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CompletedNCT06261957Updated Oct 6, 2026Results posted

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 Phase 3 interventional study of Salbutamol HFA-134a and Salbutamol HFA-152a in Asthma, sponsored by GlaxoSmithKline. Completed at 102 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Updated Oct 6, 2026Results postedEnrollment updated+4 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
471
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Asthma

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Keywords

  • Asthma
  • Salbutamol
  • MDI
  • HFA-152a
  • HFA-134a
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 471 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
471 participants (actual)

Study arms

  • Experimental
    Salbutamol HFA-152a MDI

    Participants with asthma received inhalation of 200 microgram (ug) (2\*100 ug) or as needed up to maximum 800 µg once daily Salbutamol HFA-152a (Test) via metered dose inhaler (MDI) suspension at 30 second intervals per actuation. Participants attended 5 On-treatment visits at Weeks 0 (Day 1), 1, 4, 8 \& 12 and a Follow-up visit at Week 13.

    Drug: Salbutamol HFA-152a

  • Active comparator
    Salbutamol HFA-134a MDI

    Participants with asthma received inhalation of 200 microgram (ug) (2\*100 ug) once daily plus as needed up to maximum 800 of µg Salbutamol HFA-134a (Reference) via metered dose inhaler (MDI) suspension at 30 second intervals per actuation. Participants attended 5 On-treatment visits at Weeks 0 (Day 1), 1, 4, 8 \& 12 and a Follow-up visit at Week 13.

    Drug: Salbutamol HFA-134a

Interventions

  • DrugSalbutamol HFA-134a

    100 microgram (μg) (ex-valve) at 30-second intervals per actuation

  • DrugSalbutamol HFA-152a

    100 μg (ex-valve) at 30-second intervals per actuation

06

What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Events (AEs) During Run-in Period

    An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

    Time frame: From Week -1 up to randomization (Day 1) during Run-in period

  2. Number of Participants With Adverse Events (AEs) During Treatment Period

    An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

    Time frame: From randomization (Day 1) up to Week 13 (Follow up) during treatment period

Secondary outcomes

  1. Number of Participants With Serious Adverse Events (SAEs) During Run-in Period

    SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), Is a suspected transmission of any infectious agent via an authorized medicinal product, other situations judged by physician, is associated with liver injury and impaired liver function. SAEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

    Time frame: From Week -1 up to randomization (Day 1) during Run-in period

  2. Number of Participants With Serious Adverse Events (SAEs) During Treatment Period

    SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), Is a suspected transmission of any infectious agent via an authorized medicinal product, other situations judged by physician, is associated with liver injury and impaired liver function. SAEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

    Time frame: From randomization (Day 1) up to Week 13 (Follow up) during treatment period

  3. Absolute Values of Minimum Serum Potassium

    Blood samples were collected to analyze minimum serum potassium.

    Time frame: Up to Week 13 (Follow up)

  4. Absolute Values of Serum Potassium at Each Assessed Visit

    Blood samples were collected to analyze the serum potassium. Baseline value was defined as the pre-dose value on Day 1.

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

  5. Change From Baseline (CFB) in Serum Potassium at Each Assessed Visit

    Blood samples were collected to analyze the serum potassium. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  6. Absolute Values of Hematology Parameter: Erythrocytes

    Blood samples were collected to analyze the hematology parameter: Erythrocytes. Baseline value was defined as the pre-dose value on Day 1.

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

  7. Change From Baseline of Hematology Parameter: Erythrocytes

    Blood samples were collected to analyze the hematology parameter: Erythrocytes. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  8. Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)

    Blood samples were collected to analyze the hematology parameter: MCV. Baseline value was defined as the pre-dose value on Day 1.

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

  9. Change From Baseline of Hematology Parameter: MCV

    Blood samples were collected to analyze the hematology parameter: MCV. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  10. Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)

    Blood samples were collected to analyze the hematology parameter: MCH. Baseline value was defined as the pre-dose value on Day 1.

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

  11. Change From Baseline of Hematology Parameter: MCH

    Blood samples were collected to analyze the hematology parameter: MCH. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  12. Absolute Values of Hematology Parameter: Percentage of Reticulocytes

    Blood samples were collected to analyze the hematology parameter: Percentage of Reticulocytes. Baseline value was defined as the pre-dose value on Day 1.

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

  13. Change From Baseline of Hematology Parameter: Percentage of Reticulocytes

    Blood samples were collected to analyze the hematology parameter: Percentage of Reticulocytes. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  14. Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets

    Blood samples were collected to analyze the hematology parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and platelets. Baseline value was defined as the pre-dose value on Day 1.

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

  15. Change From Baseline of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets

    Blood samples were collected to analyze the hematology parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and platelets. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  16. Absolute Values of Hematology Parameter: Hemoglobin (Hgb)

    Blood samples were collected to analyze the hematology parameter: Hgb. Baseline value was defined as the pre-dose value on Day 1.

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

  17. Change From Baseline of Hematology Parameter: Hemoglobin (Hgb)

    Blood samples were collected to analyze the hematology parameter: Hgb. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  18. Absolute Values of Hematology Parameter: Hematocrit

    Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline value was defined as the pre-dose value on Day 1.

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

  19. Change From Baseline of Hematology Parameter: Hematocrit

    Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  20. Absolute Values of Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Urea and Glucose (Non-fasting)

    Blood samples were collected to analyze the Clinical Chemistry parameters: Calcium, Potassium, Sodium, Urea and Glucose (non-fasting). Baseline value was defined as the pre-dose value on Day 1.

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

  21. Change From Baseline of Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Urea and Glucose (Non-fasting)

    Blood samples were collected to analyze the Clinical Chemistry parameters: Calcium, Potassium, Sodium, Urea and Glucose (non-fasting). Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  22. Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin Total Bilirubin and Creatinine

    Blood samples were collected to analyze the Clinical Chemistry parameters: Direct Bilirubin Total Bilirubin and Creatinine. Baseline value was defined as the pre-dose value on Day 1.

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

  23. Change From Baseline of Clinical Chemistry Parameters: Direct Bilirubin Total Bilirubin and Creatinine

    Blood samples were collected to analyze the Clinical Chemistry parameters: Direct Bilirubin Total Bilirubin and Creatinine. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  24. Absolute Values of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)

    Blood samples were collected to analyze the Clinical Chemistry Parameters: ALP, ALT, AST and CPK. Baseline value was defined as the pre-dose value on Day 1.

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

  25. Change From Baseline of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)

    Blood samples were collected to analyze the Clinical Chemistry Parameters: ALP, ALT, AST and CPK. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  26. Absolute Value of Urinalysis Parameter: Potential of Hydrogen (pH)

    Urine samples were collected to analyze the pH. Baseline value was defined as the pre-dose value on Day 1.

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

  27. Change From Baseline of Urinalysis Parameter: Potential of Hydrogen (pH)

    Urine samples were collected to analyze the pH. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  28. Absolute Value of Urinalysis Parameter: Specific Gravity

    Urine samples were collected to analyze the Specific Gravity. Baseline value was defined as the pre-dose value on Day 1.

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

  29. Change From Baseline of Urinalysis Parameter: Specific Gravity

    Urine samples were collected to analyze the Specific Gravity. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  30. 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

    Urinalysis parameters were assessed using standard Urinalysis dipsticks and categorized according to the semi-quantitative scale provided by the test strip manufacturer (e.g.,negative, trace, 1+,2+,3+,where applicable). For each parameter, worsening from baseline was defined as a shift from a lower category (Increased to TRACE \& Non-hemolyzed TRACE), to a higher category (Increased to 1+, 2+, 3+, 4+, or 1, 2,4, 8 mg/dL \& hemolyzed TRACE), indicating a greater degree of abnormality. The worst post-baseline category observed during the study was compared with the baseline category to derive a worst-case post-baseline change classification. Participants were categorized according to the magnitude of worsening observed (e.g.,No Change/Decreased, Increase to TRACE, Increase to 1+, Increase to 2+, etc., as applicable for the parameter assessed). Values that trend towards 'normal' or a lower category (i.e. from 2+ to 1+) indicates a shift towards /return to a negative result.

    Time frame: Up to Week 13 (Follow up)

  31. Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    SDP and DBP measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Baseline value was defined as the pre-dose value on Day 1.

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

  32. Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    SBP and DBP measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  33. Absolute Values for Vital Signs: Pulse Rate

    Pulse rate measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Baseline value was defined as the pre-dose value on Day 1.

