Last updated: 02/24/2026 18:10:12

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
Completed
Completed
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:
477
Observational study model:
Not applicable
Primary completion date:
2025-02-09
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
Study Complete
Location
GSK Investigational Site
Asheville, NC, Unmapped, 28803
Status
Study Complete
Location
GSK Investigational Site
Bialystok, Poland, 15-010
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, NY, Unmapped, 11220
Status
Study Complete
Location
GSK Investigational Site
Cannes, France, 06614
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Columbia, MO, Unmapped, 65203
Status
Study Complete
Location
GSK Investigational Site
Corby, Unmapped, NN17 2UR
Status
Study Complete
Location
GSK Investigational Site
DuBois, PA, Unmapped, 15801
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Dublin, OH, Unmapped, 43016
Status
Study Complete
Location
GSK Investigational Site
Elblag, Poland, 82-300
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, SC, Unmapped, 29303
Status
Study Complete
Location
GSK Investigational Site
Hounslow, Unmapped, TW3 3EL
Status
Study Complete
Location
GSK Investigational Site
Jersey City, NJ, Unmapped, 07306
Status
Study Complete
Location
GSK Investigational Site
Louisville, KY, Unmapped, 40217
Status
Study Complete
Location
GSK Investigational Site
Milano, Italy, 20162
Status
Study Complete
Location
GSK Investigational Site
Napoli, Italy, 80131
Status
Study Complete
Location
GSK Investigational Site
Olive Branch, MS, Unmapped, 38654
Status
Study Complete
Location
GSK Investigational Site
Ottawa, ON, Canada, K1H 1E4
Status
Study Complete
Location
GSK Investigational Site
Padova, Italy, 35128
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, PA, Unmapped, 19107
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, PA, Unmapped, 15241
Status
Study Complete
Location
GSK Investigational Site
Poitiers, France, 86021
Status
Study Complete
Location
GSK Investigational Site
QUEBEC, QC, Canada, G1V 4W2
Status
Study Complete
Location
GSK Investigational Site
Quebec, QC, Canada, G1W 4R4
Status
Study Complete
Location
GSK Investigational Site
Rhyl, Unmapped, LL18 4HZ
Status
Study Complete
Location
GSK Investigational Site
Rincon, GA, Unmapped, 31326
Status
Study Complete
Location
GSK Investigational Site
Riverdale, NJ, Unmapped, 07457
Status
Study Complete
Location
GSK Investigational Site
Cambridgeshire, Unmapped, CB7 5JD
Status
Study Complete
Location
GSK Investigational Site
Strasbourg, France, 67091
Status
Study Complete
Location
GSK Investigational Site
Tarnow, Poland, 33-100
Status
Study Complete
Location
GSK Investigational Site
Tomball, TX, Unmapped, 77375
Status
Study Complete
Location
GSK Investigational Site
Windsor, ON, Canada, N8X 2G1
Status
Study Complete
Location
GSK Investigational Site
BenalmAdena, Spain, 29631
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28031
Status
Study Complete
Location
GSK Investigational Site
Marbella, Spain, 29603
Status
Study Complete
Location
GSK Investigational Site
Plantation, FL, Unmapped, 33317
Status
Study Complete
Location
GSK Investigational Site
Pottstown, PA, Unmapped, 19464
Status
Study Complete
Location
GSK Investigational Site
Stonecrest, GA, Unmapped, 30038
Status
Study Complete
Location
GSK Investigational Site
Ajax, ON, Canada, L1S 2J5
Status
Study Complete
Location
GSK Investigational Site
Bielsko-Biala, Poland, 43-300
Status
Study Complete
Location
GSK Investigational Site
Firenze, Italy, 50134
Status
Study Complete
Location
GSK Investigational Site
Medford, OR, Unmapped, 97504
Status
Study Complete
Location
GSK Investigational Site
Uttoxeter, Unmapped, ST14 5JX
Status
Study Complete
Location
GSK Investigational Site
Winston Salem, NC, Unmapped, 27104
Status
Study Complete
Location
GSK Investigational Site
Alexandroupolis, Greece, 68100
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Argenteuil cedex, France, 95100
Status
Study Complete
Location
GSK Investigational Site
Greater Manchester, Unmapped, OL6 6HD
Status
Study Complete
Location
GSK Investigational Site
Aventura, FL, Unmapped, 33180
Status
Study Complete
Location
GSK Investigational Site
Barcelona, Spain, 08017
Status
Study Complete
Location
GSK Investigational Site
Bebington, Unmapped, CH63 9JP
Status
Study Complete
Location
GSK Investigational Site
Brampton, ON, Canada, L6T 0G1
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Argentina, C1425BEN
Status
Study Complete
Location
GSK Investigational Site
