Last updated: 07/02/2025 15:01:05

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

GSK study ID
220735
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Recruitment complete
Recruitment complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of participants with Adverse Events (AEs)

Timeframe: Up to 3 months

Secondary outcomes:

Number of participants with Serious Adverse Events (SAEs)

Timeframe: Up to 3 months

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

Timeframe: Up to 3 months

Absolute values of serum potassium (milligrams per decilitre)

Timeframe: Up to 3 months

Change from baseline in serum potassium (milligrams per decilitre)

Timeframe: Baseline (Day 1) and up to 3 months

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

Timeframe: Up to 3 months

Absolute value of haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)

Timeframe: Up to 3 months

Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)

Timeframe: Up to 3 months

Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)

Timeframe: Up to 3 months

Absolute values of haematology parameter: Reticulocytes (Percentage of reticulocytes)

Timeframe: Up to 3 months

Absolute values of haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)

Timeframe: Up to 3 months

Absolute values of haematology parameter: haemoglobin (Hgb) (grams per decilitre)

Timeframe: Up to 3 months

Absolute values of haematology parameter: haematocrit (Proportion of red blood cells in blood)

Timeframe: 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)

Timeframe: 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)

Timeframe: Up to 3 months

Absolute value of routine urinalysis: potential of hydrogen (pH)

Timeframe: Up to 3 months

Number of participants with abnormal urinalysis dipstick results: glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase

Timeframe: Up to 3 months

Change from baseline in haematology parameter: Platelet count (cells per microliter)

Timeframe: Baseline (Day 1) and up to 3 months

Change from baseline in haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)

Timeframe: Baseline (Day 1) and up to 3 months

Change from baseline in haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)

Timeframe: Baseline (Day 1) and up to 3 months

Change from baseline in haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)

Timeframe: Baseline (Day 1) and up to 3 months

Change from baseline in haematology parameter: Reticulocytes (Percentage of reticulocytes)

Timeframe: Baseline (Day 1) and up to 3 months

Change from baseline in haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)

Timeframe: Baseline (Day 1) and up to 3 months

Change from baseline in haematology parameter: haemoglobin (Hgb) (grams per decilitre)

Timeframe: Baseline (Day 1) and up to 3 months

Change from baseline in haematology parameters: haematocrit (Proportion of red blood cells in blood)

Timeframe: 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)

Timeframe: 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)

Timeframe: Baseline (Day 1) and up to 3 months

Change from baseline in routine urinalysis: pH

Timeframe: 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)]

Timeframe: Up to 3 months

Absolute values for vital sign: pulse rate [beats per min (bpm)]

Timeframe: Up to 3 months

Change from baseline in vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [millimeters of mercury (mm Hg)]

Timeframe: Baseline (Day 1) and up to 3 months

Change from baseline in vital sign: pulse rate [beats per min (bpm)]

Timeframe: Baseline (Day 1) and up to 3 months

Absolute values for 12 Lead Electrocardiograms (ECGs) in Corrected QT interval (QTc) (milliseconds)

Timeframe: Up to 3 months

Absolute values for heart rate [beats per min (bpm)]

Timeframe: Up to 3 months

Change from baseline for 12 Lead ECGs in QTc (milliseconds)

Timeframe: Baseline (Day 1) and up to 3 months

Change from baseline for heart rate [beats per min (bpm)]

Timeframe: Baseline (Day 1) and up to 3 months

Change from baseline in Asthma Control Questionnaire (ACQ-6) score

Timeframe: Baseline (Day 1) and up to 3 months

Change from baseline for pre-bronchodilator Forced expiratory volume in 1 second (FEV1)