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

  34. Change From Baseline in Vital Signs: Pulse Rate

    Pulse rate measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  35. Absolute Values for 12 Lead Electrocardiograms (ECGs) in QT Interval Corrected by Fridericia's Formula (QTcF)

    A standard 12-lead ECG was obtained using an ECG machine that automatically measures QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures were averaged for QTc interval to derive one Baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline was defined as the mean of the triplicate 12-lead ECG measurement from the Day 1 assessment (pre-dose).

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

  36. Change From Baseline for 12 Lead ECGs in QTcF

    A standard 12-lead ECG was obtained using an ECG machine that automatically measures QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures were averaged for QTc interval to derive one Baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline was defined as the mean of the triplicate 12-lead ECG measurement from the Day 1 assessment (pre-dose). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  37. Absolute Values for Heart Rate

    A standard 12-lead ECG was obtained using an ECG machine that automatically measures HR. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures were averaged for HR to derive one Baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline was defined as the mean of the triplicate 12-lead ECG measurement from the Day 1 assessment (pre-dose).

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

  38. Change From Baseline in Heart Rate

    A standard 12-lead ECG was obtained using an ECG machine that automatically measures HR. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures were averaged for HR to derive one Baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline was defined as the mean of the triplicate 12-lead ECG measurement from the Day 1 assessment (pre-dose). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  39. Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score

    The ACQ-6 measures 6 attributes of asthma control and are measured with a participant completed questionnaire. ACQ-6 consists of six questionnaires about the frequency and/or severity of symptoms (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath, wheeze and rescue medication use). Each question was scored from zero (no impairment/limitation) to six (total impairment/ limitation). The ACQ-6 score is calculated as the mean of the scores from the six questionnaire items. ACQ-6 score ranges from 0 to 6 with higher scores indicate greater impairment. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

  40. Change From Baseline for Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

    Forced Expiratory Volume in one second (FEV1) is defined as the volume of air forcibly exhaled in one second. Pre-bronchodilator FEV1 measurements were taken by spirometry. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

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

07

Results

Posted Oct 6, 2026

Participant flow

Run-in Period (Week-1 to Day 1)
Participant flow — Run-in Period (Week-1 to Day 1)
MilestoneAll Enrolled ParticipantsSalbutamol HFA-152a MDISalbutamol HFA-134a MDI
Started47100
Completed45000
Not completed2100
Withdrew: Did not meet randomization criteria1100
Withdrew: Physician decision100
Withdrew: Withdrawal by subject800
Withdrew: Other100
Treatment Period (Up to 12 Weeks)
Participant flow — Treatment Period (Up to 12 Weeks)
MilestoneAll Enrolled ParticipantsSalbutamol HFA-152a MDISalbutamol HFA-134a MDI
Started0338112
Completed0326108
Not completed0124
Withdrew: Adverse event020
Withdrew: Lost to follow-up030
Withdrew: Physician decision010
Withdrew: Withdrawal by subject054
Withdrew: Other010

Outcome measures

PrimaryNumber of Participants With Adverse Events (AEs) During Run-in Period

An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

Time frame:
From Week -1 up to randomization (Day 1) during Run-in period
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs) During Run-in Period
ParticipantsAll Enrolled Participants
Number of Participants With Adverse Events (AEs) During Run-in Period0
PrimaryNumber of Participants With Adverse Events (AEs) During Treatment Period

An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

Time frame:
From randomization (Day 1) up to Week 13 (Follow up) during treatment period
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs) During Treatment Period
ParticipantsSalbutamol HFA-152a MDISalbutamol HFA-134a MDI
Number of Participants With Adverse Events (AEs) During Treatment Period10836
SecondaryNumber of Participants With Serious Adverse Events (SAEs) During Run-in Period

SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), Is a suspected transmission of any infectious agent via an authorized medicinal product, other situations judged by physician, is associated with liver injury and impaired liver function. SAEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

Time frame:
From Week -1 up to randomization (Day 1) during Run-in period
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events (SAEs) During Run-in Period
ParticipantsAll Enrolled Participants
Number of Participants With Serious Adverse Events (SAEs) During Run-in Period0
SecondaryNumber of Participants With Serious Adverse Events (SAEs) During Treatment Period

SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), Is a suspected transmission of any infectious agent via an authorized medicinal product, other situations judged by physician, is associated with liver injury and impaired liver function. SAEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

Time frame:
From randomization (Day 1) up to Week 13 (Follow up) during treatment period
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events (SAEs) During Treatment Period
ParticipantsSalbutamol HFA-152a MDISalbutamol HFA-134a MDI
Number of Participants With Serious Adverse Events (SAEs) During Treatment Period63
SecondaryAbsolute Values of Minimum Serum Potassium

Blood samples were collected to analyze minimum serum potassium.

Time frame:
Up to Week 13 (Follow up)
Reported as:
Mean · millimoles per liter (mmol/L)
Absolute Values of Minimum Serum Potassium
millimoles per liter (mmol/L)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Absolute Values of Minimum Serum Potassium3.985 ± 0.28654.025 ± 0.2993
SecondaryAbsolute Values of Serum Potassium at Each Assessed Visit

Blood samples were collected to analyze the serum potassium. Baseline value was defined as the pre-dose value on Day 1.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · millimoles per liter (mmol/L)
Absolute Values of Serum Potassium at Each Assessed Visit
millimoles per liter (mmol/L)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Baseline (Day 1, pre-dose)4.261 ± 0.36794.290 ± 0.4418
Week 14.284 ± 0.36644.296 ± 0.3888
Week 44.281 ± 0.41154.355 ± 0.5824
Week 84.285 ± 0.38204.386 ± 0.6236
Week 124.317 ± 0.44554.344 ± 0.4266
Week 134.309 ± 0.42374.402 ± 0.5819
SecondaryChange From Baseline (CFB) in Serum Potassium at Each Assessed Visit

Blood samples were collected to analyze the serum potassium. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · millimoles per liter (mmol/L)
Change From Baseline (CFB) in Serum Potassium at Each Assessed Visit
millimoles per liter (mmol/L)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
CFB to Week 10.019 ± 0.40920.004 ± 0.4337
Week 40.016 ± 0.40930.058 ± 0.5889
Week 80.014 ± 0.38010.079 ± 0.6324
Week 120.055 ± 0.47140.046 ± 0.4546
Week 130.033 ± 0.44500.084 ± 0.6125
SecondaryAbsolute Values of Hematology Parameter: Erythrocytes

Blood samples were collected to analyze the hematology parameter: Erythrocytes. Baseline value was defined as the pre-dose value on Day 1.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · Trillion cells per Liter (10^12 cells/L)
Absolute Values of Hematology Parameter: Erythrocytes
Trillion cells per Liter (10^12 cells/L)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Baseline (Day 1, pre-dose)4.67 ± 0.4334.66 ± 0.473
Week 14.58 ± 0.4364.54 ± 0.483
Week 44.62 ± 0.4474.61 ± 0.588
Week 84.60 ± 0.4404.56 ± 0.470
Week 124.65 ± 0.4374.65 ± 0.421
Week 134.61 ± 0.4164.55 ± 0.391
SecondaryChange From Baseline of Hematology Parameter: Erythrocytes

Blood samples were collected to analyze the hematology parameter: Erythrocytes. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · Trillion cells per Liter (10^12 cells/L)
Change From Baseline of Hematology Parameter: Erythrocytes
Trillion cells per Liter (10^12 cells/L)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Week 1-0.08 ± 0.313-0.11 ± 0.349
Week 4-0.06 ± 0.354-0.06 ± 0.527
Week 8-0.07 ± 0.355-0.09 ± 0.424
Week 12-0.02 ± 0.324-0.02 ± 0.314
Week 13-0.03 ± 0.377-0.10 ± 0.420
SecondaryAbsolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)

Blood samples were collected to analyze the hematology parameter: MCV. Baseline value was defined as the pre-dose value on Day 1.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · Femtoliter (fL)
Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
Femtoliter (fL)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Baseline (Day 1, pre-dose)91.2 ± 6.6792.0 ± 6.96
Week 191.7 ± 6.0992.8 ± 6.67
Week 491.7 ± 6.5992.7 ± 6.97
Week 892.2 ± 6.2992.6 ± 6.81
Week 1292.2 ± 6.3892.4 ± 6.36
Week 1391.6 ± 6.3692.0 ± 7.19
SecondaryChange From Baseline of Hematology Parameter: MCV

