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CompletedNCT06433908Updated Jan 12, 2026Results posted

A Study to Compare the Pharmacokinetics (PK) of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152A (Test) or HFA-134A (Reference) in Healthy Participants Aged 18 to 55 Inclusive

A Phase 1 interventional study of Salbutamol HFA-152a and Salbutamol HFA-134a in Asthma and Healthy Participants, sponsored by GlaxoSmithKline. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-12.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The primary objective of the study is to characterize the PK of single doses of salbutamol in healthy participants delivered via an MDI containing propellant HFA-152a (test), and to compare with an MDI containing propellant HFA-134a (reference).

02

Conditions studied

  • Asthma
  • Healthy Participants

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Keywords

  • salbutamol
  • propellant HFA-152a
  • propellant HFA-134a
  • metered dose inhalers
  • healthy participants
  • asthma
03

In context

Asthma

3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 60 is below the median of 83 across 2,751 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 to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Sex: male or female; females may be of childbearing potential, of nonchild bearing potential, or postmenopausal.
  2. Age: 18 to 55 years inclusive.
  3. Weight: 45 to 110 kg inclusive
  4. Status: healthy participants.
  5. Females must not be pregnant or lactating.
  6. All prescribed medication must have been stopped at least 30 days prior to admission to the clinical research center based on investigator judgment. An exception is made for hormonal contraceptives, which may be used throughout the study.
  7. All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) must have been stopped at least 14 days prior to admission to the clinical research center based on investigator judgment. An exception is made for acetaminophen, which is allowed up to admission to the clinical research center.
  8. Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to screening, and from 48 hours (2 days) prior to admission until discharge from the clinical research center.
  9. Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) prior to admission until discharge from the clinical research center.
  10. Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the investigator.
  11. Serum potassium and serum glucose levels within reference ranges of the clinical research center.
  12. Willing and able to sign the informed consent form.
  13. Spirometry at screening demonstrating forced expiratory volume ≥80% predicted.

Exclusion criteria

Exclusion Criteria:

  1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
  2. History or presence of any form of asthma, including childhood asthma and exercise induced asthma.
  3. At screening, systolic blood pressure \<90 mmHg or >140 mmHg, or diastolic blood pressure \<50 mmHg or >90 mmHg.
  4. History of pathological tachycardia, or a pulse rate > 85 beats per minute (bpm) at screening or Day-1.
  5. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
  6. Breast cancer within the past 10 years.
  7. A QTcF value of >450 msec at screening based on a triplicate measurement taken at a single timepoint.
  8. Vaccine(s) within 2 weeks prior to admission, or plans to receive such vaccines during the study.
  9. Donation or loss of more than 450 mL of blood within 60 days prior to (the first) drug administration. Donation or loss of more than 1.5 L of blood (for male participants) or more than 1.0 L of blood (for female participants) in the 10 months prior to (the first) drug administration in the current study.
  10. Participation in a drug study within 30 days prior to (the first) drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to (the first) drug administration in the current study.
  11. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  12. Presence of hepatitis B surface antigen at screening or within 3 months prior to first dose of study intervention.
  13. Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. NOTE: Participants with positive hepatitis C antibody test result due to prior resolved disease can be enrolled if a confirmatory negative hepatitis C RNA test is obtained.
  14. Positive pre-study drug/alcohol screen, including tetrahydrocannabinol.
  15. Positive HIV antibody test.

  16. Cotinine levels indicative of smoking or history or use of tobacco- or nicotine containing products within 6 months prior to screening.

    Assessment as ineligible by the investigator based on the results of the clinical laboratory tests or other assessments.

  17. Average intake of more than 24 units of alcohol per week: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits.
  18. Regular use of known drugs of abuse, including tetrahydrocannabinol.
  19. Use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to "vape" within 6 months prior to screening.
  20. Use of any products intended to treat medical conditions that are not approved by the governing health authority in a given country or region (for example, herbal medicine, health supplements, traditional medicine, homeopathic remedies, etc.).
  21. Impairment which would prevent the correct and consistent use of an MDI, as determined by the investigator/delegate.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Cohort 1: Salbutamol 200 μg

    Participants will receive single 200 μg doses given as 2x100 μg (ex-valve) at 20-second intervals. The intervention period will be 10 days with dosing with either HFA-152a or HFA-134a on Day 1, Day 4, Day 7, and Day 10.

    Drug: Salbutamol HFA-152a · Drug: Salbutamol HFA-134a

  • Experimental
    Cohort 2: Salbutamol 800 μg

    Participants will receive single 800 μg doses given as 8x100 μg (ex-valve) at 20-second intervals. The intervention period will be 10 days with dosing with either HFA-152a or HFA-134a on Day 1, Day 4, Day 7, and Day 10.

    Drug: Salbutamol HFA-152a · Drug: Salbutamol HFA-134a

Interventions

  • DrugSalbutamol HFA-152a

    100 µg (ex-valve), given at 20-second intervals.

  • DrugSalbutamol HFA-134a

    100 µg (ex-valve), given at 20-second intervals.

06

What researchers measure

Primary outcomes

  1. Cohort 1: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])

    Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  2. Cohort 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])

    Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  3. Cohort 1: Maximum Observed Plasma Concentration (Cmax)

    Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  4. Cohort 2: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])

    Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  5. Cohort 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])

    Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  6. Cohort 2: Maximum Observed Plasma Concentration (Cmax)

    Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

Secondary outcomes

  1. Cohort 1: Time to Reach Cmax (Tmax)

    Blood samples were collected for the analysis of PK parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  2. Cohort 1: Apparent Terminal Phase Half-life (t1/2)

    Blood samples were collected for the analysis of PK parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  3. Cohort 1: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])

    Blood samples were collected for the analysis of PK parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  4. Cohort 1-Intra-Participant Variability of AUC (0-30min)

    Blood samples were collected for the analysis of PK parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  5. Cohort 1: Intra Participant Variability of AUC (0-infinity)

    Blood samples were collected for the analysis of PK parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  6. Cohort 1: Intra Participant Variability of AUC(0-last)

    Blood samples were collected for the analysis of PK parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  7. Cohort 1: Intra Participant Variability of Cmax

    Blood samples were collected for the analysis of PK parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  8. Cohort 1: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    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. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect, abnormal pregnancy outcomes. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

    Time frame: Up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]

  9. Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)

    A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the HR and were measured after resting for at least 5 minutes in the supine position.

    Time frame: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)

  10. Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals

    A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.

    Time frame: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)

  11. Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR

    A standard 12 lead ECG was obtained using an ECG machine that automatically calculated HR and were measured after resting for at least 5 minutes in the supine position.

    Time frame: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)

  12. Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals

    A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.

    Time frame: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)

  13. Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count

    Blood samples were collected for analyzing absolute values of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet count. Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  14. Cohort 1: Absolute Values of Hematology Parameter: Erythrocytes

    Blood samples were collected for analyzing absolute values of Erythrocytes. Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  15. Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)

    Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV). Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  16. Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)

    Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH). Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  17. Cohort 1: Absolute Values of Hematology Parameter: Hemoglobin

    Blood samples were collected for analyzing absolute values of Hemoglobin. Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  18. Cohort 1: Absolute Values of Hematology Parameter: Hematocrit

    Blood samples were collected for analyzing absolute values of Hematocrit. Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  19. Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)

    Blood samples were collected for analyzing absolute values of Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Creatine Phosphokinase (CPK). Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  20. Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine

    Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin, total protein and Creatinine. Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  21. Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen

    Blood samples were collected for analyzing absolute values of Calcium, Sodium and Urea Nitrogen. Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  22. Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium

    Blood samples were collected for analyzing absolute values of glucose and potassium

    Time frame: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 1.5, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]

  23. Cohort 1: Absolute Values of 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. Manual techniques were used only if an automated device was not available.

    Time frame: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]

  24. Cohort 1: Absolute Values of Pulse Rate (PR)

    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. Manual techniques were used only if an automated device was not available.

    Time frame: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]

  25. Cohort 2: Time to Reach Cmax (Tmax)

    Blood samples were collected for the analysis of PK parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 [ Period 3] and Day 10 [Period 4]

  26. Cohort 2: Apparent Terminal Phase Half-life (t1/2)

    Blood samples were collected for the analysis of PK parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  27. Cohort 2: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])

    Blood samples were collected for the analysis of PK parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  28. Cohort 2-Intra-Participant Variability of AUC (0-30min)

    Blood samples were collected for the analysis of PK parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  29. Cohort 2: Intra Participant Variability of AUC (0-infinity)

    Blood samples were collected for the analysis of PK parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  30. Cohort 2: Intra Participant Variability of AUC (0-last)

    Blood samples were collected for the analysis of PK parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  31. Cohort 2: Intra Participant Variability of Cmax

    Blood samples were collected for the analysis of PK parameters.

    Time frame: At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

  32. Cohort 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    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. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect, abnormal pregnancy outcomes. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

    Time frame: Up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]

  33. Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)

    A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the HR and were measured after resting for at least 5 minutes in the supine position.

    Time frame: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)

  34. Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals

    A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.

    Time frame: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)

  35. Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR

    A standard 12 lead ECG was obtained using an ECG machine that automatically calculated HR and were measured after resting for at least 5 minutes in the supine position.

    Time frame: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)

  36. Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals

    A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.