Timeframe: Baseline (Day 1) and up to 3 months

Interventions:
  • Drug: Salbutamol HFA-134a
  • Drug: Salbutamol HFA-152a
  • Enrollment:
    412
    Primary completion date:
    2025-05-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    salbutamol
    Collaborators
    Not applicable
    Study date(s)
    May 2024 to September 2025
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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:
    • 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    AMIENS CEDEX 1, France, 80054
    Status
    Recruiting
    Location
    GSK Investigational Site
    Asheville, NC, United States, 28803
    Status
    Recruiting
    Location
    GSK Investigational Site
    Bialystok, Poland, 15-010
    Status
    Recruiting
    Location
    GSK Investigational Site
    Brooklyn, NY, United States, 11220
    Status
    Recruiting
    Location
    GSK Investigational Site
    Cannes, France, 06614
    Status
    Recruiting
    Location
    GSK Investigational Site
    Columbia, MO, United States, 65203
    Status
    Recruiting
    Location
    GSK Investigational Site
    Corby, United Kingdom, NN17 2UR
    Status
    Recruiting
    Location
    GSK Investigational Site
    DuBois, PA, United States, 15801
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Dublin, OH, United States, 43016
    Status
    Recruiting
    Location
    GSK Investigational Site
    Elblag, Poland, 82-300
    Status
    Recruiting
    Location
    GSK Investigational Site
    Spartanburg, SC, United States, 29303
    Status
    Recruiting
    Location
    GSK Investigational Site
    Hounslow, United Kingdom, TW3 3EL
    Status
    Recruiting
    Location
    GSK Investigational Site
    Jersey City, NJ, United States, 07306
    Status
    Recruiting
    Location
    GSK Investigational Site
    Louisville, KY, United States, 40217
    Status
    Recruiting
    Location
    GSK Investigational Site
    Milano, Italy, 20162
    Status
    Study Complete
    Location
    GSK Investigational Site
    Napoli, Italy, 80131
    Status
    Recruiting
    Location
    GSK Investigational Site
    Olive Branch, MS, United States, 38654
    Status
    Recruiting
    Location
    GSK Investigational Site
    Ottawa, ON, Canada, K1H 1E4
    Status
    Recruiting
    Location
    GSK Investigational Site
    Padova, Italy, 35128
    Status
    Recruiting
    Location
    GSK Investigational Site
    Philadelphia, PA, United States, 19107
    Status
    Recruiting
    Location
    GSK Investigational Site
    Pittsburgh, PA, United States, 15241
    Status
    Recruiting
    Location
    GSK Investigational Site
    Poitiers, France, 86021
    Status
    Recruiting
    Location
    GSK Investigational Site
    QUEBEC, QC, Canada, G1V 4W2
    Status
    Recruiting
    Location
    GSK Investigational Site
    Quebec, QC, Canada, G1W 4R4
    Status
    Recruiting
    Location
    GSK Investigational Site
    Rhyl, United Kingdom, LL18 4HZ
    Status
    Recruiting
    Location
    GSK Investigational Site
    Rincon, GA, United States, 31326
    Status
    Study Complete
    Location
    GSK Investigational Site
    Riverdale, NJ, United States, 07457
    Status
    Recruiting
    Location
    GSK Investigational Site
    Cambridgeshire, United Kingdom, CB7 5JD
    Status
    Recruiting
    Location
    GSK Investigational Site
    Strasbourg, France, 67091
    Status
    Recruiting
    Location
    GSK Investigational Site
    Tarnow, Poland, 33-100
    Status
    Recruiting
    Location
    GSK Investigational Site
    Tomball, TX, United States, 77375
    Status
    Recruiting
    Location
    GSK Investigational Site
    Windsor, ON, Canada, N8X 2G1
    Status
    Recruiting
    Location
    GSK Investigational Site
    BenalmAdena, Spain, 29631
    Status
    Recruiting
    Location
    GSK Investigational Site
    Madrid, Spain, 28031
    Status
    Recruiting
    Location
    GSK Investigational Site
    Marbella, Spain, 29603
    Status
    Recruiting
    Location
    GSK Investigational Site
    Plantation, FL, United States, 33317
    Status
    Recruiting
    Location
    GSK Investigational Site
    Pottstown, PA, United States, 19464
    Status
    Study Complete
    Location
    GSK Investigational Site
    Stonecrest, GA, United States, 30038
    Status
    Recruiting
    Location
    GSK Investigational Site
    Ajax, ON, Canada, L1S 2J5
    Status
    Recruiting
    Location
    GSK Investigational Site
    Bielsko-Biala, Poland, 43-300
    Status
    Recruiting
    Location
    GSK Investigational Site
    Firenze, Italy, 50134
    Status
    Recruiting
    Location
    GSK Investigational Site
    Medford, OR, United States, 97504
    Status
    Recruiting
    Location
    GSK Investigational Site
    Uttoxeter, United Kingdom, ST14 5JX
    Status
    Recruiting
    Location
    GSK Investigational Site
    Winston Salem, NC, United States, 27104
    Status
    Recruiting
    Location
    GSK Investigational Site
    Alexandroupolis, Greece, 68100
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Argenteuil cedex, France, 95100
    Status
    Recruiting
    Location
    GSK Investigational Site
    Greater Manchester, United Kingdom, OL6 6HD
    Status
    Recruiting
    Location
    GSK Investigational Site
    Aventura, FL, United States, 33180
    Status
    Recruiting
    Location
    GSK Investigational Site
    Barcelona, Spain, 08017
    Status
    Recruiting
    Location
    GSK Investigational Site
    Bebington, United Kingdom, CH63 9JP
    Status
    Recruiting
    Location
    GSK Investigational Site
    Brampton, ON, Canada, L6T 0G1
    Status
    Recruiting
    Location
    GSK Investigational Site
    Buenos Aires, Argentina, C1425BEN
    Status
    Study Complete
    Location