Blood samples were collected to analyze the hematology parameter: MCV. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · Femtoliter (fL)
Change From Baseline of Hematology Parameter: MCV
Femtoliter (fL)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Week 10.3 ± 3.920.8 ± 3.47
Week 40.6 ± 5.080.7 ± 4.73
Week 81.0 ± 4.270.7 ± 4.40
Week 120.9 ± 4.810.7 ± 3.82
Week 130.8 ± 4.840.4 ± 4.29
SecondaryAbsolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)

Blood samples were collected to analyze the hematology parameter: MCH. Baseline value was defined as the pre-dose value on Day 1.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · Picograms (pg)
Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Picograms (pg)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Baseline (Day 1, pre-dose)29.63 ± 2.45429.85 ± 2.426
Week 129.74 ± 2.38629.89 ± 2.419
Week 429.67 ± 2.40329.80 ± 2.609
Week 829.73 ± 2.29429.83 ± 2.499
Week 1229.75 ± 2.34129.67 ± 2.290
Week 1329.47 ± 2.33729.71 ± 2.844
SecondaryChange From Baseline of Hematology Parameter: MCH

Blood samples were collected to analyze the hematology parameter: MCH. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · Picograms (pg)
Change From Baseline of Hematology Parameter: MCH
Picograms (pg)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Week 10.04 ± 1.3060.09 ± 1.181
Week 40.05 ± 1.732-0.02 ± 1.857
Week 80.07 ± 1.4790.07 ± 1.724
Week 120.07 ± 1.571-0.03 ± 1.345
Week 13-0.02 ± 1.6560.03 ± 1.718
SecondaryAbsolute Values of Hematology Parameter: Percentage of Reticulocytes

Blood samples were collected to analyze the hematology parameter: Percentage of Reticulocytes. Baseline value was defined as the pre-dose value on Day 1.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · Percentage of reticulocytes in blood
Absolute Values of Hematology Parameter: Percentage of Reticulocytes
Percentage of reticulocytes in bloodSalbutamol HFA-152a MDISalbutamol HFA-134a MDI
Baseline (Day 1, pre-dose)0.0093 ± 0.016460.0087 ± 0.00358
Week 10.0087 ± 0.004390.0089 ± 0.00363
Week 40.0088 ± 0.004350.0094 ± 0.00419
Week 80.0084 ± 0.004320.0089 ± 0.00365
Week 120.0086 ± 0.004680.0085 ± 0.00422
Week 130.0084 ± 0.004740.0082 ± 0.00426
SecondaryChange From Baseline of Hematology Parameter: Percentage of Reticulocytes

Blood samples were collected to analyze the hematology parameter: Percentage of Reticulocytes. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · Percentage of reticulocytes in blood
Change From Baseline of Hematology Parameter: Percentage of Reticulocytes
Percentage of reticulocytes in bloodSalbutamol HFA-152a MDISalbutamol HFA-134a MDI
Week 1-0.0007 ± 0.016550.0002 ± 0.00347
Week 4-0.0006 ± 0.016530.0008 ± 0.00393
Week 8-0.0009 ± 0.016260.0003 ± 0.00335
Week 12-0.0008 ± 0.01686-0.0001 ± 0.00365
Week 13-0.0001 ± 0.003800.0001 ± 0.00431
SecondaryAbsolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets

Blood samples were collected to analyze the hematology parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and platelets. Baseline value was defined as the pre-dose value on Day 1.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · Giga cells per Liter (10^9 cells/L)
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Giga cells per Liter (10^9 cells/L)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Basophils, Baseline (Day 1, pre-dose)0.05359 ± 0.0288770.05152 ± 0.027971
Basophils, Week 10.05230 ± 0.0291340.04925 ± 0.029267
Basophils, Week 40.05067 ± 0.0268680.05168 ± 0.026439
Basophils, Week 80.05026 ± 0.0296460.04689 ± 0.030374
Basophils, Week 120.05027 ± 0.0274540.04786 ± 0.028822
Basophils, Week 130.04734 ± 0.0274330.04565 ± 0.031185
Eosinophils, Baseline (Day 1, pre-dose)0.25976 ± 0.2209180.27804 ± 0.255042
Eosinophils, Week 10.26076 ± 0.2170170.24736 ± 0.214797
Eosinophils, Week 40.24841 ± 0.2089480.27383 ± 0.241679
Eosinophils, Week 80.26923 ± 0.2311210.24849 ± 0.234256
Eosinophils, Week 120.27193 ± 0.2484520.23534 ± 0.199940
Eosinophils, Week 130.26438 ± 0.2366140.21806 ± 0.170850
Lymphocytes, Baseline (Day 1, pre-dose)2.00302 ± 0.6304292.03857 ± 0.589753
Lymphocytes, Week 11.90672 ± 0.6235071.89113 ± 0.622528
Lymphocytes, Week 41.92678 ± 0.6722821.92589 ± 0.589312
Lymphocytes, Week 81.94068 ± 0.6403581.93142 ± 0.580616
Lymphocytes, Week 121.90409 ± 0.5900981.92398 ± 0.530670
Lymphocytes, Week 131.87193 ± 0.5827941.84516 ± 0.588944
Monocytes, Baseline (Day 1, pre-dose)0.40180 ± 0.1791230.40366 ± 0.146195
Monocytes, Week 10.39618 ± 0.1662870.37604 ± 0.172702
Monocytes, Week 40.40172 ± 0.1842530.37355 ± 0.183129
Monocytes, Week 80.39548 ± 0.1877780.38613 ± 0.167960
Monocytes, Week 120.38853 ± 0.1694960.37039 ± 0.157654
Monocytes, Week 130.38594 ± 0.1864970.35403 ± 0.156838
Neutrophils, Baseline (Day 1, pre-dose)4.17512 ± 1.5929834.00464 ± 1.475535
Neutrophils, Week 14.28183 ± 1.7668114.14613 ± 1.658390
Neutrophils, Week 44.40694 ± 1.8321574.18075 ± 1.694496
Neutrophils, Week 84.38165 ± 1.7115464.06113 ± 1.574423
Neutrophils, Week 124.22314 ± 1.5594324.08505 ± 1.560278
Neutrophils, Week 134.17911 ± 1.5724084.03694 ± 1.542552
Platelets, Baseline (Day 1, pre-dose)278.0 ± 73.44273.4 ± 59.21
Platelets, Week 1276.3 ± 77.41267.7 ± 64.89
Platelets, Week 4282.4 ± 87.24272.3 ± 63.55
Platelets, Week 8282.2 ± 79.92270.1 ± 56.94
Platelets, Week 12277.7 ± 77.00271.4 ± 57.94
Platelets, Week 13280.4 ± 85.89273.5 ± 67.99
SecondaryChange From Baseline of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets

Blood samples were collected to analyze the hematology parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and platelets. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · Giga cells per Liter (10^9 cells/L)
Change From Baseline of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Giga cells per Liter (10^9 cells/L)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Basophils, Week 1-0.00057 ± 0.033195-0.00198 ± 0.034266
Basophils, Week 4-0.00235 ± 0.032068-0.00019 ± 0.033505
Basophils, Week 8-0.00302 ± 0.033942-0.00528 ± 0.032985
Basophils, Week 12-0.00378 ± 0.031841-0.00447 ± 0.028892
Basophils, Week 13-0.00644 ± 0.033980-0.00645 ± 0.036669
Eosinophils, Week 1-0.00029 ± 0.155357-0.02425 ± 0.170405
Eosinophils, Week 4-0.00923 ± 0.165629-0.00897 ± 0.171414
Eosinophils, Week 80.00672 ± 0.206049-0.02604 ± 0.183670
Eosinophils, Week 120.01083 ± 0.211799-0.04379 ± 0.188082
Eosinophils, Week 130.01377 ± 0.195234-0.05177 ± 0.176464
Lymphocytes, Week 1-0.09338 ± 0.540509-0.13792 ± 0.458240
Lymphocytes, Week 4-0.07421 ± 0.650006-0.11364 ± 0.480933
Lymphocytes, Week 8-0.07617 ± 0.583260-0.12283 ± 0.480680
Lymphocytes, Week 12-0.11180 ± 0.579879-0.09951 ± 0.491659
Lymphocytes, Week 13-0.15016 ± 0.651971-0.19016 ± 0.482964
Monocytes, Week 1-0.00704 ± 0.179329-0.02811 ± 0.144223
Monocytes, Week 40.00029 ± 0.187726-0.03037 ± 0.149047
Monocytes, Week 8-0.00971 ± 0.193656-0.01868 ± 0.156065
Monocytes, Week 12-0.01660 ± 0.167036-0.03767 ± 0.149202
Monocytes, Week 13-0.01555 ± 0.203099-0.06161 ± 0.145447
Neutrophils, Week 10.15803 ± 1.7706490.16972 ± 1.484200
Neutrophils, Week 40.25537 ± 1.8850830.13215 ± 1.388442
Neutrophils, Week 80.23750 ± 1.7780690.06047 ± 1.539975
Neutrophils, Week 120.10452 ± 1.7422050.03893 ± 1.585683
Neutrophils, Week 130.03147 ± 1.889040-0.00452 ± 1.802729
Platelets, Week 1-1.7 ± 54.08-6.8 ± 37.59
Platelets, Week 43.7 ± 66.30-1.2 ± 47.28
Platelets, Week 83.3 ± 55.61-3.2 ± 45.86
Platelets, Week 12-0.1 ± 58.11-2.3 ± 45.24
Platelets, Week 13-0.1 ± 62.501.3 ± 60.42
SecondaryAbsolute Values of Hematology Parameter: Hemoglobin (Hgb)