    Time frame: Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)

  37. Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count

    Blood samples were collected for analyzing absolute values of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet count. Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  38. Cohort 2: Absolute Values of Hematology Parameter: Erythrocytes

    Blood samples were collected for analyzing absolute values of Erythrocytes. Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  39. Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)

    Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV). Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  40. Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)

    Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH). Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  41. Cohort 2: Absolute Values of Hematology Parameter: Hemoglobin

    Blood samples were collected for analyzing absolute values of Hemoglobin. Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  42. Cohort 2: Absolute Values of Hematology Parameter: Hematocrit

    Blood samples were collected for analyzing absolute values of Hematocrit. Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  43. Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)

    Blood samples were collected for analyzing absolute values of Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Creatine Phosphokinase (CPK). Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  44. Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine

    Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin, total protein and Creatinine. Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  45. Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen

    Blood samples were collected for analyzing absolute values of Calcium, Sodium and Urea Nitrogen. Baseline is defined as the latest non-missing pre-dose value

    Time frame: Baseline (Day -1) and Day 11 (Discharge)

  46. Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium

    Blood samples were collected for analyzing absolute values of glucose and potassium

    Time frame: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 1.5, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]

  47. Cohort 2: Absolute Values of 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. Manual techniques were used only if an automated device was not available.

    Time frame: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]

  48. Cohort 2: Absolute Values of Pulse Rate (PR)

    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. Manual techniques were used only if an automated device was not available.

    Time frame: Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]

07

Results

Posted Jan 12, 2026

Participant flow

Cohort 1 - Treatment Period 1 (Day 1)
Participant flow — Cohort 1 - Treatment Period 1 (Day 1)
MilestoneCohort 1: TRRT1Cohort 1: RTTR1Cohort 2: TRRT2Cohort 2: RTTR2
Started161400
Completed161400
Not completed0000
Cohort 1 - Treatment Period 2 (Day 4)
Participant flow — Cohort 1 - Treatment Period 2 (Day 4)
MilestoneCohort 1: TRRT1Cohort 1: RTTR1Cohort 2: TRRT2Cohort 2: RTTR2
Started161400
Completed161400
Not completed0000
Cohort 1 - Treatment Period 3 (Day 7)
Participant flow — Cohort 1 - Treatment Period 3 (Day 7)
MilestoneCohort 1: TRRT1Cohort 1: RTTR1Cohort 2: TRRT2Cohort 2: RTTR2
Started161400
Completed151300
Not completed1100
Withdrew: Withdrawal by subject1000
Withdrew: Physician decision0100
Cohort 1 - Treatment Period 4 (Day 10)
Participant flow — Cohort 1 - Treatment Period 4 (Day 10)
MilestoneCohort 1: TRRT1Cohort 1: RTTR1Cohort 2: TRRT2Cohort 2: RTTR2
Started151300
Completed151300
Not completed0000
Cohort 2 - Treatment Period 1 (Day 1)
Participant flow — Cohort 2 - Treatment Period 1 (Day 1)
MilestoneCohort 1: TRRT1Cohort 1: RTTR1Cohort 2: TRRT2Cohort 2: RTTR2
Started001416
Completed001416
Not completed0000
Cohort 2 - Treatment Period 2 (Day 4)
Participant flow — Cohort 2 - Treatment Period 2 (Day 4)
MilestoneCohort 1: TRRT1Cohort 1: RTTR1Cohort 2: TRRT2Cohort 2: RTTR2
Started001416
Completed001316
Not completed0010
Withdrew: Withdrawal by subject0010
Cohort 2 - Treatment Period 3 (Day 7)
Participant flow — Cohort 2 - Treatment Period 3 (Day 7)
MilestoneCohort 1: TRRT1Cohort 1: RTTR1Cohort 2: TRRT2Cohort 2: RTTR2
Started001316
Completed001316
Not completed0000
Cohort 2 - Treatment Period 4 (Day 10)
Participant flow — Cohort 2 - Treatment Period 4 (Day 10)
MilestoneCohort 1: TRRT1Cohort 1: RTTR1Cohort 2: TRRT2Cohort 2: RTTR2
Started001316
Completed001316
Not completed0000

Outcome measures

SecondaryCohort 1: Time to Reach Cmax (Tmax)

Blood samples were collected for the analysis of PK parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Median · Hour (h)
Cohort 1: Time to Reach Cmax (Tmax)
Hour (h)Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
Day 12.00 (0.3 to 3.0)2.0 (0.8 to 5.0)
Day 41.25 (0.3 to 5.0)1.00 (0.1 to 3.0)
Day 71.50 (0.2 to 4.0)1.50 (0.1 to 4.0)
Day 101.50 (0.3 to 5.0)1.00 (0.3 to 4.0)
SecondaryCohort 1: Apparent Terminal Phase Half-life (t1/2)

Blood samples were collected for the analysis of PK parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Mean · Hour (h)
Cohort 1: Apparent Terminal Phase Half-life (t1/2)
Hour (h)Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
Day 17.83 ± 1.0937.50 ± 1.731
Day 47.62 ± 0.9047.43 ± 1.546
Day 77.92 ± 2.2577.35 ± 1.388
Day 108.17 ± 1.3777.22 ± 1.319
SecondaryCohort 1: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])

Blood samples were collected for the analysis of PK parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Geometric least squares mean · h*pg/mL
Cohort 1: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])
h*pg/mLCohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
Cohort 1: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])5120.73 (4644.42 to 5645.89)3977.02 (3674.43 to 4304.54)
SecondaryCohort 1-Intra-Participant Variability of AUC (0-30min)

Blood samples were collected for the analysis of PK parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Number · Percentage of Coefficient Variation
Cohort 1-Intra-Participant Variability of AUC (0-30min)
Percentage of Coefficient VariationCohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
Cohort 1-Intra-Participant Variability of AUC (0-30min)36.328.7
SecondaryCohort 1: Intra Participant Variability of AUC (0-infinity)

Blood samples were collected for the analysis of PK parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Number · Percentage of Coefficient Variation
Cohort 1: Intra Participant Variability of AUC (0-infinity)
Percentage of Coefficient VariationCohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
Cohort 1: Intra Participant Variability of AUC (0-infinity)28.318.6
SecondaryCohort 1: Intra Participant Variability of AUC(0-last)

Blood samples were collected for the analysis of PK parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Number · Percentage of Coefficient Variation
Cohort 1: Intra Participant Variability of AUC(0-last)
Percentage of Coefficient VariationCohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
Cohort 1: Intra Participant Variability of AUC(0-last)28.518.3
SecondaryCohort 1: Intra Participant Variability of Cmax

Blood samples were collected for the analysis of PK parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Number · Percentage of Coefficient Variation
Cohort 1: Intra Participant Variability of Cmax
Percentage of Coefficient VariationCohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
Cohort 1: Intra Participant Variability of Cmax33.517.3
SecondaryCohort 1: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

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. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect, abnormal pregnancy outcomes. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

Time frame:
Up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Reported as:
Count of participants · Participants
Cohort 1: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
ParticipantsCohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 µg (Reference)
Any AE1812
Any SAE10
SecondaryCohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)

A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the HR and were measured after resting for at least 5 minutes in the supine position.

Time frame:
Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)
Reported as:
Mean · Beats per minute
Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Beats per minuteCohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
Baseline (Pre-dose at Day 1 [Period 1])55.1 ± 6.2552.7 ± 5.14
Post-dose at 30 minutes on Day 1 [Period 1]63.1 ± 7.0262.6 ± 7.56
Baseline (Pre-dose at Day 4 [Period 2])53.6 ± 6.3255.0 ± 8.06
Post-dose at 30 minutes on Day 4 [Period 2]62.3 ± 5.9862.8 ± 5.75
Baseline (Pre-dose at Day 7 [Period 3])55.4 ± 7.3756.6 ± 6.71
Post-dose at 30 minutes on Day 7 [Period 3]67.9 ± 9.7962.3 ± 8.68
Baseline (Pre-dose at Day 10 [Period 4])56.5 ± 6.8853.7 ± 5.03
Post-dose at 30 minutes on Day 10 [Period 4]64.9 ± 9.3164.2 ± 7.83
Day 11 (Discharge)60.7 ± 10.5961.2 ± 8.96
SecondaryCohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals

A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.

Time frame:
Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)
Reported as:
Mean · milliseconds (ms)
Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals
milliseconds (ms)Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
Baseline (Pre-dose at Day 1 [Period 1])403.0 ± 16.12411.6 ± 18.70
Post-dose at 30 minutes on Day 1 [Period 1]396.4 ± 15.50402.4 ± 16.22
Baseline (Pre-dose at Day 4 [Period 2])411.9 ± 18.94399.0 ± 15.77
Post-dose at 30 minutes on Day 4 [Period 2]400.4 ± 19.25393.1 ± 16.80
Baseline (Pre-dose at Day 7 [Period 3])412.4 ± 18.30397.4 ± 13.64
Post-dose at 30 minutes on Day 7 [Period 3]403.6 ± 19.66389.9 ± 12.09
Baseline (Pre-dose at Day 10 [Period 4])397.6 ± 13.14411.1 ± 18.06
Post-dose at 30 minutes on Day 10 [Period 4]392.7 ± 13.92399.8 ± 21.48
Day 11(Discharge)388.9 ± 14.24402.5 ± 19.75
SecondaryCohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR

A standard 12 lead ECG was obtained using an ECG machine that automatically calculated HR and were measured after resting for at least 5 minutes in the supine position.