    GSK Investigational Site
    Barcelona, Spain, 08540
    Status
    Recruiting
    Location
    GSK Investigational Site
    Cincinnati, OH, United States, 45231
    Status
    Recruiting
    Location
    GSK Investigational Site
    Ciudad de Panama, Panama, 7099
    Status
    Recruiting
    Location
    GSK Investigational Site
    Clearwater, FL, United States, 33756
    Status
    Study Complete
    Location
    GSK Investigational Site
    CrEteil cedex, France, 94010
    Status
    Recruiting
    Location
    GSK Investigational Site
    Foggia, Italy, 71100
    Status
    Recruiting
    Location
    GSK Investigational Site
    Guisborough, United Kingdom, TS14 7DJ
    Status
    Recruiting
    Location
    GSK Investigational Site
    Chorzow, Poland, 41-500
    Status
    Recruiting
    Location
    GSK Investigational Site
    Katowice, Poland, 40-600
    Status
    Recruiting
    Location
    GSK Investigational Site
    Larissa, Greece, 41110
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28040
    Status
    Recruiting
    Location
    GSK Investigational Site
    Madrid, Spain, 28041
    Status
    Recruiting
    Location
    GSK Investigational Site
    Minnesota, MN, United States, 56001
    Status
    Recruiting
    Location
    GSK Investigational Site
    Mendoza, Argentina, M5500CCG
    Status
    Recruiting
    Location
    GSK Investigational Site
    Miami, FL, United States, 33155
    Status
    Recruiting
    Location
    GSK Investigational Site
    Minneapolis, MN, United States, 55402
    Status
    Recruiting
    Location
    GSK Investigational Site
    Cagliari, Italy, 09042
    Status
    Recruiting
    Location
    GSK Investigational Site
    Ostrowiec Swietokrzyski, Poland, 27-400
    Status
    Recruiting
    Location
    GSK Investigational Site
    Owensboro, KY, United States, 42301
    Status
    Recruiting
    Location
    GSK Investigational Site
    Panama, Panama
    Status
    Recruiting
    Location
    GSK Investigational Site
    Panama, Panama, 7002
    Status
    Recruiting
    Location
    GSK Investigational Site
    Plock, Poland, 09-407
    Status
    Recruiting
    Location
    GSK Investigational Site
    Pontoise, France, 95303
    Status
    Recruiting
    Location
    GSK Investigational Site
    Pozuelo de AlarcOn Madr, Spain, 28223
    Status
    Recruiting
    Location
    GSK Investigational Site
    Rock Hill, SC, United States, 29732
    Status
    Recruiting
    Location
    GSK Investigational Site
    Roma, Italy
    Status
    Study Complete
    Location
    GSK Investigational Site
    Thessaloniki, Greece, 57010
    Status
    Recruiting
    Location
    GSK Investigational Site
    Torino, Italy, 10128
    Status
    Recruiting
    Location
    GSK Investigational Site
    Toronto, ON, Canada, M9V 4B4
    Status
    Recruiting
    Location
    GSK Investigational Site
    Union, SC, United States, 29379
    Status
    Recruiting
    Location
    GSK Investigational Site
    Tradate VA, Italy, 21100
    Status
    Recruiting
    Location
    GSK Investigational Site
    Verona, Italy, 37134
    Status
    Study Complete
    Location
    GSK Investigational Site
    Winter Park, FL, United States, 32789
    Status
    Study Complete
    Location
    GSK Investigational Site
    Coffs Harbour, NSW, Australia, 2450
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kanwal, NSW, Australia, 2259
    Status
    Recruiting
    Location
    GSK Investigational Site
    Spearwood, WA, Australia, 6163
    Status
    Study Complete
    Location
    GSK Investigational Site
    Botany, NSW, Australia, 2019
    Status
    Study Complete
    Location
    GSK Investigational Site
    La Plata, Argentina, 1900
    Status
    Recruiting
    Location
    GSK Investigational Site
    Deland, FL, United States, 32720
    Status
    Study Complete
    Location
    GSK Investigational Site
    Athens, Greece, 15669
    Status
    Study Complete
    Location
    GSK Investigational Site
    Miami, FL, United States, 33173
    Status
    Recruiting
    Location
    GSK Investigational Site
    Naples, FL, United States, 34102
    Status
    Recruiting
    Location
    GSK Investigational Site
    North Hollywood, CA, United States, 91606-3287
    Status
    Recruiting
    Location
    GSK Investigational Site
    San Mateo, CA, United States, 94403
    Status
    Recruiting
    Location
    GSK Investigational Site
    Santiago de Compostela, Spain, 15706
    Status
    Recruiting
    Location
    GSK Investigational Site
    Henderson, NV, United States, 89052
    Status
    Recruiting
    Location
    GSK Investigational Site
    BUENOS AIRES, Argentina, C1426ABP
    Status
    Recruiting
    Location
    GSK Investigational Site
    Bellingham, WA, United States, 98225
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Iloilo, Philippines, 5000
    Status
    Recruiting
    Location
    GSK Investigational Site
    Iloilo City, Philippines, 5000
    Status
    Recruiting
    Location
    GSK Investigational Site
    Pathumthani, Thailand, 12120
    Status
    Recruiting
    Location
    GSK Investigational Site
    Sugar Land, TX, United States, 77479
    Status
    Recruiting
    Location
    GSK Investigational Site
    Miami, FL, United States, 33144
    Status
    Recruiting
    Location
    GSK Investigational Site
    Fall River, MA, United States, 02723
    Status
    Recruiting
    Location
    GSK Investigational Site
    Farmington Hills, MI, United States, 48336
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Colorado Springs, CO, United States, 80909
    Status
    Recruiting

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Recruitment complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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