Blood samples were collected to analyze the hematology parameter: Hgb. Baseline value was defined as the pre-dose value on Day 1.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · gram per Liter (g/L)
Absolute Values of Hematology Parameter: Hemoglobin (Hgb)
gram per Liter (g/L)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Baseline (Day 1, pre-dose)137.8 ± 14.09138.3 ± 12.92
Week 1135.7 ± 14.22135.4 ± 13.90
Week 4136.6 ± 14.18136.5 ± 14.06
Week 8136.3 ± 13.58135.8 ± 13.08
Week 12137.9 ± 13.37137.7 ± 12.64
Week 13135.4 ± 13.89135.2 ± 13.08
SecondaryChange From Baseline of Hematology Parameter: Hemoglobin (Hgb)

Blood samples were collected to analyze the hematology parameter: Hgb. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · gram per Liter (g/L)
Change From Baseline of Hematology Parameter: Hemoglobin (Hgb)
gram per Liter (g/L)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Week 1-2.2 ± 8.67-2.7 ± 8.35
Week 4-1.5 ± 9.48-2.1 ± 8.95
Week 8-1.6 ± 10.27-2.4 ± 7.37
Week 12-0.3 ± 9.48-0.4 ± 7.82
Week 13-1.0 ± 10.11-2.3 ± 8.67
SecondaryAbsolute Values of Hematology Parameter: Hematocrit

Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline value was defined as the pre-dose value on Day 1.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · Percentage of red blood cells in blood
Absolute Values of Hematology Parameter: Hematocrit
Percentage of red blood cells in bloodSalbutamol HFA-152a MDISalbutamol HFA-134a MDI
Baseline (Day 1, pre-dose)0.4240 ± 0.039710.4261 ± 0.03703
Week 10.4182 ± 0.039440.4196 ± 0.04187
Week 40.4220 ± 0.040530.4239 ± 0.04257
Week 80.4229 ± 0.039400.4204 ± 0.04041
Week 120.4271 ± 0.039360.4275 ± 0.03777
Week 130.4207 ± 0.039300.4167 ± 0.03411
SecondaryChange From Baseline of Hematology Parameter: Hematocrit

Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · Percentage of red blood cells in blood
Change From Baseline of Hematology Parameter: Hematocrit
Percentage of red blood cells in bloodSalbutamol HFA-152a MDISalbutamol HFA-134a MDI
Week 1-0.0059 ± 0.02640-0.0058 ± 0.02880
Week 4-0.0027 ± 0.02738-0.0030 ± 0.03210
Week 8-0.0012 ± 0.03068-0.0050 ± 0.02623
Week 120.0021 ± 0.028810.0018 ± 0.02675
Week 130.0012 ± 0.02983-0.0068 ± 0.02796
SecondaryAbsolute Values of Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Urea and Glucose (Non-fasting)

Blood samples were collected to analyze the Clinical Chemistry parameters: Calcium, Potassium, Sodium, Urea and Glucose (non-fasting). Baseline value was defined as the pre-dose value on Day 1.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · millimoles per liter (mmol/L)
Absolute Values of Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Urea and Glucose (Non-fasting)
millimoles per liter (mmol/L)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Calcium, Baseline (Day 1, pre-dose)2.364 ± 0.09652.371 ± 0.0893
Calcium, Week 12.340 ± 0.09002.339 ± 0.0861
Calcium, Week 42.349 ± 0.10742.349 ± 0.0885
Calcium, Week 82.342 ± 0.09342.343 ± 0.0918
Calcium, Week 122.353 ± 0.09802.363 ± 0.0937
Calcium, Week 132.347 ± 0.09392.350 ± 0.1074
Potassium, Baseline (Day 1, pre-dose)4.261 ± 0.36794.290 ± 0.4418
Potassium, Week 14.284 ± 0.36644.296 ± 0.3888
Potassium, Week 44.281 ± 0.41154.355 ± 0.5824
Potassium, Week 84.285 ± 0.38204.386 ± 0.6236
Potassium, Week 124.317 ± 0.44554.344 ± 0.4266
Potassium, Week 134.309 ± 0.42374.402 ± 0.5819
Sodium, Baseline (Day 1, pre-dose)139.4 ± 1.99139.7 ± 2.24
Sodium, Week 1139.4 ± 2.18139.3 ± 2.24
Sodium, Week 4139.4 ± 2.04139.6 ± 2.02
Sodium, Week 8139.3 ± 2.35139.5 ± 2.26
Sodium, Week 12139.3 ± 2.10139.7 ± 2.26
Sodium, Week 13139.1 ± 2.41139.9 ± 2.17
Urea, Baseline (Day 1, pre-dose)5.128 ± 1.48934.925 ± 1.7168
Urea, Week 15.145 ± 1.56234.982 ± 1.7031
Urea, Week 45.281 ± 1.87745.216 ± 2.1149
Urea, Week 85.192 ± 1.66925.009 ± 1.7029
Urea, Week 125.160 ± 1.52445.060 ± 1.6184
Urea, Week 135.303 ± 1.71505.174 ± 1.7451
Glucose (non-fasting), Baseline (Day 1, pre-dose)5.31 ± 0.9655.23 ± 0.932
Glucose (non-fasting), Week 15.38 ± 1.4695.50 ± 1.647
Glucose (non-fasting), Week 45.55 ± 1.8475.31 ± 0.972
Glucose (non-fasting), Week 85.66 ± 2.0235.39 ± 1.339
Glucose (non-fasting), Week 125.40 ± 1.1735.33 ± 1.044
Glucose (non-fasting), Week 135.37 ± 1.5615.13 ± 0.636
SecondaryChange From Baseline of Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Urea and Glucose (Non-fasting)

Blood samples were collected to analyze the Clinical Chemistry parameters: Calcium, Potassium, Sodium, Urea and Glucose (non-fasting). Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · millimoles per Liter (mmol/L)
Change From Baseline of Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Urea and Glucose (Non-fasting)
millimoles per Liter (mmol/L)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Calcium, Week 1-0.024 ± 0.0914-0.031 ± 0.0851
Calcium, Week 4-0.016 ± 0.1029-0.022 ± 0.0965
Calcium, Week 8-0.022 ± 0.1015-0.026 ± 0.0855
Calcium, Week 12-0.012 ± 0.1009-0.006 ± 0.0933
Calcium, Week 13-0.015 ± 0.0995-0.014 ± 0.1077
Potassium, Week 10.019 ± 0.40920.004 ± 0.4337
Potassium, Week 40.016 ± 0.40930.058 ± 0.5889
Potassium, Week 80.014 ± 0.38010.079 ± 0.6324
Potassium, Week 120.055 ± 0.47140.046 ± 0.4546
Potassium, Week 130.033 ± 0.44500.084 ± 0.6125
Sodium, Week 10.0 ± 2.08-0.4 ± 2.09
Sodium, Week 40.0 ± 2.15-0.1 ± 1.94
Sodium, Week 8-0.1 ± 2.59-0.2 ± 2.38
Sodium, Week 12-0.1 ± 2.170.0 ± 2.29
Sodium, Week 13-0.3 ± 2.66-0.3 ± 2.45
Urea, Week 1-0.008 ± 1.40800.065 ± 1.2567
Urea, Week 40.118 ± 1.67610.273 ± 1.6778
Urea, Week 80.033 ± 1.33880.083 ± 1.6924
Urea, Week 120.014 ± 1.34590.166 ± 1.4426
Urea, Week 130.124 ± 1.58290.202 ± 1.5834
Glucose (non-fasting), Week 10.08 ± 1.4530.27 ± 1.359
Glucose (non-fasting), Week 40.24 ± 1.8230.09 ± 0.864
Glucose (non-fasting), Week 80.35 ± 1.9280.16 ± 0.945
Glucose (non-fasting), Week 120.09 ± 1.2450.10 ± 0.933
Glucose (non-fasting), Week 130.06 ± 1.4790.08 ± 0.754
SecondaryAbsolute Values of Clinical Chemistry Parameters: Direct Bilirubin Total Bilirubin and Creatinine