Barcelona, Spain, 08540
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, OH, Unmapped, 45231
Status
Study Complete
Location
GSK Investigational Site
Ciudad de Panama, Panama, 7099
Status
Study Complete
Location
GSK Investigational Site
Clearwater, FL, Unmapped, 33756
Status
Study Complete
Location
GSK Investigational Site
CrEteil cedex, France, 94010
Status
Study Complete
Location
GSK Investigational Site
Foggia, Italy, 71100
Status
Study Complete
Location
GSK Investigational Site
Guisborough, Unmapped, TS14 7DJ
Status
Study Complete
Location
GSK Investigational Site
Chorzow, Poland, 41-500
Status
Study Complete
Location
GSK Investigational Site
Katowice, Poland, 40-600
Status
Study Complete
Location
GSK Investigational Site
Larissa, Greece, 41110
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28040
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28041
Status
Study Complete
Location
GSK Investigational Site
Minnesota, MN, Unmapped, 56001
Status
Study Complete
Location
GSK Investigational Site
Mendoza, Argentina, M5500CCG
Status
Study Complete
Location
GSK Investigational Site
Miami, FL, Unmapped, 33155
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, MN, Unmapped, 55402
Status
Study Complete
Location
GSK Investigational Site
Cagliari, Italy, 09042
Status
Study Complete
Location
GSK Investigational Site
Ostrowiec Swietokrzyski, Poland, 27-400
Status
Study Complete
Location
GSK Investigational Site
Owensboro, KY, Unmapped, 42301
Status
Study Complete
Location
GSK Investigational Site
Panama, Panama
Status
Study Complete
Location
GSK Investigational Site
Plock, Poland, 09-407
Status
Study Complete
Location
GSK Investigational Site
Pontoise, France, 95303
Status
Study Complete
Location
GSK Investigational Site
Pozuelo de AlarcOn Madr, Spain, 28223
Status
Study Complete
Location
GSK Investigational Site
Rock Hill, SC, Unmapped, 29732
Status
Study Complete
Location
GSK Investigational Site
Roma, Italy
Status
Study Complete
Location
GSK Investigational Site
Thessaloniki, Greece, 57010
Status
Study Complete
Location
GSK Investigational Site
Torino, Italy, 10128
Status
Study Complete
Location
GSK Investigational Site
Toronto, ON, Canada, M9V 4B4
Status
Study Complete
Location
GSK Investigational Site
Union, SC, Unmapped, 29379
Status
Study Complete
Location
GSK Investigational Site
Tradate VA, Italy, 21100
Status
Study Complete
Location
GSK Investigational Site
Verona, Italy, 37134
Status
Study Complete
Location
GSK Investigational Site
Winter Park, FL, Unmapped, 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
Study Complete
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
Study Complete
Location
GSK Investigational Site
Deland, FL, Unmapped, 32720
Status
Study Complete
Location
GSK Investigational Site
Athens, Greece, 15669
Status
Study Complete
Location
GSK Investigational Site
Miami, FL, Unmapped, 33173
Status
Study Complete
Location
GSK Investigational Site
Naples, FL, Unmapped, 34102
Status
Study Complete
Location
GSK Investigational Site
North Hollywood, CA, Unmapped, 91606-3287
Status
Study Complete
Location
GSK Investigational Site
San Mateo, CA, Unmapped, 94403
Status
Study Complete
Location
GSK Investigational Site
Santiago de Compostela, Spain, 15706
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Henderson, NV, Unmapped, 89052
Status
Study Complete
Location
GSK Investigational Site
BUENOS AIRES, Argentina, C1426ABP
Status
Study Complete
Location
GSK Investigational Site
Bellingham, WA, Unmapped, 98225
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Iloilo, Philippines, 5000
Status
Study Complete
Location
GSK Investigational Site
Iloilo City, Philippines, 5000
Status
Study Complete
Location
GSK Investigational Site
Pathumthani, Thailand, 12120
Status
Study Complete
Location
GSK Investigational Site
Sugar Land, TX, Unmapped, 77479
Status
Study Complete
Location
GSK Investigational Site
Miami, FL, Unmapped, 33144
Status
Study Complete
Location
GSK Investigational Site
Fall River, MA, Unmapped, 02723
Status
Study Complete
Location
GSK Investigational Site
Farmington Hills, MI, Unmapped, 48336
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Colorado Springs, CO, Unmapped, 80909
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Houston, TX, Unmapped, 77018
Status
Terminated/Withdrawn

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Completed
Actual primary completion date
2025-02-09
Actual study completion date
2025-02-09

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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