal urinalysis dipstick results: glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase		Up to 3 months
Change from baseline in haematology parameter: Platelet count (cells per microliter)		Baseline (Day 1) and up to 3 months
Change from baseline in haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)		Baseline (Day 1) and up to 3 months
Change from baseline in haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)		Baseline (Day 1) and up to 3 months
Change from baseline in haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)		Baseline (Day 1) and up to 3 months
Change from baseline in haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)		Baseline (Day 1) and up to 3 months
Change from baseline in haematology parameters: haematocrit (Proportion of red blood cells in blood)		Baseline (Day 1) and up to 3 months
Change from baseline in Clinical Chemistry parameters: Glucose (non-fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)		Baseline (Day 1) and up to 3 months
Change from baseline in routine urinalysis: pH		Baseline (Day 1) and up to 3 months
Change from baseline for 12 Lead ECGs in QTc (milliseconds)		Baseline (Day 1) and up to 3 months
Change from baseline for pre-bronchodilator Forced expiratory volume in 1 second (FEV1)		Baseline (Day 1) and up to 3 months
Absolute Values of Minimum serum potassium (milliequivalents per litre [mEq/L])		Up to 3 months
Change from baseline in serum potassium (milligrams per decilitre)		Baseline (Day 1) and up to 3 months
Absolute values of haematology parameter: Reticulocytes (Percentage of reticulocytes)		Up to 3 months
Absolute values of haematology parameter: haemoglobin (Hgb) (grams per decilitre)		Up to 3 months
Absolute values of haematology parameter: haematocrit (Proportion of red blood cells in blood)		Up to 3 months
Absolute values of Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase, Alanine aminotransferase/serum glutamic-pyruvic transaminase, Alkaline phosphatase, Creatine phosphokinase (International Units per litre)		Up to 3 months
Change from baseline in haematology parameter: Reticulocytes (Percentage of reticulocytes)		Baseline (Day 1) and up to 3 months
Change from baseline in haematology parameter: haemoglobin (Hgb) (grams per decilitre)		Baseline (Day 1) and up to 3 months
Change from baseline in Aspartate aminotransferase/ serum glutamic-oxaloacetic transaminase,Alanine aminotransferase/serum glutamic-pyruvic transaminase, Alkaline phosphatase, Creatine phosphokinase (International Units per litre)		Baseline (Day 1) and up to 3 months
Absolute values for vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [millimeters of mercury (mm Hg)]		Up to 3 months
Absolute values for vital sign: pulse rate [beats per min (bpm)]		Up to 3 months
Change from baseline in vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [millimeters of mercury (mm Hg)]		Baseline (Day 1) and up to 3 months
Change from baseline in vital sign: pulse rate [beats per min (bpm)]		Baseline (Day 1) and up to 3 months
Absolute values for 12 Lead Electrocardiograms (ECGs) in Corrected QT interval (QTc) (milliseconds)		Up to 3 months
Absolute values for heart rate [beats per min (bpm)]		Up to 3 months
Change from baseline for heart rate [beats per min (bpm)]		Baseline (Day 1) and up to 3 months
Change from baseline in Asthma Control Questionnaire (ACQ-6) score	ACQ-6 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)) and a question on rescue bronchodilator use. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma.	Baseline (Day 1) and up to 3 months

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2024
• Primary Completion (Actual): September 2, 2025
• Study Completion (Actual): September 2, 2025

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; MDI; Salbutamol; HFA-134a; HFA-152a
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Reproductive Control Agents; Anesthetics; Central Nervous System Depressants; Neurotransmitter Agents; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol; Norflurane
• Other Study ID Numbers: 220735; 2023-509001-76-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No