Time frame:
Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)
Reported as:
Mean · Beats per minute
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
Beats per minuteCohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
CFB to Post-dose at 30 minutes on Day 1 [Period 1]8.0 ± 4.0310.0 ± 3.84
CFB to Post-dose at 30 minutes on Day 4 [Period 2]8.6 ± 3.47.8 ± 6.43
CFB to Post-dose at 30 minutes on Day 7 [Period 3]12.5 ± 7.625.7 ± 4.84
CFB to Post-dose at 30 minutes on Day 10 [Period 4]8.3 ± 5.7410.4 ± 4.79
CFB to Day 11 (Discharge)4.1 ± 7.257.5 ± 6.69
SecondaryCohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals

A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.

Time frame:
Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)
Reported as:
Mean · milliseconds (ms)
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
milliseconds (ms)Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
CFB to Post-dose at 30 minutes on Day 1 [Period 1]-6.6 ± 12.78-9.2 ± 6.89
CFB to Post-dose at 30 minutes on Day 4 [Period 2]-11.5 ± 4.83-5.9 ± 13.26
CFB to Post-dose at 30 minutes on Day 7 [Period 3]-8.9 ± 8.69-7.5 ± 9.04
CFB to Post-dose at 30 minutes on Day 10 [Period 4]-4.9 ± 12.68-11.3 ± 8.52
CFB to Day 11 (Discharge)-8.7 ± 9.29-8.5 ± 9.99
SecondaryCohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count

Blood samples were collected for analyzing absolute values of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet count. Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · Giga cells/Liter
Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Giga cells/LiterCohort 1: TRRT1Cohort 1: RTTR1
Neutrophils: Baseline (Day -1)3.62 ± 1.0583.32 ± 1.271
Neutrophils: Day 11 (Discharge)3.05 ± 0.8292.95 ± 0.918
Lymphocytes: Baseline (Day -1)2.07 ± 0.4371.97 ± 0.654
Lymphocytes: Day 11 (Discharge)2.08 ± 0.7071.88 ± 0.472
Monocytes: Baseline (Day -1)0.33 ± 0.0620.33 ± 0.075
Monocytes: Day 11 (Discharge)0.28 ± 0.0940.32 ± 0.080
Eosinophils: Baseline (Day -1)0.13 ± 0.0460.16 ± 0.077
Eosinophils: Day 11 (Discharge)0.11 ± 0.0350.15 ± 0.052
Basophils: Baseline (Day -1)0.03 ± 0.0490.05 ± 0.052
Basophils: Day 11 (Discharge)0.03 ± 0.0490.03 ± 0.048
Platelet count: Baseline (Day -1)254.9 ± 45.61262.8 ± 63.27
Platelet count: Day 11 (Discharge)252.1 ± 40.26230.6 ± 50.04
SecondaryCohort 1: Absolute Values of Hematology Parameter: Erythrocytes

Blood samples were collected for analyzing absolute values of Erythrocytes. Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · Trillion cells/Liter
Cohort 1: Absolute Values of Hematology Parameter: Erythrocytes
Trillion cells/LiterCohort 1: TRRT1Cohort 1: RTTR1
Baseline (Day -1)4.890 ± 0.44315.158 ± 0.4141
Day 11 (Discharge)4.516 ± 0.47104.753 ± 0.4655
SecondaryCohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)

Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV). Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · femtoliter (fL)
Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
femtoliter (fL)Cohort 1: TRRT1Cohort 1: RTTR1
Baseline (Day -1)91.1 ± 4.6192.1 ± 3.04
Day 11 (Discharge)90.0 ± 4.2691.6 ± 2.50
SecondaryCohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)

Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH). Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · femtomole (fmol)
Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
femtomole (fmol)Cohort 1: TRRT1Cohort 1: RTTR1
Baseline (Day -1)1.817 ± 0.09771.845 ± 0.0599
Day 11 (Discharge)1.823 ± 0.10771.841 ± 0.0640
SecondaryCohort 1: Absolute Values of Hematology Parameter: Hemoglobin

Blood samples were collected for analyzing absolute values of Hemoglobin. Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · gram per liter (g/L)
Cohort 1: Absolute Values of Hematology Parameter: Hemoglobin
gram per liter (g/L)Cohort 1: TRRT1Cohort 1: RTTR1
Baseline (Day -1)143.19 ± 14.903153.08 ± 11.699
Day 11 (Discharge)132.77 ± 14.593140.94 ± 12.026
SecondaryCohort 1: Absolute Values of Hematology Parameter: Hematocrit

Blood samples were collected for analyzing absolute values of Hematocrit. Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · Percentage of red blood cells in blood
Cohort 1: Absolute Values of Hematology Parameter: Hematocrit
Percentage of red blood cells in bloodCohort 1: TRRT1Cohort 1: RTTR1
Baseline (Day -1)0.445 ± 0.04050.475 ± 0.0355
Day 11 (Discharge)0.405 ± 0.04260.433 ± 0.0392
SecondaryCohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)

Blood samples were collected for analyzing absolute values of Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Creatine Phosphokinase (CPK). Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · International Units per Liter (IU/L)
Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
International Units per Liter (IU/L)Cohort 1: TRRT1Cohort 1: RTTR1
ALT: Baseline (Day -1)21.67 ± 9.10823.22 ± 10.178
ALT: Day 11 (Discharge)19.33 ± 5.32721.45 ± 8.102
ALP: Baseline (Day -1)65.4 ± 14.2673.1 ± 17.89
ALP: Day 11 (Discharge)60.5 ± 15.8564.4 ± 12.41
AST: Baseline (Day -1)12.38 ± 3.98414.52 ± 5.611
AST: Day 11 (Discharge)10.49 ± 3.01011.66 ± 4.240
CPK: Baseline (Day -1)103.1 ± 44.25120.4 ± 60.49
CPK: Day 11 (Discharge)88.1 ± 61.2879.9 ± 32.26
SecondaryCohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine

Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin, total protein and Creatinine. Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · micromoles per liter (umol/L)
Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
micromoles per liter (umol/L)Cohort 1: TRRT1Cohort 1: RTTR1
Direct Bilirubin: Baseline (Day -1)4.12 ± 2.2144.85 ± 2.035
Direct Bilirubin: Day 11 (Discharge)3.79 ± 2.0554.15 ± 1.531
Total Bilirubin: Baseline (Day -1)12.2 ± 6.2216.3 ± 7.10
Total Bilirubin: Day 11 (Discharge)11.8 ± 5.8213.8 ± 5.89
Total Protein: Baseline (Day -1)74.1 ± 3.7573.3 ± 4.19
Total Protein: Day 11 (Discharge)68.2 ± 3.5966.9 ± 3.40
Creatinine: Baseline (Day -1)63.3 ± 12.4873.6 ± 18.33
Creatinine: Day 11 (Discharge)62.1 ± 10.9269.4 ± 15.33
SecondaryCohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen

Blood samples were collected for analyzing absolute values of Calcium, Sodium and Urea Nitrogen. Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · millimoles per liter (mmol/L)
Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
millimoles per liter (mmol/L)Cohort 1: TRRT1Cohort 1: RTTR1
Calcium: Baseline (Day -1)2.388 ± 0.05612.431 ± 0.0656
Calcium: Day 11 (Discharge)2.300 ± 0.05152.306 ± 0.0678
Sodium: Baseline (Day -1)139.7 ± 2.31139.7 ± 1.38
Sodium: Day 11 (Discharge)139.7 ± 0.90140.3 ± 1.03
Urea Nitrogen: Baseline (Day -1)4.12 ± 0.9454.54 ± 1.149
Urea Nitrogen: Day 11 (Discharge)4.28 ± 0.8374.17 ± 0.832
SecondaryCohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium

Blood samples were collected for analyzing absolute values of glucose and potassium