Blood samples were collected to analyze the Clinical Chemistry parameters: Direct Bilirubin Total Bilirubin and Creatinine. Baseline value was defined as the pre-dose value on Day 1.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · micromoles per Liter (umol/L)
Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin Total Bilirubin and Creatinine
micromoles per Liter (umol/L)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Direct Bilirubin, Baseline (Day 1, pre-dose)2.5 ± 1.332.4 ± 1.07
Direct Bilirubin, Week 12.5 ± 1.322.3 ± 1.07
Direct Bilirubin, Week 42.5 ± 1.332.3 ± 1.06
Direct Bilirubin, Week 82.5 ± 1.352.2 ± 1.08
Direct Bilirubin, Week 122.5 ± 1.872.4 ± 1.19
Direct Bilirubin, Week 132.5 ± 1.592.4 ± 1.10
Total Bilirubin, Baseline (Day 1, pre-dose)7.3 ± 4.636.4 ± 3.59
Total Bilirubin, Week 17.1 ± 4.286.0 ± 3.12
Total Bilirubin, Week 47.2 ± 4.396.5 ± 3.49
Total Bilirubin, Week 87.2 ± 4.656.0 ± 2.87
Total Bilirubin, Week 127.5 ± 5.226.8 ± 4.41
Total Bilirubin, Week 137.3 ± 5.196.7 ± 3.28
Creatinine, Baseline (Day 1, pre-dose)74.7 ± 16.9472.4 ± 16.64
Creatinine, Week 174.6 ± 17.2872.7 ± 16.43
Creatinine, Week 475.4 ± 18.3673.7 ± 16.57
Creatinine, Week 874.1 ± 17.0772.5 ± 14.84
Creatinine, Week 1274.9 ± 18.6773.7 ± 18.57
Creatinine, Week 1376.4 ± 18.8571.3 ± 14.54
SecondaryChange From Baseline of Clinical Chemistry Parameters: Direct Bilirubin Total Bilirubin and Creatinine

Blood samples were collected to analyze the Clinical Chemistry parameters: Direct Bilirubin Total Bilirubin and Creatinine. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · micromoles per Liter (umol/L)
Change From Baseline of Clinical Chemistry Parameters: Direct Bilirubin Total Bilirubin and Creatinine
micromoles per Liter (umol/L)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Direct Bilirubin, Week 10.1 ± 1.05-0.1 ± 1.08
Direct Bilirubin, Week 40.0 ± 1.27-0.1 ± 1.14
Direct Bilirubin, Week 80.0 ± 1.17-0.2 ± 1.32
Direct Bilirubin, Week 120.0 ± 1.770.1 ± 1.16
Direct Bilirubin, Week 130.0 ± 1.32-0.1 ± 1.16
Total Bilirubin, Week 1-0.2 ± 3.79-0.4 ± 3.12
Total Bilirubin, Week 4-0.1 ± 4.380.1 ± 3.76
Total Bilirubin, Week 8-0.1 ± 4.34-0.4 ± 3.24
Total Bilirubin, Week 120.1 ± 4.550.4 ± 3.90
Total Bilirubin, Week 130.2 ± 4.310.0 ± 3.49
Creatinine, Week 1-0.3 ± 12.870.4 ± 10.66
Creatinine, Week 40.5 ± 13.671.2 ± 12.68
Creatinine, Week 8-0.9 ± 12.000.1 ± 10.50
Creatinine, Week 12-0.2 ± 14.251.3 ± 12.70
Creatinine, Week 130.4 ± 15.94-1.4 ± 10.52
SecondaryAbsolute Values of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)

Blood samples were collected to analyze the Clinical Chemistry Parameters: ALP, ALT, AST and CPK. Baseline value was defined as the pre-dose value on Day 1.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · International Units per Liter (IU/L)
Absolute Values of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
International Units per Liter (IU/L)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
ALP, Baseline (Day 1, pre-dose)75.3 ± 22.0378.2 ± 25.28
ALP, Week 175.5 ± 21.8077.6 ± 24.96
ALP, Week 477.6 ± 24.4379.6 ± 24.51
ALP, Week 877.7 ± 32.8877.9 ± 25.06
ALP, Week 1277.2 ± 22.4378.9 ± 25.54
ALP, Week 1377.5 ± 29.0677.3 ± 27.52
ALT, Baseline (Day 1, pre-dose)19.9 ± 10.5619.8 ± 9.01
ALT, Week 121.1 ± 15.0021.0 ± 11.16
ALT, Week 421.1 ± 13.5924.3 ± 25.57
ALT, Week 820.1 ± 13.7920.4 ± 10.74
ALT, Week 1221.1 ± 17.3219.8 ± 8.85
ALT, Week 1319.4 ± 10.7219.8 ± 9.27
AST, Baseline (Day 1, pre-dose)19.9 ± 7.3021.2 ± 7.40
AST, Week 120.6 ± 11.9821.4 ± 9.36
AST, Week 420.5 ± 8.8323.2 ± 13.73
AST, Week 819.5 ± 6.5522.4 ± 12.50
AST, Week 1220.7 ± 10.4921.0 ± 7.23
AST, Week 1319.0 ± 6.2820.8 ± 7.73
CPK, Baseline (Day 1, pre-dose)130.5 ± 111.95148.0 ± 116.23
CPK, Week 1183.2 ± 564.40141.2 ± 104.62
CPK, Week 4151.6 ± 250.70167.6 ± 176.75
CPK, Week 8133.8 ± 126.62218.7 ± 506.04
CPK, Week 12136.2 ± 133.57147.6 ± 165.58
CPK, Week 13129.3 ± 112.59128.7 ± 83.21
SecondaryChange From Baseline of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)

Blood samples were collected to analyze the Clinical Chemistry Parameters: ALP, ALT, AST and CPK. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · International Units per Liter (IU/L)
Change From Baseline of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
International Units per Liter (IU/L)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
ALP, Week 10.1 ± 11.55-0.7 ± 12.16
ALP, Week 42.3 ± 17.061.2 ± 14.15
ALP, Week 82.1 ± 28.89-0.6 ± 11.75
ALP, Week 121.9 ± 13.820.4 ± 13.55
ALP, Week 133.1 ± 24.13-1.2 ± 19.25
ALT, Week 11.1 ± 12.711.2 ± 6.53
ALT, Week 41.0 ± 11.254.3 ± 22.37
ALT, Week 80.0 ± 10.860.6 ± 8.39
ALT, Week 121.2 ± 15.430.1 ± 8.39
ALT, Week 13-0.4 ± 9.51-0.2 ± 10.44
AST, Week 10.7 ± 10.850.2 ± 5.72
AST, Week 40.6 ± 7.832.0 ± 12.79
AST, Week 8-0.5 ± 5.731.1 ± 10.74
AST, Week 120.8 ± 10.57-0.1 ± 6.19
AST, Week 13-0.9 ± 6.24-1.3 ± 7.83
CPK, Week 152.0 ± 555.63-8.0 ± 104.14
CPK, Week 420.9 ± 253.2618.0 ± 186.25
CPK, Week 83.1 ± 109.8970.5 ± 486.88
CPK, Week 125.3 ± 113.13-0.3 ± 168.23
CPK, Week 13-4.2 ± 111.73-26.3 ± 112.91
SecondaryAbsolute Value of Urinalysis Parameter: Potential of Hydrogen (pH)

