Last updated: 08/12/2026 09:31:47

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 459 days

Secondary outcomes:

Number of participants with Serious Adverse Events (SAEs)

Timeframe: Up to 459 days

Absolute Values of Minimum serum potassium

Timeframe: Up to Week 13 (Follow up)

Absolute values of serum potassium at each assessed visit

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Change from Baseline (CFB) in serum potassium at each assessed visit

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Absolute values of hematology parameter: Erythrocytes

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Change from Baseline of hematology parameter: Erythrocytes

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Absolute values of hematology parameter: Mean Corpuscular Volume (MCV)

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Change from Baseline of hematology parameter: MCV

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Absolute values of hematology parameter: Mean Corpuscular hemoglobin (MCH)

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Change from Baseline of hematology parameter: MCH

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Absolute values of hematology parameter: Percentage of Reticulocytes

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Change from Baseline of hematology parameter: Percentage of Reticulocytes

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Absolute values of hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and platelets

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Change from Baseline of hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and platelets

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Absolute values of hematology parameter: hemoglobin (Hgb)

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Change from Baseline of hematology parameter: hemoglobin (Hgb)

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Absolute values of hematology parameter: hematocrit

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Change from Baseline of hematology parameter: hematocrit

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Absolute values of Clinical Chemistry parameters: Calcium, Potassium, Sodium, Urea and Glucose (non-fasting)

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Change from Baseline of Clinical Chemistry parameters: Calcium, Potassium, Sodium, Urea and Glucose (non-fasting)

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Absolute values of Clinical Chemistry parameters: Direct Bilirubin Total Bilirubin and Creatinine

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Change from Baseline of Clinical Chemistry parameters: Direct Bilirubin Total Bilirubin and Creatinine

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Absolute values of Clinical Chemistry Parameters: Alkaline phosphatase (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and Creatine phosphokinase (CPK)

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Change from Baseline of Clinical Chemistry Parameters: Alkaline phosphatase (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and Creatine phosphokinase (CPK)

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

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

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Change from Baseline of urinalysis parameter: potential of hydrogen (pH)

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Absolute value of urinalysis parameter: Specific Gravity

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Change from Baseline of urinalysis parameter: Specific Gravity

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Number of participants with worst-case urinalysis results post-baseline relative to baseline urinalysis dipstick results: Occult blood, protein, urobilinogen, bilirubin, glucose, ketones, leukocyte esterase and nitrite

Timeframe: Up to Week 13 (Follow up)

Absolute values for vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Change from Baseline in vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Absolute values for vital signs: pulse rate

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Change from Baseline in vital signs: pulse rate

Timeframe: Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13

Absolute values for 12 Lead Electrocardiograms (ECGs) in QT Interval corrected by Fridericia’s formula (QTcF)

Timeframe: Baseline (Day 1, mean of the pre-dose), Weeks 1, 4, 8, 12 and 13

Change from Baseline for 12 Lead ECGs in QTcF

Timeframe: Baseline (Day 1, mean of the pre-dose), Weeks 1, 4, 8, 12 and 13

Absolute values for heart rate

Timeframe: Baseline (Day 1, mean of the pre-dose), Weeks 1, 4, 8, 12 and 13

Change from Baseline in heart rate

Timeframe: Baseline (Day 1, mean of the pre-dose), Weeks 1, 4, 8, 12 and 13

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

Timeframe: Baseline (Day 1, pre-dose) and Week 12

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

Timeframe: Baseline (Day 1, pre-dose) and Week 12

Interventions:
Drug: Salbutamol HFA-134a
Drug: Salbutamol HFA-152a
Enrollment:
450
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, United States, 28803
Status
Study Complete
Location
GSK Investigational Site
Bialystok, Poland, 15-010
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, NY, United States, 11220
Status
Study Complete
Location
GSK Investigational Site
Cannes, France, 06614
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Columbia, MO, United States, 65203
Status
Study Complete
Location
GSK Investigational Site
Corby, United Kingdom, NN17 2UR
Status
Study Complete
Location
GSK Investigational Site
DuBois, PA, United States, 15801
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Dublin, OH, United States, 43016
Status
Study Complete
Location
GSK Investigational Site
Elblag, Poland, 82-300
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, SC, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Hounslow, United Kingdom, TW3 3EL
Status
Study Complete
Location
GSK Investigational Site
Jersey City, NJ, United States, 07306
Status
Study Complete
Location
GSK Investigational Site
Louisville, KY, United States, 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, United States, 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, United States, 19107
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, PA, United States, 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, United Kingdom, LL18 4HZ
Status
Study Complete
Location
GSK Investigational Site
Rincon, GA, United States, 31326
Status
Study Complete
Location
GSK Investigational Site
Riverdale, NJ, United States, 07457
Status
Study Complete
Location
GSK Investigational Site
Cambridgeshire, United Kingdom, 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, United States, 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, United States, 33317
Status
Study Complete
Location
GSK Investigational Site
Pottstown, PA, United States, 19464
Status
Study Complete
Location
GSK Investigational Site
Stonecrest, GA, United States, 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, United States, 97504
Status
Study Complete
Location
GSK Investigational Site
Uttoxeter, United Kingdom, ST14 5JX
Status
Study Complete
Location
GSK Investigational Site
Winston Salem, NC, United States, 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, United Kingdom, OL6 6HD
Status
Study Complete
Location
GSK Investigational Site
Aventura, FL, United States, 33180
Status
Study Complete
Location
GSK Investigational Site
Barcelona, Spain, 08017
Status
Study Complete
Location
GSK Investigational Site
Bebington, United Kingdom, 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, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Ciudad de Panama, Panama, 7099
Status
Study Complete
Location
GSK Investigational Site
Clearwater, FL, United States, 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, United Kingdom, 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, United States, 56001
Status
Study Complete
Location
GSK Investigational Site
Mendoza, Argentina, M5500CCG
Status
Study Complete
Location
GSK Investigational Site
Miami, FL, United States, 33155
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, MN, United States, 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, United States, 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, United States, 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, United States, 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, 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
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, 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
Study Complete
Location
GSK Investigational Site
Naples, FL, United States, 34102
Status
Study Complete
Location
GSK Investigational Site
North Hollywood, CA, United States, 91606-3287
Status
Study Complete
Location
GSK Investigational Site
San Mateo, CA, United States, 94403
Status
Study Complete
Location
GSK Investigational Site
Santiago de Compostela, Spain, 15706
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Henderson, NV, United States, 89052
Status
Study Complete
Location
GSK Investigational Site
BUENOS AIRES, Argentina, C1426ABP
Status
Study Complete
Location
GSK Investigational Site
Bellingham, WA, United States, 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, United States, 77479
Status
Study Complete
Location
GSK Investigational Site
Miami, FL, United States, 33144
Status
Study Complete
Location
GSK Investigational Site
Fall River, MA, United States, 02723
Status
Study Complete
Location
GSK Investigational Site
Farmington Hills, MI, United States, 48336
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Colorado Springs, CO, United States, 80909
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Houston, TX, United States, 77018
Status
Terminated/Withdrawn

Study documents

Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

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

Plain language summaries

Summary of results in plain language
Available language(s): French (Canadian), French, Greek, Hiligaynon, Italian, Polish, Spanish (Argentina), Spanish (Panama), Spanish, Tagalog, Thai, English

Additional information about the trial

Additional information
Not applicable
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