Time frame:
Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 1.5, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]
Reported as:
Mean · millimoles per liter (mmol/L)
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
millimoles per liter (mmol/L)Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
Baseline (Pre-dose at Day 1 [Period 1]), Glucose4.76 ± 0.2064.89 ± 0.363
Day 1: Post-dose at 15 minutes (Period 1), Glucose4.97 ± 0.8034.60 ± 1.060
Day 1: Post-dose at 30 minutes (Period 1), Glucose4.86 ± 0.4534.71 ± 0.691
Day 1: Post-dose at 1 hour (Period 1), Glucose5.20 ± 0.7164.92 ± 0.415
Day 1: Post-dose at 1.5 hours (Period 1), Glucose4.99 ± 0.5094.86 ± 0.271
Day 1: Post-dose at 2 hours (Period 1), Glucose4.77 ± 0.3224.72 ± 0.356
Day 1: Post-dose at 4 hours (Period 1), Glucose4.50 ± 0.3104.49 ± 0.243
Baseline (Pre-dose at Day 4 [Period 2]), Glucose4.71 ± 0.2844.65 ± 0.237
Day 4: Post-dose at 15 minutes (Period 2), Glucose4.80 ± 0.7064.93 ± 0.758
Day 4: Post-dose at 30 minutes (Period 2), Glucose4.70 ± 0.5534.93 ± 0.588
Day 4: Post-dose at 1 hour (Period 2), Glucose4.84 ± 0.4454.91 ± 0.488
Day 4: Post-dose at 1.5 hours (Period 2), Glucose4.74 ± 0.3464.78 ± 0.431
Day 4: Post-dose at 2 hours (Period 2), Glucose4.71 ± 0.1964.61 ± 0.427
Day 4: Post-dose at 4 hours (Period 2), Glucose4.57 ± 0.2584.53 ± 0.355
Baseline (Pre-dose at Day 7 [Period 3]), Glucose4.63 ± 0.3074.59 ± 0.232
Day 7: Post-dose at 15 minutes (Period 3), Glucose4.66 ± 0.8525.02 ± 0.895
Day 7: Post-dose at 30 minutes (Period 3), Glucose4.56 ± 0.5774.88 ± 0.680
Day 7: Post-dose at 1 hour (Period 3), Glucose4.75 ± 0.3204.68 ± 0.449
Day 7: Post-dose at 1.5 hours (Period 3), Glucose4.76 ± 0.4144.72 ± 0.369
Day 7: Post-dose at 2 hours (Period 3), Glucose4.57 ± 0.3584.49 ± 0.286
Day 7: Post-dose at 4 hours (Period 3), Glucose4.51 ± 0.2364.51 ± 0.299
Baseline (Pre-dose at Day 10 (Period 4), Glucose4.62 ± 0.2834.66 ± 0.166
Day 10: Post-dose at 15 minutes (Period 4), Glucose4.97 ± 0.7014.99 ± 0.856
Day 10: Post-dose at 30 minutes (Period 4), Glucose4.90 ± 0.6504.98 ± 0.938
Day 10: Post-dose at 1 hour (Period 4), Glucose5.01 ± 0.4764.92 ± 0.518
Day 10: Post-dose at 1.5 hours (Period 4), Glucose4.60 ± 0.2804.86 ± 0.548
Day 10: Post-dose at 2 hours (Period 4), Glucose4.47 ± 0.2464.59 ± 0.278
Day 10: Post-dose at 4 hours (Period 4), Glucose4.55 ± 0.3044.48 ± 0.239
Baseline (Pre-dose at Day 1 [Period 1]), Potassium4.19 ± 0.2084.37 ± 0.289
Day 1: Post-dose at 15 minutes (Period 1), Potassium4.18 ± 0.2614.29 ± 0.244
Day 1: Post-dose at 30 minutes (Period 1), Potassium4.21 ± 0.3424.35 ± 0.241
Day 1: Post-dose at 1 hour (Period 1), Potassium4.16 ± 0.1754.24 ± 0.191
Day 1: Post-dose at 1.5 hours (Period 1), Potassium4.21 ± 0.1884.49 ± 0.487
Day 1: Post-dose at 2 hours (Period 1), Potassium4.20 ± 0.2194.21 ± 0.144
Day 1: Post-dose at 4 hours (Period 1), Potassium4.13 ± 0.2684.28 ± 0.255
Baseline (Pre-dose at Day 4 [Period 2]), Potassium4.33 ± 0.3674.46 ± 0.301
Day 4: Post-dose at 15 minutes (Period 2), Potassium4.47 ± 0.3074.21 ± 0.359
Day 4: Post-dose at 30 minutes (Period 2), Potassium4.27 ± 0.2054.37 ± 0.793
Day 4: Post-dose at 1 hour (Period 2), Potassium4.27 ± 0.1944.25 ± 0.264
Day 4: Post-dose at 1.5 hours (Period 2), Potassium4.20 ± 0.1964.24 ± 0.175
Day 4: Post-dose at 2 hours (Period 2), Potassium4.19 ± 0.1884.24 ± 0.213
Day 4: Post-dose at 4 hours (Period 2), Potassium4.12 ± 0.1674.26 ± 0.253
Baseline (Pre-dose at Day 7 [Period 3]), Potassium4.41 ± 0.3374.35 ± 0.228
Day 7: Post-dose at 15 minutes (Period 3), Potassium4.18 ± 0.2684.24 ± 0.294
Day 7: Post-dose at 30 minutes (Period 3), Potassium4.20 ± 0.2554.32 ± 0.256
Day 7: Post-dose at 1 hour (Period 3), Potassium4.18 ± 0.1254.16 ± 0.163
Day 7: Post-dose at 1.5 hours (Period 3), Potassium4.26 ± 0.2474.26 ± 0.328
Day 7: Post-dose at 2 hours (Period 3), Potassium4.12 ± 0.1194.26 ± 0.258
Day 7: Post-dose at 4 hours (Period 3), Potassium4.12 ± 0.3004.25 ± 0.327
Baseline (Pre-dose at Day 10 (Period 4), Potassium4.25 ± 0.2394.35 ± 0.282
Day 10: Post-dose at 15 minutes (Period 4), Potassium4.17 ± 0.1674.16 ± 0.185
Day 10: Post-dose at 30 minutes (Period 4), Potassium4.21 ± 0.3274.26 ± 0.214
Day 10: Post-dose at 1 hour (Period 4), Potassium4.22 ± 0.2584.15 ± 0.133
Day 10: Post-dose at 1.5 hours (Period 4), Potassium4.19 ± 0.2334.13 ± 0.144
Day 10: Post-dose at 2 hours (Period 4), Potassium4.15 ± 0.2004.13 ± 0.149
Day 10: Post-dose at 4 hours (Period 4), Potassium4.13 ± 0.1674.12 ± 0.141
SecondaryCohort 1: Absolute Values of 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. Manual techniques were used only if an automated device was not available.

Time frame:
Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]
Reported as:
Mean · millimeters of mercury (mmHg)
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
millimeters of mercury (mmHg)Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
Baseline (Pre-dose at Day 1 [Period 1]), SBP108.6 ± 6.83111.9 ± 7.24
Day 1: Post-dose at 15 minutes (Period 1), SBP109.9 ± 10.19113.9 ± 4.83
Day 1: Post-dose at 30 minutes (Period 1), SBP112.2 ± 8.84115.9 ± 6.54
Day 1: Post-dose at 1 hour (Period 1), SBP107.9 ± 11.74112.6 ± 7.75
Day 1: Post-dose at 2 hours (Period 1), SBP107.9 ± 9.39107.6 ± 6.55
Day 1: Post-dose at 4 hours (Period 1), SBP106.8 ± 9.02109.1 ± 7.92
Baseline (Pre-dose at Day 4 [Period 2]), SBP110.2 ± 10.16104.9 ± 8.99
Day 4: Post-dose at 15 minutes (Period 2), SBP113.6 ± 7.52108.3 ± 8.12
Day 4: Post-dose at 30 minutes (Period 2), SBP113.9 ± 7.53112.1 ± 11.79
Day 4: Post-dose at 1 hour (Period 2), SBP113.0 ± 9.99107.5 ± 7.69
Day 4: Post-dose at 2 hours (Period 2), SBP110.4 ± 11.66104.5 ± 8.93
Day 4: Post-dose at 4 hours (Period 2), SBP109.3 ± 9.00104.3 ± 9.29
Baseline (Pre-dose at Day 7 [Period 3]), SBP110.3 ± 8.09103.3 ± 9.75
Day 7: Post-dose at 15 minutes (Period 3), SBP111.8 ± 6.29106.4 ± 8.63
Day 7: Post-dose at 30 minutes (Period 3), SBP116.4 ± 7.55108.6 ± 10.65
Day 7: Post-dose at 1 hour (Period 3), SBP113.2 ± 7.16104.3 ± 7.67
Day 7: Post-dose at 2 hours (Period 3), SBP107.4 ± 8.38102.4 ± 9.85
Day 7: Post-dose at 4 hours (Period 3), SBP110.5 ± 7.89102.3 ± 9.26
Baseline (Pre-dose at Day 10 (Period 4), SBP108.0 ± 9.06111.2 ± 5.20
Day 10: Post-dose at 15 minutes (Period 4), SBP107.1 ± 9.63114.2 ± 10.43
Day 10: Post-dose at 30 minutes (Period 4), SBP109.1 ± 9.93115.2 ± 8.41
Day 10: Post-dose at 1 hour (Period 4), SBP106.7 ± 10.72112.6 ± 7.31
Day 10: Post-dose at 2 hours (Period 4), SBP104.5 ± 7.36106.1 ± 7.03
Day 10: Post-dose at 4 hours (Period 4), SBP105.1 ± 12.34110.3 ± 6.45
Baseline (Pre-dose at Day 1 [Period 1]), DBP65.6 ± 4.4767.8 ± 6.81
Day 1: Post-dose at 15 minutes (Period 1), DBP62.7 ± 6.1966.0 ± 3.84
Day 1: Post-dose at 30 minutes (Period 1), DBP65.5 ± 5.3266.4 ± 5.02
Day 1: Post-dose at 1 hour (Period 1), DBP62.7 ± 5.5663.0 ± 5.66
Day 1: Post-dose at 2 hours (Period 1), DBP63.4 ± 4.8463.5 ± 4.90
Day 1: Post-dose at 4 hours (Period 1), DBP63.3 ± 5.3563.4 ± 5.29
Baseline (Pre-dose at Day 4 [Period 2]), DBP64.1 ± 4.2465.3 ± 5.74
Day 4: Post-dose at 15 minutes (Period 2), DBP64.9 ± 4.1463.9 ± 6.46
Day 4: Post-dose at 30 minutes (Period 2), DBP63.9 ± 4.5164.8 ± 7.33
Day 4: Post-dose at 1 hour (Period 2), DBP62.1 ± 5.4663.8 ± 6.38
Day 4: Post-dose at 2 hours (Period 2), DBP63.3 ± 6.0963.3 ± 5.99
Day 4: Post-dose at 4 hours (Period 2), DBP61.4 ± 5.0262.9 ± 4.24
Baseline (Pre-dose at Day 7 [Period 3]), DBP68.1 ± 4.9165.0 ± 4.38
Day 7: Post-dose at 15 minutes (Period 3), DBP63.6 ± 5.5360.7 ± 5.19
Day 7: Post-dose at 30 minutes (Period 3), DBP64.7 ± 4.9162.3 ± 4.58
Day 7: Post-dose at 1 hour (Period 3), DBP64.4 ± 4.9460.9 ± 5.14
Day 7: Post-dose at 2 hours (Period 3), DBP60.7 ± 5.2262.3 ± 6.25
Day 7: Post-dose at 4 hours (Period 3), DBP63.9 ± 4.7561.6 ± 7.35
Baseline (Pre-dose at Day 10 (Period 4), DBP66.1 ± 6.4665.1 ± 3.99
Day 10: Post-dose at 15 minutes (Period 4), DBP63.4 ± 5.4464.6 ± 6.36
Day 10: Post-dose at 30 minutes (Period 4), DBP62.9 ± 5.1966.5 ± 6.70
Day 10: Post-dose at 1 hour (Period 4), DBP63.4 ± 5.8562.0 ± 4.16
Day 10: Post-dose at 2 hours (Period 4), DBP62.5 ± 5.9762.8 ± 4.93
Day 10: Post-dose at 4 hours (Period 4), DBP63.2 ± 8.7963.0 ± 3.92
SecondaryCohort 1: Absolute Values of Pulse Rate (PR)

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. Manual techniques were used only if an automated device was not available.