Urine samples were collected to analyze the pH. Baseline value was defined as the pre-dose value on Day 1.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · Potential of Hydrogen (pH)
Absolute Value of Urinalysis Parameter: Potential of Hydrogen (pH)
Potential of Hydrogen (pH)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Baseline (Day 1, pre-dose)6.06 ± 0.7865.95 ± 0.761
Week 16.00 ± 0.7355.89 ± 0.727
Week 46.01 ± 0.7815.95 ± 0.799
Week 86.03 ± 0.7356.04 ± 0.689
Week 126.01 ± 0.7645.97 ± 0.752
Week 136.00 ± 0.7736.06 ± 0.689
SecondaryChange From Baseline of Urinalysis Parameter: Potential of Hydrogen (pH)

Urine samples were collected to analyze the pH. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · Potential of Hydrogen (pH)
Change From Baseline of Urinalysis Parameter: Potential of Hydrogen (pH)
Potential of Hydrogen (pH)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Week 1-0.06 ± 0.832-0.06 ± 0.904
Week 4-0.05 ± 0.8250.00 ± 0.804
Week 8-0.03 ± 0.8050.08 ± 0.782
Week 12-0.06 ± 0.8130.00 ± 0.824
Week 13-0.04 ± 0.8420.06 ± 0.969
SecondaryAbsolute Value of Urinalysis Parameter: Specific Gravity

Urine samples were collected to analyze the Specific Gravity. Baseline value was defined as the pre-dose value on Day 1.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · Ratio
Absolute Value of Urinalysis Parameter: Specific Gravity
RatioSalbutamol HFA-152a MDISalbutamol HFA-134a MDI
Baseline (Day 1, pre-dose)1.0173 ± 0.016461.0156 ± 0.00932
Week 11.0159 ± 0.008891.0165 ± 0.01003
Week 41.0160 ± 0.008611.0106 ± 0.04960
Week 81.0161 ± 0.008131.0153 ± 0.00866
Week 121.0160 ± 0.008111.0168 ± 0.01469
Week 131.0164 ± 0.008571.0164 ± 0.01308
SecondaryChange From Baseline of Urinalysis Parameter: Specific Gravity

Urine samples were collected to analyze the Specific Gravity. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · Ratio
Change From Baseline of Urinalysis Parameter: Specific Gravity
RatioSalbutamol HFA-152a MDISalbutamol HFA-134a MDI
Week 1-0.0015 ± 0.015800.0008 ± 0.01057
Week 4-0.0015 ± 0.01665-0.0051 ± 0.04913
Week 8-0.0014 ± 0.01656-0.0002 ± 0.00992
Week 12-0.0015 ± 0.016480.0013 ± 0.01653
Week 13-0.0005 ± 0.010590.0007 ± 0.01318
SecondaryNumber 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

Urinalysis parameters were assessed using standard Urinalysis dipsticks and categorized according to the semi-quantitative scale provided by the test strip manufacturer (e.g.,negative, trace, 1+,2+,3+,where applicable). For each parameter, worsening from baseline was defined as a shift from a lower category (Increased to TRACE \& Non-hemolyzed TRACE), to a higher category (Increased to 1+, 2+, 3+, 4+, or 1, 2,4, 8 mg/dL \& hemolyzed TRACE), indicating a greater degree of abnormality. The worst post-baseline category observed during the study was compared with the baseline category to derive a worst-case post-baseline change classification. Participants were categorized according to the magnitude of worsening observed (e.g.,No Change/Decreased, Increase to TRACE, Increase to 1+, Increase to 2+, etc., as applicable for the parameter assessed). Values that trend towards 'normal' or a lower category (i.e. from 2+ to 1+) indicates a shift towards /return to a negative result.

Time frame:
Up to Week 13 (Follow up)
Reported as:
Count of participants · Participants
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
ParticipantsSalbutamol HFA-152a MDISalbutamol HFA-134a MDI
Occult Blood, No Change/Decreased27990
Occult Blood, Increase to NON-HEMOLYZED TRACE156
Occult Blood, Increase to NON-HEMOLYZED MODERATE00
Occult Blood, Increase to HEMOLYZED TRACE31
Occult Blood, Increase to 1+74
Occult Blood, Increase to 2+144
Occult Blood, Increase to 3+177
Protein, No Change/Decreased27693
Protein, Increase to TRACE3811
Protein, Increase to 1+165
Protein, Increase to 2+31
Protein, Increase to 3+12
Protein, Increase to 4+10
Urobilinogen, No Change/Decreased321102
Urobilinogen, Increase to 1 mg/dL149
Urobilinogen, Increase to 2 mg/dL00
Urobilinogen, Increase to 4 mg/dL01
Urobilinogen, Increase to 8 mg/dL00
Bilirubin, No Change/Decreased314105
Bilirubin, Increase to 1+156
Bilirubin, Increase to 2+41
Bilirubin, Increase to 3+20
Glucose, No Change/Decreased330110
Glucose, Increase to TRACE20
Glucose, Increase to 1+00
Glucose, Increase to 2+10
Glucose, Increase to 3+01
Glucose, Increase to 4+21
Ketones, No Change/Decreased313105
Ketones, Increase to TRACE124
Ketones, Increase to 1+51
Ketones, Increase to 2+32
Ketones, Increase to 3+10
Ketones, Increase to 4+10
Leukocyte Estererase, No Change/Decreased30793
Leukocyte Estererase, Increase to TRACE52
Leukocyte Estererase, Increase to 1+97
Leukocyte Estererase, Increase to 2+106
Leukocyte Estererase, Increase to 3+44
Leukocyte Estererase, Increase to 4+00
Nitrite, No Change/Decreased331111
Nitrite, Increase to POSITIVE41
SecondaryAbsolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

SDP and DBP measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Baseline value was defined as the pre-dose value on Day 1.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · millimeters of mercury (mm Hg)
Absolute Values for Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
millimeters of mercury (mm Hg)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Systolic Blood Pressure, Baseline (Day 1, pre-dose)122.0 ± 12.93121.0 ± 11.73
Systolic Blood Pressure, Week 1122.8 ± 12.72120.1 ± 11.49
Systolic Blood Pressure, Week 4121.8 ± 12.27120.8 ± 10.54
Systolic Blood Pressure, Week 8121.8 ± 12.29121.2 ± 10.89
Systolic Blood Pressure, Week 12121.6 ± 12.96121.4 ± 12.24
Systolic Blood Pressure, Week 13121.0 ± 11.87120.5 ± 10.77
Diastolic Blood Pressure, Baseline (Day 1, pre-dose)74.9 ± 9.2375.4 ± 8.53
Diastolic Blood Pressure, Week 175.3 ± 8.4874.4 ± 7.78
Diastolic Blood Pressure, Week 475.0 ± 8.5075.2 ± 8.03
Diastolic Blood Pressure, Week 875.3 ± 8.1875.1 ± 8.60
Diastolic Blood Pressure, Week 1275.6 ± 8.0975.0 ± 7.98
Diastolic Blood Pressure, Week 1374.6 ± 7.7275.0 ± 7.53
SecondaryChange From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

SBP and DBP measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · millimeters of mercury (mm Hg)
Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
millimeters of mercury (mm Hg)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Systolic Blood Pressure, Week 10.9 ± 9.11-0.8 ± 9.95
Systolic Blood Pressure, Week 40.0 ± 9.89-0.2 ± 10.99
Systolic Blood Pressure, Week 80.0 ± 10.360.2 ± 11.80
Systolic Blood Pressure, Week 12-0.3 ± 11.110.1 ± 11.06
Systolic Blood Pressure, Week 13-0.8 ± 10.24-0.5 ± 10.32
Diastolic Blood Pressure, Week 10.5 ± 7.72-1.0 ± 7.88
Diastolic Blood Pressure, Week 40.3 ± 8.06-0.2 ± 7.52
Diastolic Blood Pressure, Week 80.6 ± 8.77-0.3 ± 8.32
Diastolic Blood Pressure, Week 120.9 ± 8.82-0.4 ± 7.77
Diastolic Blood Pressure, Week 130.7 ± 9.270.3 ± 7.39
SecondaryAbsolute Values for Vital Signs: Pulse Rate

Pulse rate measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Baseline value was defined as the pre-dose value on Day 1.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · beats per minute
Absolute Values for Vital Signs: Pulse Rate
beats per minuteSalbutamol HFA-152a MDISalbutamol HFA-134a MDI
Baseline (Day 1, pre-dose)71.9 ± 10.7172.3 ± 10.82
Week 172.5 ± 10.2871.9 ± 9.94
Week 471.7 ± 9.6870.4 ± 10.10
Week 872.8 ± 9.7271.9 ± 11.58
Week 1272.2 ± 10.2071.0 ± 10.39
Week 1372.3 ± 9.8670.3 ± 9.46
SecondaryChange From Baseline in Vital Signs: Pulse Rate

Pulse rate measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · beats per minute
Change From Baseline in Vital Signs: Pulse Rate
beats per minuteSalbutamol HFA-152a MDISalbutamol HFA-134a MDI
Week 10.5 ± 8.59-0.4 ± 8.82
Week 4-0.1 ± 8.94-1.9 ± 9.16
Week 80.9 ± 10.46-0.4 ± 9.04
Week 120.3 ± 9.88-1.4 ± 9.52
Week 13-0.7 ± 10.51-1.9 ± 7.95
SecondaryAbsolute Values for 12 Lead Electrocardiograms (ECGs) in QT Interval Corrected by Fridericia's Formula (QTcF)

A standard 12-lead ECG was obtained using an ECG machine that automatically measures QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures were averaged for QTc interval to derive one Baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline was defined as the mean of the triplicate 12-lead ECG measurement from the Day 1 assessment (pre-dose).

