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
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    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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