Time frame:
Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]
Reported as:
Mean · Beats per minute
Cohort 1: Absolute Values of Pulse Rate (PR)
Beats per minuteCohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
Baseline (Pre-dose at Day 1 [Period 1])55.7 ± 7.0751.1 ± 6.27
Day 1: Post-dose at 15 minutes (Period 1)63.9 ± 8.0765.3 ± 9.14
Day 1: Post-dose at 30 minutes (Period 1)61.9 ± 7.0263.6 ± 10.03
Day 1: Post-dose at 1 hour (Period 1)60.0 ± 7.8758.7 ± 7.25
Day 1: Post-dose at 2 hours (Period 1)57.7 ± 9.1754.9 ± 6.79
Day 1: Post-dose at 4 hours (Period 1)55.8 ± 7.2553.6 ± 6.25
Baseline (Pre-dose at Day 4 [Period 2])52.7 ± 7.1754.4 ± 8.55
Day 4: Post-dose at 15 minutes (Period 2)64.7 ± 5.3165.3 ± 6.87
Day 4: Post-dose at 30 minutes (Period 2)62.8 ± 6.6064.1 ± 4.44
Day 4: Post-dose at 1 hour (Period 2)62.1 ± 7.2459.3 ± 7.11
Day 4: Post-dose at 2 hours (Period 2)57.1 ± 5.2056.8 ± 8.64
Day 4: Post-dose at 4 hours (Period 2)57.1 ± 6.4157.9 ± 10.99
Baseline (Pre-dose at Day 7 [Period 3])54.7 ± 7.3456.8 ± 6.01
Day 7: Post-dose at 15 minutes (Period 3)69.2 ± 10.9865.6 ± 9.18
Day 7: Post-dose at 30 minutes (Period 3)65.3 ± 7.4362.6 ± 8.41
Day 7: Post-dose at 1 hour (Period 3)63.6 ± 7.6261.6 ± 6.73
Day 7: Post-dose at 2 hours (Period 3)59.0 ± 5.8057.5 ± 7.84
Day 7: Post-dose at 4 hours (Period 3)59.8 ± 5.7457.6 ± 9.26
Baseline (Pre-dose at Day 10 (Period 4)55.6 ± 8.5654.5 ± 5.61
Day 10: Post-dose at 15 minutes (Period 4)67.5 ± 7.2468.0 ± 9.70
Day 10: Post-dose at 30 minutes (Period 4)65.3 ± 9.8063.4 ± 7.98
Day 10: Post-dose at 1 hour (Period 4)63.7 ± 7.8262.1 ± 9.12
Day 10: Post-dose at 2 hours (Period 4)58.1 ± 6.9258.9 ± 8.41
Day 10: Post-dose at 4 hours (Period 4)58.6 ± 7.8156.8 ± 7.51
SecondaryCohort 2: Time to Reach Cmax (Tmax)

Blood samples were collected for the analysis of PK parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 [ Period 3] and Day 10 [Period 4]
Reported as:
Median · Hour
Cohort 2: Time to Reach Cmax (Tmax)
HourCohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
Day 11.50 (0.2 to 4.0)1.25 (0.3 to 2.0)
Day 41.50 (0.5 to 4.0)1.50 (0.3 to 5.0)
Day 71.50 (0.2 to 5.0)1.50 (0.3 to 4.0)
Day 101.50 (0.3 to 6.0)1.50 (0.1 to 4.0)
SecondaryCohort 2: Apparent Terminal Phase Half-life (t1/2)

Blood samples were collected for the analysis of PK parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Mean · Hour
Cohort 2: Apparent Terminal Phase Half-life (t1/2)
HourCohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
Day 18.56 ± 1.9457.73 ± 1.162
Day 47.65 ± 1.0227.79 ± 1.380
Day 77.61 ± 1.2477.57 ± 1.438
Day 107.87 ± 1.6787.74 ± 1.613
SecondaryCohort 2: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])

Blood samples were collected for the analysis of PK parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Geometric least squares mean · h*pg/mL
Cohort 2: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])
h*pg/mLCohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
Cohort 2: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])15345.11 (14137.58 to 16655.78)12840.80 (12011.17 to 13727.73)
SecondaryCohort 2-Intra-Participant Variability of AUC (0-30min)

Blood samples were collected for the analysis of PK parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Number · Percentage of Coefficient Variation
Cohort 2-Intra-Participant Variability of AUC (0-30min)
Percentage of Coefficient VariationCohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
Cohort 2-Intra-Participant Variability of AUC (0-30min)22.925.8
SecondaryCohort 2: Intra Participant Variability of AUC (0-infinity)

Blood samples were collected for the analysis of PK parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Number · Percentage of Coefficient Variation
Cohort 2: Intra Participant Variability of AUC (0-infinity)
Percentage of Coefficient VariationCohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
Cohort 2: Intra Participant Variability of AUC (0-infinity)10.08.6
SecondaryCohort 2: Intra Participant Variability of AUC (0-last)

Blood samples were collected for the analysis of PK parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Number · Percentage of Coefficient Variation
Cohort 2: Intra Participant Variability of AUC (0-last)
Percentage of Coefficient VariationCohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
Cohort 2: Intra Participant Variability of AUC (0-last)10.49.0
SecondaryCohort 2: Intra Participant Variability of Cmax

Blood samples were collected for the analysis of PK parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Number · Percentage of Coefficient Variation
Cohort 2: Intra Participant Variability of Cmax
Percentage of Coefficient VariationCohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
Cohort 2: Intra Participant Variability of Cmax14.112.2
SecondaryCohort 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

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. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect, abnormal pregnancy outcomes. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

Time frame:
Up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Reported as:
Count of participants · Participants
Cohort 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
ParticipantsCohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 µg (Reference)
Any AE2021
Any SAE00
SecondaryCohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)

A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the HR and were measured after resting for at least 5 minutes in the supine position.

Time frame:
Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)
Reported as:
Mean · Beats per minute
Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
Beats per minuteCohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
Baseline (Pre-dose at Day 1 [Period 1])63.9 ± 13.1053.2 ± 7.91
Post-dose at 30 minutes on Day 1 (Period 1)75.9 ± 14.2966.4 ± 7.27
Baseline (Pre-dose at Day 4 [Period 2])54.5 ± 7.7661.4 ± 9.38
Post-dose at 30 minutes on Day 4 (Period 2)66.7 ± 8.6776.4 ± 13.83
Baseline (Pre-dose at Day 7 [Period 3])55.1 ± 8.3864.1 ± 10.77
Post-dose at 30 minutes on Day 7 (Period 3)66.7 ± 8.6575.2 ± 10.17
Baseline (Pre-dose at Day 10 [Period 4])64.1 ± 9.0955.4 ± 8.04
Post-dose at 30 minutes on Day 10 (Period 4)77.1 ± 11.1168.4 ± 9.49
Day 11 (Discharge)67.8 ± 10.6859.4 ± 10.65
SecondaryCohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals

A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.

Time frame:
Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)
Reported as:
Mean · milliseconds (ms)
Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals
milliseconds (ms)Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
Baseline (Pre-dose at Day 1 [Period 1])407.8 ± 17.31399.9 ± 21.05
Post-dose at 30 minutes on Day 1 (Period 1)400.8 ± 17.71402.9 ± 18.43
Baseline (Pre-dose at Day 4 [Period 2])398.9 ± 25.14401.9 ± 17.55
Post-dose at 30 minutes on Day 4 (Period 2)399.6 ± 23.18401.9 ± 19.28
Baseline (Pre-dose at Day 7 [Period 3])399.9 ± 24.76402.7 ± 17.59
Post-dose at 30 minutes on Day 7 (Period 3)402.5 ± 23.59407.8 ± 24.84
Baseline (Pre-dose at Day 10 [Period 4])401.8 ± 15.07397.7 ± 22.86
Post-dose at 30 minutes on Day 10 (Period 4)400.2 ± 12.76400.6 ± 22.53
Day 11 (Discharge)395.9 ± 18.19391.2 ± 22.25
SecondaryCohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR

A standard 12 lead ECG was obtained using an ECG machine that automatically calculated HR and were measured after resting for at least 5 minutes in the supine position.