Time frame:
Baseline (Day 1, mean of the pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · milliseconds (ms)
Absolute Values for 12 Lead Electrocardiograms (ECGs) in QT Interval Corrected by Fridericia's Formula (QTcF)
milliseconds (ms)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Baseline (Day 1, pre-dose)400.3 ± 16.70402.3 ± 20.52
Week 1401.3 ± 17.82402.2 ± 20.10
Week 4401.1 ± 18.57404.2 ± 19.97
Week 8400.4 ± 18.75404.5 ± 21.66
Week 12401.1 ± 18.04404.0 ± 19.02
Week 13398.6 ± 17.72400.1 ± 19.37
SecondaryChange From Baseline for 12 Lead ECGs in QTcF

A standard 12-lead ECG was obtained using an ECG machine that automatically measures QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures were averaged for QTc interval to derive one Baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline was defined as the mean of the triplicate 12-lead ECG measurement from the Day 1 assessment (pre-dose). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, mean of the pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · milliseconds (ms)
Change From Baseline for 12 Lead ECGs in QTcF
milliseconds (ms)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Week 11.1 ± 13.280.0 ± 15.53
Week 40.8 ± 13.612.2 ± 14.24
Week 80.2 ± 14.782.4 ± 15.55
Week 121.2 ± 13.481.7 ± 16.88
Week 13-0.7 ± 13.450.5 ± 14.50
SecondaryAbsolute Values for Heart Rate

A standard 12-lead ECG was obtained using an ECG machine that automatically measures HR. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures were averaged for HR to derive one Baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline was defined as the mean of the triplicate 12-lead ECG measurement from the Day 1 assessment (pre-dose).

Time frame:
Baseline (Day 1, mean of the pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · beats per minute
Absolute Values for Heart Rate
beats per minuteSalbutamol HFA-152a MDISalbutamol HFA-134a MDI
Baseline (Day 1, pre-dose)70.5 ± 11.8069.5 ± 11.57
Week 171.8 ± 11.9769.9 ± 11.34
Week 471.7 ± 12.1968.4 ± 11.25
Week 872.2 ± 11.4469.4 ± 11.16
Week 1270.7 ± 11.1170.1 ± 12.00
Week 1371.8 ± 11.3268.1 ± 10.80
SecondaryChange From Baseline in Heart Rate

A standard 12-lead ECG was obtained using an ECG machine that automatically measures HR. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures were averaged for HR to derive one Baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline was defined as the mean of the triplicate 12-lead ECG measurement from the Day 1 assessment (pre-dose). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, mean of the pre-dose), Weeks 1, 4, 8, 12 and 13
Reported as:
Mean · beats per minute
Change From Baseline in Heart Rate
beats per minuteSalbutamol HFA-152a MDISalbutamol HFA-134a MDI
Week 11.2 ± 8.970.4 ± 8.25
Week 41.0 ± 9.66-1.1 ± 7.78
Week 81.5 ± 10.050.1 ± 7.88
Week 120.0 ± 10.420.8 ± 9.42
Week 13-0.3 ± 9.85-1.8 ± 7.97
SecondaryChange From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score

The ACQ-6 measures 6 attributes of asthma control and are measured with a participant completed questionnaire. ACQ-6 consists of six questionnaires about the frequency and/or severity of symptoms (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath, wheeze and rescue medication use). Each question was scored from zero (no impairment/limitation) to six (total impairment/ limitation). The ACQ-6 score is calculated as the mean of the scores from the six questionnaire items. ACQ-6 score ranges from 0 to 6 with higher scores indicate greater impairment. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, pre-dose) and Week 12
Reported as:
Mean · Scores on a scale
Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score
Scores on a scaleSalbutamol HFA-152a MDISalbutamol HFA-134a MDI
Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score0.083 ± 0.53120.003 ± 0.4952
SecondaryChange From Baseline for Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

Forced Expiratory Volume in one second (FEV1) is defined as the volume of air forcibly exhaled in one second. Pre-bronchodilator FEV1 measurements were taken by spirometry. Baseline value was defined as the pre-dose value on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.

Time frame:
Baseline (Day 1, pre-dose) and Week 12
Reported as:
Mean · Liter (L)
Change From Baseline for Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Liter (L)Salbutamol HFA-152a MDISalbutamol HFA-134a MDI
Change From Baseline for Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)0.017 ± 0.34220.056 ± 0.3257

Adverse events

Collected over All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from Week -1 up to randomization (Day 1) during Run-in period and from randomization (Day 1) up to Week 13 (Follow up) during treatment period.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Salbutamol HFA-134a MDI (Run-in Period)0/471 (0%)0/471 (0%)0/471 (0%)
Salbutamol HFA-152a MDI (Treatment Period)0/338 (0%)6/338 (1.8%)38/338 (11.2%)
Salbutamol HFA-134a MDI (Treatment Period)0/112 (0%)3/112 (2.7%)14/112 (12.5%)
Most frequent serious events
Most frequent serious events
EventSalbutamol HFA-134a MDI (Run-in Period)Salbutamol HFA-152a MDI (Treatment Period)Salbutamol HFA-134a MDI (Treatment Period)
Umbilical herniaGastrointestinal disorders0/4710/3381/112
Viral infectionInfections and infestations0/4710/3381/112
Alanine aminotransferase increasedInvestigations0/4710/3381/112
Drug-induced liver injuryHepatobiliary disorders0/4711/3380/112
CellulitisInfections and infestations0/4711/3380/112
Lower limb fractureInjury, poisoning and procedural complications0/4711/3380/112
Shoulder fractureInjury, poisoning and procedural complications0/4711/3380/112
BursitisMusculoskeletal and connective tissue disorders0/4711/3380/112
MigraineNervous system disorders0/4711/3380/112
AsthmaRespiratory, thoracic and mediastinal disorders0/4711/3380/112
Most frequent other events
Most frequent other events
EventSalbutamol HFA-134a MDI (Run-in Period)Salbutamol HFA-152a MDI (Treatment Period)Salbutamol HFA-134a MDI (Treatment Period)
Upper respiratory tract infectionInfections and infestations0/47116/3385/112
NasopharyngitisInfections and infestations0/47110/3384/112
Urinary tract infectionInfections and infestations0/4717/3384/112
AsthmaRespiratory, thoracic and mediastinal disorders0/47112/3383/112

Baseline characteristics

Enrolled Population included all participants who passed screening and entered the study.