Time frame:
Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)
Reported as:
Mean · Beats per minute
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
Beats per minuteCohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
CFB to Post-dose at 30 minutes on Day 1 [Period 1]12.0 ± 8.4513.2 ± 4.51
CFB to Post-dose at 30 minutes on Day 4 [Period 2]12.2 ± 4.9915.0 ± 9.10
CFB to Post-dose at 30 minutes on Day 7 [Period 3]11.6 ± 4.5211.1 ± 4.51
CFB to Post-dose at 30 minutes on Day 10 [Period 4]12.9 ± 7.1713.0 ± 6.31
CFB to Day 11 (Discharge)3.7 ± 5.214.0 ± 4.81
SecondaryCohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals

A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.

Time frame:
Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)
Reported as:
Mean · milliseconds
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
millisecondsCohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
CFB to Post-dose at 30 minutes on Day 1 [Period 1]-7.0 ± 6.963.0 ± 10.59
CFB to Post-dose at 30 minutes on Day 4 [Period 2]0.7 ± 9.870.0 ± 14.23
CFB to Post-dose at 30 minutes on Day 7 [Period 3]2.6 ± 11.185.1 ± 16.88
CFB to Post-dose at 30 minutes on Day 10 [Period 4]-1.7 ± 5.522.9 ± 8.88
CFB to Day 11 (Discharge)-5.9 ± 9.40-6.5 ± 8.79
SecondaryCohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count

Blood samples were collected for analyzing absolute values of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet count. Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · Giga cells/Liter
Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Giga cells/LiterCohort 2: TRRT2Cohort 2: RTTR2
Neutrophils: Baseline (Day -1)4.56 ± 1.5633.11 ± 0.559
Neutrophils: Day 11 (Discharge)4.20 ± 1.3442.81 ± 0.521
Lymphocytes: Baseline (Day -1)2.17 ± 0.3972.01 ± 0.359
Lymphocytes: Day 11 (Discharge)2.05 ± 0.4311.98 ± 0.340
Monocytes: Baseline (Day -1)0.35 ± 0.1130.34 ± 0.089
Monocytes: Day 11 (Discharge)0.34 ± 0.0960.33 ± 0.095
Eosinophils: Baseline (Day -1)0.12 ± 0.0440.13 ± 0.060
Eosinophils: Day 11 (Discharge)0.15 ± 0.0520.16 ± 0.150
Basophils: Baseline (Day -1)0.03 ± 0.0480.02 ± 0.040
Basophils: Day 11 (Discharge)0.00 ± 0.0000.01 ± 0.025
Platelet count: Baseline (Day -1)276.1 ± 49.55219.3 ± 46.78
Platelet count: Day 11 (Discharge)280.5 ± 67.17221.3 ± 53.04
SecondaryCohort 2: Absolute Values of Hematology Parameter: Erythrocytes

Blood samples were collected for analyzing absolute values of Erythrocytes. Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · Trillion cells/Liter
Cohort 2: Absolute Values of Hematology Parameter: Erythrocytes
Trillion cells/LiterCohort 2: TRRT2Cohort 2: RTTR2
Baseline (Day -1)5.028 ± 0.62235.038 ± 0.4072
Day 11 (Discharge)4.575 ± 0.56694.826 ± 0.4039
SecondaryCohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)

Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV). Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · femtoliter (fL)
Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
femtoliter (fL)Cohort 2: TRRT2Cohort 2: RTTR2
Baseline (Day -1)89.8 ± 4.1091.3 ± 4.51
Day 11 (Discharge)90.3 ± 3.9991.4 ± 4.21
SecondaryCohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)

Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH). Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · femtomole (fmol)
Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
femtomole (fmol)Cohort 2: TRRT2Cohort 2: RTTR2
Baseline (Day -1)1.834 ± 0.08681.851 ± 0.0808
Day 11 (Discharge)1.837 ± 0.09801.853 ± 0.0919
SecondaryCohort 2: Absolute Values of Hematology Parameter: Hemoglobin

Blood samples were collected for analyzing absolute values of Hemoglobin. Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · gram per liter (g/L)
Cohort 2: Absolute Values of Hematology Parameter: Hemoglobin
gram per liter (g/L)Cohort 2: TRRT2Cohort 2: RTTR2
Baseline (Day -1)148.25 ± 18.566149.95 ± 11.278
Day 11 (Discharge)134.99 ± 16.590143.73 ± 12.170
SecondaryCohort 2: Absolute Values of Hematology Parameter: Hematocrit

Blood samples were collected for analyzing absolute values of Hematocrit. Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · Percentage of red blood cells in blood
Cohort 2: Absolute Values of Hematology Parameter: Hematocrit
Percentage of red blood cells in bloodCohort 2: TRRT2Cohort 2: RTTR2
Baseline (Day -1)0.450 ± 0.05370.458 ± 0.0338
Day 11 (Discharge)0.412 ± 0.04870.440 ± 0.0344
SecondaryCohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)

Blood samples were collected for analyzing absolute values of Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Creatine Phosphokinase (CPK). Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · International Units per Liter (IU/L)
Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
International Units per Liter (IU/L)Cohort 2: TRRT2Cohort 2: RTTR2
Baseline (Day -1), ALT19.15 ± 10.38323.88 ± 11.661
Day 11 (Discharge), ALT21.22 ± 9.94525.63 ± 18.822
Baseline (Day -1), ALP64.1 ± 14.9462.6 ± 22.40
Day 11 (Discharge), ALP59.8 ± 12.9460.1 ± 20.92
Baseline (Day -1), AST11.13 ± 3.26114.62 ± 7.533
Day 11 (Discharge), AST10.12 ± 2.48113.72 ± 13.046
Baseline (Day -1), CPK87.8 ± 47.25152.8 ± 72.50
Day 11 (Discharge), CPK60.9 ± 22.9190.0 ± 34.09
SecondaryCohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine

Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin, total protein and Creatinine. Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · micromoles per liter (umol/L)
Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
micromoles per liter (umol/L)Cohort 2: TRRT2Cohort 2: RTTR2
Baseline (Day -1), Direct Bilirubin3.75 ± 2.0214.68 ± 2.537
Day 11 (Discharge), Direct Bilirubin3.58 ± 2.5234.18 ± 2.461
Baseline (Day -1), Total Bilirubin16.7 ± 16.4516.1 ± 9.16
Day 11 (Discharge), Total Bilirubin11.8 ± 8.6513.9 ± 8.43
Baseline (Day -1), Total Protein74.8 ± 2.4171.8 ± 3.69
Day 11 (Discharge), Total Protein68.0 ± 3.1468.6 ± 4.38
Baseline (Day -1), Creatinine64.8 ± 12.6971.9 ± 12.30
Day 11 (Discharge), Creatinine61.6 ± 12.9171.4 ± 12.77
SecondaryCohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen

Blood samples were collected for analyzing absolute values of Calcium, Sodium and Urea Nitrogen. Baseline is defined as the latest non-missing pre-dose value

Time frame:
Baseline (Day -1) and Day 11 (Discharge)
Reported as:
Mean · millimoles per liter (mmol/L)
Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
millimoles per liter (mmol/L)Cohort 2: TRRT2Cohort 2: RTTR2
Baseline (Day -1), Calcium2.422 ± 0.12482.388 ± 0.0683
Day 11 (Discharge), Calcium2.313 ± 0.05982.341 ± 0.1008
Baseline (Day -1), Sodium138.8 ± 1.69139.1 ± 2.35
Day 11 (Discharge), Sodium139.8 ± 1.77140.4 ± 1.55
Baseline (Day -1), Urea Nitrogen4.33 ± 1.6375.39 ± 0.998
Day 11 (Discharge), Urea Nitrogen4.18 ± 0.8774.38 ± 0.913
SecondaryCohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium

Blood samples were collected for analyzing absolute values of glucose and potassium

Time frame:
Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 1.5, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]
Reported as:
Mean · millimoles per liter (mmol/L)
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
millimoles per liter (mmol/L)Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
Baseline (Pre-dose at Day 1 [Period 1]), Glucose4.84 ± 0.3034.99 ± 0.336
Day 1: Post-dose at 15 minutes (Period 1), Glucose5.04 ± 0.8044.96 ± 1.030
Day 1: Post-dose at 30 minutes (Period 1), Glucose5.08 ± 0.5584.96 ± 0.623
Day 1: Post-dose at 1 hour (Period 1), Glucose5.26 ± 0.4034.96 ± 0.320
Day 1: Post-dose at 1.5 hours (Period 1), Glucose5.09 ± 0.4744.98 ± 0.277
Day 1: Post-dose at 2 hours (Period 1), Glucose4.94 ± 0.4224.88 ± 0.349
Day 1: Post-dose at 4 hours (Period 1), Glucose4.59 ± 0.2974.74 ± 0.239
Baseline (Pre-dose at Day 4 [Period 2]), Glucose4.81 ± 0.2534.74 ± 0.334
Day 4: Post-dose at 15 minutes (Period 2), Glucose4.97 ± 1.6054.72 ± 0.998
Day 4: Post-dose at 30 minutes (Period 2), Glucose4.89 ± 1.0564.96 ± 0.658
Day 4: Post-dose at 1 hour (Period 2), Glucose4.88 ± 0.4734.97 ± 0.397
Day 4: Post-dose at 1.5 hours (Period 2), Glucose4.92 ± 0.5504.78 ± 0.444
Day 4: Post-dose at 2 hours (Period 2), Glucose4.74 ± 0.3344.54 ± 0.371
Day 4: Post-dose at 4 hours (Period 2), Glucose4.66 ± 0.2254.52 ± 0.308
Baseline (Pre-dose at Day 7 [Period 3]), Glucose4.84 ± 0.2424.72 ± 0.368
Day 7: Post-dose at 15 minutes (Period 3), Glucose5.01 ± 0.9365.07 ± 0.948
Day 7: Post-dose at 30 minutes (Period 3), Glucose4.75 ± 0.5165.05 ± 0.715
Day 7: Post-dose at 1 hour (Period 3), Glucose4.84 ± 0.4265.05 ± 0.425
Day 7: Post-dose at 1.5 hours (Period 3), Glucose4.73 ± 0.3825.02 ± 0.400
Day 7: Post-dose at 2 hours (Period 3), Glucose4.66 ± 0.3594.68 ± 0.383
Day 7: Post-dose at 4 hours (Period 3), Glucose4.71 ± 0.1544.57 ± 0.315
Baseline (Pre-dose at Day 10 (Period 4), Glucose4.67 ± 0.2934.83 ± 0.286
Day 10: Post-dose at 15 minutes (Period 4), Glucose4.62 ± 0.8875.23 ± 1.006
Day 10: Post-dose at 30 minutes (Period 4), Glucose4.77 ± 0.7864.91 ± 0.692
Day 10: Post-dose at 1 hour (Period 4), Glucose4.88 ± 0.2854.79 ± 0.512
Day 10: Post-dose at 1.5 hours (Period 4), Glucose4.81 ± 0.4114.73 ± 0.368
Day 10: Post-dose at 2 hours (Period 4), Glucose4.62 ± 0.3494.66 ± 0.316
Day 10: Post-dose at 4 hours (Period 4), Glucose4.59 ± 0.3554.68 ± 0.235
Baseline (Pre-dose at Day 1 [Period 1]), Potassium4.28 ± 0.2124.39 ± 0.295
Day 1: Post-dose at 15 minutes (Period 1), Potassium4.36 ± 0.3654.32 ± 0.128
Day 1: Post-dose at 30 minutes (Period 1), Potassium4.25 ± 0.3014.37 ± 0.296
Day 1: Post-dose at 1 hour (Period 1), Potassium4.22 ± 0.3454.23 ± 0.140
Day 1: Post-dose at 1.5 hours (Period 1), Potassium4.20 ± 0.2774.28 ± 0.402
Day 1: Post-dose at 2 hours (Period 1), Potassium4.30 ± 0.4994.16 ± 0.131
Day 1: Post-dose at 4 hours (Period 1), Potassium4.12 ± 0.1424.06 ± 0.163
Baseline (Pre-dose at Day 4 [Period 2]), Potassium4.28 ± 0.1914.29 ± 0.209
Day 4: Post-dose at 15 minutes (Period 2), Potassium4.37 ± 0.2354.10 ± 0.321
Day 4: Post-dose at 30 minutes (Period 2), Potassium4.31 ± 0.2414.38 ± 0.561
Day 4: Post-dose at 1 hour (Period 2), Potassium4.19 ± 0.1614.20 ± 0.238
Day 4: Post-dose at 1.5 hours (Period 2), Potassium4.11 ± 0.1394.27 ± 0.371
Day 4: Post-dose at 2 hours (Period 2), Potassium4.25 ± 0.5154.13 ± 0.206
Day 4: Post-dose at 4 hours (Period 2), Potassium4.14 ± 0.2714.18 ± 0.241
Baseline (Pre-dose at Day 7 [Period 3]), Potassium4.28 ± 0.1424.30 ± 0.153
Day 7: Post-dose at 15 minutes (Period 3), Potassium4.13 ± 0.1534.25 ± 0.185
Day 7: Post-dose at 30 minutes (Period 3), Potassium4.21 ± 0.2164.31 ± 0.218
Day 7: Post-dose at 1 hour (Period 3), Potassium4.14 ± 0.1784.19 ± 0.278
Day 7: Post-dose at 1.5 hours (Period 3), Potassium4.27 ± 0.6134.18 ± 0.244
Day 7: Post-dose at 2 hours (Period 3), Potassium4.12 ± 0.1804.28 ± 0.339
Day 7: Post-dose at 4 hours (Period 3), Potassium4.12 ± 0.2794.20 ± 0.183
Baseline (Pre-dose at Day 10 (Period 4), Potassium4.52 ± 0.4404.35 ± 0.234
Day 10: Post-dose at 15 minutes (Period 4), Potassium4.22 ± 0.2494.29 ± 0.294
Day 10: Post-dose at 30 minutes (Period 4), Potassium4.40 ± 0.4224.26 ± 0.193
Day 10: Post-dose at 1 hour (Period 4), Potassium4.22 ± 0.2314.20 ± 0.171
Day 10: Post-dose at 1.5 hours (Period 4), Potassium4.17 ± 0.1804.13 ± 0.134
Day 10: Post-dose at 2 hours (Period 4), Potassium4.22 ± 0.2284.07 ± 0.162
Day 10: Post-dose at 4 hours (Period 4), Potassium4.15 ± 0.1944.12 ± 0.256
SecondaryCohort 2: Absolute Values of 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. Manual techniques were used only if an automated device was not available.

Time frame:
Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]
Reported as:
Mean · millimeters of mercury(mmHg)
Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
millimeters of mercury(mmHg)Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
Baseline (Pre-dose at Day 1 [Period 1]), SBP109.9 ± 8.61108.3 ± 6.78
Day 1: Post-dose at 15 minutes (Period 1), SBP114.9 ± 12.04113.8 ± 9.52
Day 1: Post-dose at 30 minutes (Period 1), SBP114.6 ± 9.50113.8 ± 8.71
Day 1: Post-dose at 1 hour (Period 1), SBP110.4 ± 8.25110.8 ± 9.66
Day 1: Post-dose at 2 hours (Period 1), SBP106.9 ± 8.09110.4 ± 11.43
Day 1: Post-dose at 4 hours (Period 1), SBP109.4 ± 7.37109.1 ± 7.05
Baseline (Pre-dose at Day 4 [Period 2]), SBP106.9 ± 10.16106.6 ± 8.20
Day 4: Post-dose at 15 minutes (Period 2), SBP111.7 ± 10.44115.2 ± 11.87
Day 4: Post-dose at 30 minutes (Period 2), SBP111.3 ± 11.47116.4 ± 11.17
Day 4: Post-dose at 1 hour (Period 2), SBP110.9 ± 9.21110.6 ± 9.87
Day 4: Post-dose at 2 hours (Period 2), SBP105.8 ± 7.30105.4 ± 7.95
Day 4: Post-dose at 4 hours (Period 2), SBP108.8 ± 9.64109.2 ± 10.94
Baseline (Pre-dose at Day 7 [Period 3]), SBP109.9 ± 8.04107.5 ± 8.03
Day 7: Post-dose at 15 minutes (Period 3), SBP112.9 ± 12.96112.8 ± 9.89
Day 7: Post-dose at 30 minutes (Period 3), SBP112.8 ± 10.05114.1 ± 8.71
Day 7: Post-dose at 1 hour (Period 3), SBP110.4 ± 9.05108.4 ± 9.77
Day 7: Post-dose at 2 hours (Period 3), SBP107.8 ± 8.63105.7 ± 7.90
Day 7: Post-dose at 4 hours (Period 3), SBP109.4 ± 7.44108.8 ± 8.04
Baseline (Pre-dose at Day 10 (Period 4), SBP108.8 ± 7.06108.4 ± 10.20
Day 10: Post-dose at 15 minutes (Period 4), SBP113.5 ± 12.44113.9 ± 12.37
Day 10: Post-dose at 30 minutes (Period 4), SBP110.8 ± 8.47112.9 ± 11.75
Day 10: Post-dose at 1 hour (Period 4), SBP110.1 ± 11.02111.6 ± 10.18
Day 10: Post-dose at 2 hours (Period 4), SBP105.3 ± 9.70108.4 ± 8.34
Day 10: Post-dose at 4 hours (Period 4), SBP106.5 ± 9.90108.6 ± 8.02
Baseline (Pre-dose at Day 1 [Period 1]), DBP68.9 ± 7.0064.9 ± 3.59
Day 1: Post-dose at 15 minutes (Period 1), DBP66.2 ± 7.2962.6 ± 5.24
Day 1: Post-dose at 30 minutes (Period 1), DBP69.1 ± 6.7463.2 ± 3.82
Day 1: Post-dose at 1 hour (Period 1), DBP69.4 ± 7.2761.5 ± 5.18
Day 1: Post-dose at 2 hours (Period 1), DBP67.4 ± 6.5862.5 ± 5.25
Day 1: Post-dose at 4 hours (Period 1), DBP67.3 ± 6.2664.6 ± 5.78
Baseline (Pre-dose at Day 4 [Period 2]), DBP64.1 ± 6.5670.1 ± 7.09
Day 4: Post-dose at 15 minutes (Period 2), DBP61.4 ± 5.3366.5 ± 7.91
Day 4: Post-dose at 30 minutes (Period 2), DBP61.8 ± 7.1168.9 ± 8.53
Day 4: Post-dose at 1 hour (Period 2), DBP61.4 ± 4.3067.9 ± 8.11
Day 4: Post-dose at 2 hours (Period 2), DBP60.9 ± 4.5366.9 ± 5.88
Day 4: Post-dose at 4 hours (Period 2), DBP63.1 ± 5.4468.5 ± 7.45
Baseline (Pre-dose at Day 7 [Period 3]), DBP65.8 ± 5.3070.6 ± 7.83
Day 7: Post-dose at 15 minutes (Period 3), DBP63.0 ± 4.2667.5 ± 7.01
Day 7: Post-dose at 30 minutes (Period 3), DBP63.0 ± 4.5866.6 ± 6.50
Day 7: Post-dose at 1 hour (Period 3), DBP62.7 ± 3.4865.8 ± 7.96
Day 7: Post-dose at 2 hours (Period 3), DBP62.9 ± 3.9267.0 ± 5.12
Day 7: Post-dose at 4 hours (Period 3), DBP64.4 ± 4.7368.5 ± 7.48
Baseline (Pre-dose at Day 10 (Period 4), DBP67.6 ± 6.7664.9 ± 4.94
Day 10: Post-dose at 15 minutes (Period 4), DBP67.8 ± 7.7862.2 ± 6.75
Day 10: Post-dose at 30 minutes (Period 4), DBP67.0 ± 6.9261.1 ± 6.77
Day 10: Post-dose at 1 hour (Period 4), DBP66.8 ± 7.8362.8 ± 5.21
Day 10: Post-dose at 2 hours (Period 4), DBP66.2 ± 6.6262.5 ± 5.30
Day 10: Post-dose at 4 hours (Period 4), DBP66.0 ± 7.9761.1 ± 4.40
SecondaryCohort 2: Absolute Values of Pulse Rate (PR)