Age, Continuous
Age, Continuous(YEARS)All Enrolled Participants
Mean47.2 ± 14.97
Sex: Female, Male
Sex: Female, Male(Participants)All Enrolled Participants
Female304
Male167
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)All Enrolled Participants
American Indian or Alaska Native5
Asian38
Black or African American40
Native Hawaiian or Other Pacific Islander1
White362
Multiple10
Not reported2
Unknown13
08

Study locations

102 sites
  • GSK Investigational Site
    North Hollywood, California 91606-3287, United States
  • GSK Investigational Site
    San Mateo, California 94403, United States
  • GSK Investigational Site
    Aventura, Florida 33180, United States
  • GSK Investigational Site
    Clearwater, Florida 33756, United States
  • GSK Investigational Site
    DeLand, Florida 32720, United States
  • GSK Investigational Site
    Miami, Florida 33144, United States
  • GSK Investigational Site
    Miami, Florida 33155, United States
  • GSK Investigational Site
    Miami, Florida 33173, United States
  • GSK Investigational Site
    Naples, Florida 34102, United States
  • GSK Investigational Site
    Plantation, Florida 33317, United States
  • GSK Investigational Site
    Winter Park, Florida 32789-3385, United States
  • GSK Investigational Site
    Rincon, Georgia 31326-5131, United States
  • GSK Investigational Site
    Stonecrest, Georgia 30038, United States
  • GSK Investigational Site
    Louisville, Kentucky 40217, United States
  • GSK Investigational Site
    Owensboro, Kentucky 42301, United States
  • GSK Investigational Site
    Fall River, Massachusetts 02723-1511, United States
  • GSK Investigational Site
    Minneapolis, Minnesota 55402-2508, United States
  • GSK Investigational Site
    Minneota, Minnesota 56001, United States
  • GSK Investigational Site
    Olive Branch, Mississippi 38654, United States
  • GSK Investigational Site
    Columbia, Missouri 65203, United States
  • GSK Investigational Site
    Henderson, Nevada 89052-5015, United States
  • GSK Investigational Site
    Jersey City, New Jersey 07306, United States
  • GSK Investigational Site
    Riverdale, New Jersey 07457, United States
  • GSK Investigational Site
    Brooklyn, New York 11220, United States
  • GSK Investigational Site
    Asheville, North Carolina 28803, United States
  • GSK Investigational Site
    Winston-Salem, North Carolina 27104, United States
  • GSK Investigational Site
    Cincinnati, Ohio 45231, United States
  • GSK Investigational Site
    Dublin, Ohio 43016, United States
  • GSK Investigational Site
    Medford, Oregon 97504, United States
  • GSK Investigational Site
    Philadelphia, Pennsylvania 19107, United States
  • GSK Investigational Site
    Pittsburgh, Pennsylvania 15241, United States
  • GSK Investigational Site
    Pottstown, Pennsylvania 19464-3241, United States
  • GSK Investigational Site
    Rock Hill, South Carolina 29732, United States
  • GSK Investigational Site
    Spartanburg, South Carolina 29303-4225, United States
  • GSK Investigational Site
    Spartanburg, South Carolina 29303, United States
  • GSK Investigational Site
    Union, South Carolina 29379-7409, United States
  • GSK Investigational Site
    Sugar Land, Texas 77479, United States
  • GSK Investigational Site
    Tomball, Texas 77375-3332, United States
  • GSK Investigational Site
    Buenos Aires, C1425AZE, Argentina
  • GSK Investigational Site
    Buenos Aires, C1425BEN, Argentina
  • GSK Investigational Site
    Buenos Aires, C1426ABP, Argentina
  • GSK Investigational Site
    La Plata, 1900, Argentina
  • GSK Investigational Site
    Mendoza, M5500CCG, Argentina
  • GSK Investigational Site
    Botany, New South Wales 2019, Australia
  • GSK Investigational Site
    Coffs Harbour, New South Wales 2450, Australia
  • GSK Investigational Site
    Kanwal, New South Wales 2259, Australia
  • GSK Investigational Site
    Spearwood, Western Australia 6163, Australia
  • GSK Investigational Site
    Ajax, Ontario L1S 2J5, Canada
  • GSK Investigational Site
    Brampton, Ontario L6T 0G1, Canada
  • GSK Investigational Site
    Ottawa, Ontario K1H 1E4, Canada
  • GSK Investigational Site
    Toronto, Ontario M9V 4B4, Canada
  • GSK Investigational Site
    Windsor, Ontario N8X 2G1, Canada
  • GSK Investigational Site
    Québec, Quebec G1V 4W2, Canada
  • GSK Investigational Site
    Québec, Quebec G1W 4R4, Canada
  • GSK Investigational Site
    Amiens, 80054, France
  • GSK Investigational Site
    Argenteuil, 95100, France
  • GSK Investigational Site
    Créteil, 94010, France
  • GSK Investigational Site
    Poitiers, 86021, France
  • GSK Investigational Site
    Pontoise, 95303, France
  • GSK Investigational Site
    Strasbourg, 67091, France
  • GSK Investigational Site
    Athens, 15669, Greece
  • GSK Investigational Site
    Larissa, 41110, Greece
  • GSK Investigational Site
    Thessaloniki, 57010, Greece
  • GSK Investigational Site
    Roma, RM 00161, Italy
  • GSK Investigational Site
    Cagliari, 09042, Italy
  • GSK Investigational Site
    Florence, 50134, Italy
  • GSK Investigational Site
    Foggia, 71100, Italy
  • GSK Investigational Site
    Milan, 20162, Italy
  • GSK Investigational Site
    Naples, 80131, Italy
  • GSK Investigational Site
    Padova, 35128, Italy
  • GSK Investigational Site
    Torino, 10128, Italy
  • GSK Investigational Site
    Tradate VA, 21100, Italy
  • GSK Investigational Site
    Verona, 37134, Italy
  • GSK Investigational Site
    Panama City, 7002, Panama
  • GSK Investigational Site
    Panama City, 7099, Panama
  • GSK Investigational Site
    Panama City, Panama
  • GSK Investigational Site
    Iloilo City, 5000, Philippines
  • GSK Investigational Site
    Bialystok, 15-010, Poland
  • GSK Investigational Site
    Bielsko-Biala, 43-300, Poland
  • GSK Investigational Site
    Chorzów, 41-500, Poland
  • GSK Investigational Site
    Elblag, 82-300, Poland
  • GSK Investigational Site
    Katowice, 40-600, Poland
  • GSK Investigational Site
    Ostrowiec Świętokrzyski, 27-400, Poland
  • GSK Investigational Site
    Płock, 09-407, Poland
  • GSK Investigational Site
    Tarnów, 33-100, Poland
  • GSK Investigational Site
    Barcelona, 08017, Spain
  • GSK Investigational Site
    Barcelona, 08540, Spain
  • GSK Investigational Site
    Benalmádena, 29631, Spain
  • GSK Investigational Site
    Madrid, 28031, Spain
  • GSK Investigational Site
    Madrid, 28040, Spain
  • GSK Investigational Site
    Madrid, 28041, Spain
  • GSK Investigational Site
    Marbella, 29603, Spain
  • GSK Investigational Site
    Pozuelo de AlarcOn Madr, 28223, Spain
  • GSK Investigational Site
    Pathum Thani, 12120, Thailand
  • GSK Investigational Site
    Bebington, CH63 9JP, United Kingdom
  • GSK Investigational Site
    Cambridgeshire, CB7 5JD, United Kingdom
  • GSK Investigational Site
    Corby, NN17 2UR, United Kingdom
  • GSK Investigational Site
    Greater Manchester, OL6 6HD, United Kingdom
  • GSK Investigational Site
    Guisborough, TS14 7DJ, United Kingdom
  • GSK Investigational Site
    Hounslow, TW3 3EL, United Kingdom

Showing the first 100 of 102 sites across 13 countries.

09

References and documents

Study documents

  • Study protocol · Nov 28, 2024
  • Statistical analysis plan · Aug 28, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

1 registry update since Sep 25, 2026
Results
Results posted
posted Oct 6, 2026
Sites
2 sites added, 1 site removed
Show 2 added (1 United States, 1 Italy)
  • GSK Investigational Site · Spartanburg, United States
  • GSK Investigational Site · Roma, Italy
Show 1 removed
  • GSK Investigational Site · Roma, Italy
Oct 6, 2026
Enrollment
477→471
Oct 6, 2026
Also revised
primary outcomes and interventions
Show all 1 update
  1. Oct 6, 2026
    Results posted
    2 sites added, 1 site removed
    Show 2 added (1 United States, 1 Italy)
    • GSK Investigational Site · Spartanburg, United States
    • GSK Investigational Site · Roma, Italy
    Show 1 removed
    • GSK Investigational Site · Roma, Italy
    Enrollment 477→471
    Primary outcomes Revised (3 changes)
    Interventions Arms or interventions changed
    + 6 other changes: identifiers, verification date, secondary outcomes, data sharing statement, index terms and documents

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT06261957
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Feb 15, 2024
Start date
May 31, 2024
Primary completion
Sep 2, 2025
Completion
Sep 2, 2025
Results posted
Oct 6, 2026
Last update
Oct 6, 2026

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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