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. Manual techniques were used only if an automated device was not available.

Time frame:
Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]
Reported as:
Mean · Beats per minute
Cohort 2: Absolute Values of Pulse Rate (PR)
Beats per minuteCohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
Baseline (Pre-dose at Day 1 [Period 1])62.1 ± 11.5551.3 ± 8.75
Day 1: Post-dose at 15 minutes (Period 1)75.8 ± 13.4967.7 ± 8.24
Day 1: Post-dose at 30 minutes (Period 1)75.8 ± 14.8964.0 ± 9.15
Day 1: Post-dose at 1 hour (Period 1)73.0 ± 18.0261.1 ± 8.30
Day 1: Post-dose at 2 hours (Period 1)69.8 ± 13.2657.4 ± 8.33
Day 1: Post-dose at 4 hours (Period 1)66.6 ± 14.3156.4 ± 8.38
Baseline (Pre-dose at Day 4 [Period 2])56.4 ± 5.9062.1 ± 10.92
Day 4: Post-dose at 15 minutes (Period 2)67.1 ± 7.2277.6 ± 14.54
Day 4: Post-dose at 30 minutes (Period 2)64.8 ± 8.1274.8 ± 14.48
Day 4: Post-dose at 1 hour (Period 2)64.3 ± 8.2772.9 ± 11.04
Day 4: Post-dose at 2 hours (Period 2)60.0 ± 6.2967.1 ± 11.27
Day 4: Post-dose at 4 hours (Period 2)57.3 ± 7.5063.9 ± 9.84
Baseline (Pre-dose at Day 7 [Period 3])54.9 ± 8.2964.3 ± 11.12
Day 7: Post-dose at 15 minutes (Period 3)68.8 ± 7.9374.2 ± 11.67
Day 7: Post-dose at 30 minutes (Period 3)67.4 ± 8.3773.8 ± 11.78
Day 7: Post-dose at 1 hour (Period 3)65.7 ± 7.2972.9 ± 11.34
Day 7: Post-dose at 2 hours (Period 3)60.9 ± 6.5367.6 ± 10.22
Day 7: Post-dose at 4 hours (Period 3)56.9 ± 8.1967.1 ± 11.54
Baseline (Pre-dose at Day 10 (Period 4)65.5 ± 9.3654.0 ± 7.77
Day 10: Post-dose at 15 minutes (Period 4)77.2 ± 11.6369.3 ± 10.00
Day 10: Post-dose at 30 minutes (Period 4)77.2 ± 11.1867.9 ± 9.96
Day 10: Post-dose at 1 hour (Period 4)74.4 ± 10.4266.4 ± 8.71
Day 10: Post-dose at 2 hours (Period 4)70.2 ± 10.1661.4 ± 7.71
Day 10: Post-dose at 4 hours (Period 4)67.8 ± 10.2158.3 ± 6.93
PrimaryCohort 1: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])

Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Geometric least squares mean · Hour * Picogram per Milliliter (h*pg/mL)
Cohort 1: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])
Hour * Picogram per Milliliter (h*pg/mL)Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
Cohort 1: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])156.41 (135.32 to 180.79)162.11 (141.93 to 185.15)
Statistical analysis
  • Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) vs Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) · Ratio of geometric least squares mean: 0.9649 · 90% CI 0.8695 to 1.0707
PrimaryCohort 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])

Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20, 30, 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Geometric least squares mean · h*pg/mL
Cohort 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])
h*pg/mLCohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
Cohort 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])5734.92 (5214.16 to 6307.68)4431.63 (4102.67 to 4786.97)
Statistical analysis
  • Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) vs Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) · Ratio of geometric least squares mean: 1.2941 · 90% CI 1.1795 to 1.4199
PrimaryCohort 1: Maximum Observed Plasma Concentration (Cmax)

Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Geometric least squares mean · Picogram per milliliter (pg/mL)
Cohort 1: Maximum Observed Plasma Concentration (Cmax)
Picogram per milliliter (pg/mL)Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)
Cohort 1: Maximum Observed Plasma Concentration (Cmax)639.28 (578.69 to 706.20)518.51 (463.91 to 579.53)
Statistical analysis
  • Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) vs Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) · Ratio of geometric least squares mean: 1.2329 · 90% CI 1.1171 to 1.3608
PrimaryCohort 2: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])

Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Geometric least squares mean · Hour * Picogram per Milliliter (h*pg/mL)
Cohort 2: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])
Hour * Picogram per Milliliter (h*pg/mL)Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
Cohort 2: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])443.33 (374.78 to 524.43)467.88 (393.39 to 556.47)
Statistical analysis
  • Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test) vs Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference) · Ratio of geometric least squares mean: 0.9475 · 90% CI 0.7746 to 1.1590
PrimaryCohort 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])

Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20, 30, 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Geometric least squares mean · h*pg/mL
Cohort 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])
h*pg/mLCohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
Cohort 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])17098.45 (15794.52 to 18510.03)14210.59 (13339.71 to 15138.32)
Statistical analysis
  • Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test) vs Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference) · Ratio of geometric least squares mean: 1.2032 · 90% CI 1.1620 to 1.2459
PrimaryCohort 2: Maximum Observed Plasma Concentration (Cmax)

Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

Time frame:
At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Reported as:
Geometric least squares mean · Picogram per milliliter (pg/mL)
Cohort 2: Maximum Observed Plasma Concentration (Cmax)
Picogram per milliliter (pg/mL)Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
Cohort 2: Maximum Observed Plasma Concentration (Cmax)1891.30 (1741.29 to 2054.24)1677.79 (1545.53 to 1821.37)
Statistical analysis
  • Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test) vs Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference) · Ratio of geometric least squares mean: 1.1273 · 90% CI 1.0229 to 1.2423

Adverse events

Collected over Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)0/30 (0%)1/30 (3.3%)12/30 (40%)
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)0/30 (0%)0/30 (0%)7/30 (23.3%)
Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)0/30 (0%)0/30 (0%)16/30 (53.3%)
Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)0/30 (0%)0/29 (0%)21/30 (70%)
Most frequent serious events
Most frequent serious events
EventCohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
Conversion disorderPsychiatric disorders1/300/300/300/29
Most frequent other events
Showing 10 of 13
Most frequent other events
EventCohort 1: Salbutamol HFA-152a MDI 200 ug (Test)Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)
HeadacheNervous system disorders3/302/305/3010/30
Catheter site related reactionGeneral disorders0/300/309/309/30
Catheter site haematomaGeneral disorders5/301/300/300/30
FatigueGeneral disorders0/300/300/303/30
DizzinessNervous system disorders0/300/301/303/30
CoughRespiratory, thoracic and mediastinal disorders0/300/303/300/30
Catheter site irritationGeneral disorders2/302/300/300/30
Hot flushVascular disorders0/302/300/300/30
Oropharyngeal painRespiratory, thoracic and mediastinal disorders0/300/302/302/30
Paraesthesia oralGastrointestinal disorders0/300/302/301/30

Baseline characteristics

Age, Customized
Age, Customized(Participants)Cohort 1: TRRT1Cohort 1: RTTR1Cohort 2: TRRT2Cohort 2: RTTR2Total
18 to 55 years1614141660
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1: TRRT1Cohort 1: RTTR1Cohort 2: TRRT2Cohort 2: RTTR2Total
Female11710533
Male5741127
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort 1: TRRT1Cohort 1: RTTR1Cohort 2: TRRT2Cohort 2: RTTR2Total
American Indian or Alaska Native20002
Asian00101
Native Hawaiian or Other Pacific Islander00000
Black or African American00000
White1314131656
More than one race10001
Unknown or Not Reported00000
08

Study locations

1 site
  • GSK Investigational Site
    Groningen, 9728, Netherlands
09

References and documents

Study documents

  • Study protocol · May 2, 2024
  • Statistical analysis plan · Sep 25, 2024

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

Individual participant data

Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06433908
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
May 30, 2024
Start date
Jun 4, 2024
Primary completion
Oct 18, 2024
Completion
Oct 22, 2024
Results posted
Jan 12, 2026
Last update
Jan 12, 2026

Oversight

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

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

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