AsthmaPhase 1NCT06433908

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 study testing Salbutamol HFA-152a and Salbutamol HFA-134a in people with Asthma and Healthy Participants, run by GlaxoSmithKline at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Asthma, Healthy Participants
What is being tested?: Salbutamol HFA-152a and Salbutamol HFA-134a
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteNetherlands
Study dates: 4 Jun 2024to 22 Oct 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Sex: male or female; females may be of childbearing potential, of nonchild bearing potential, or postmenopausal.
Age: 18 to 55 years inclusive.
Weight: 45 to 110 kg inclusive
Status: healthy participants.
Females must not be pregnant or lactating.
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.

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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.
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.
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.
Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the investigator.
Serum potassium and serum glucose levels within reference ranges of the clinical research center.
Willing and able to sign the informed consent form.
Spirometry at screening demonstrating forced expiratory volume ≥80% predicted.

Who cannot join

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.
History or presence of any form of asthma, including childhood asthma and exercise induced asthma.
At screening, systolic blood pressure <90 mmHg or >140 mmHg, or diastolic blood pressure <50 mmHg or >90 mmHg.
History of pathological tachycardia, or a pulse rate > 85 beats per minute (bpm) at screening or Day-1.
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.
Breast cancer within the past 10 years.

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A QTcF value of >450 msec at screening based on a triplicate measurement taken at a single timepoint.
Vaccine(s) within 2 weeks prior to admission, or plans to receive such vaccines during the study.
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.
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.
Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Presence of hepatitis B surface antigen at screening or within 3 months prior to first dose of study intervention.
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.
Positive pre-study drug/alcohol screen, including tetrahydrocannabinol.
Positive HIV antibody test.
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.
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.
Regular use of known drugs of abuse, including tetrahydrocannabinol.
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.
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.).
Impairment which would prevent the correct and consistent use of an MDI, as determined by the investigator/delegate.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

GSK Investigational Site
Groningen, 9728

Other trials in Netherlands

About this study

Official title: A Phase 1, Randomized, Open-label, Single Dose, 2-treatment Arm (200 μg and 800 μg), 4-way Crossover Study in Healthy Participants Aged 18 to 55 to Compare the Pharmacokinetics of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152A (Test) and HFA-134A (Reference)

Conditions: Asthma, Healthy Participants
Being tested: Salbutamol HFA-152a, Salbutamol HFA-134a
Keywords: salbutamol, propellant HFA-152a, propellant HFA-134a, metered dose inhalers, healthy participants, asthma
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Salbutamol HFA-152aDrug
100 µg (ex-valve), given at 20-second intervals.
Salbutamol HFA-134aDrug
100 µg (ex-valve), given at 20-second intervals.

Study groups in NCT06433908
Study group	Role	What they receive
Cohort 1: Salbutamol 200 μg	Experimental	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. Receives: Drug: Salbutamol HFA-152a; Drug: Salbutamol HFA-134a
Cohort 2: Salbutamol 800 μg	Experimental	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. Receives: Drug: Salbutamol HFA-152a; Drug: Salbutamol HFA-134a

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
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.
Measured: 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)
Cohort 1: Maximum Observed Plasma Concentration (Cmax)
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Cohort 2: Maximum Observed Plasma Concentration (Cmax)
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Measured: 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 (48)

Cohort 1: Time to Reach Cmax (Tmax)
Blood samples were collected for the analysis of PK parameters.
Measured: 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)
Cohort 1: Apparent Terminal Phase Half-life (t1/2)
Blood samples were collected for the analysis of PK parameters.
Measured: 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)
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.
Measured: 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)
Cohort 1-Intra-Participant Variability of AUC (0-30min)
Blood samples were collected for the analysis of PK parameters.
Measured: 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)
Cohort 1: Intra Participant Variability of AUC (0-infinity)
Blood samples were collected for the analysis of PK parameters.
Measured: 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)
Cohort 1: Intra Participant Variability of AUC(0-last)
Blood samples were collected for the analysis of PK parameters.
Measured: 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)
Cohort 1: Intra Participant Variability of Cmax
Blood samples were collected for the analysis of PK parameters.
Measured: 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)
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.
Measured: Up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium
Blood samples were collected for analyzing absolute values of glucose and potassium
Measured: 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]
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.
Measured: 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]
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.
Measured: 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]
Cohort 2: Time to Reach Cmax (Tmax)
Blood samples were collected for the analysis of PK parameters.
Measured: 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]
Cohort 2: Apparent Terminal Phase Half-life (t1/2)
Blood samples were collected for the analysis of PK parameters.
Measured: 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)
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.
Measured: 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)
Cohort 2-Intra-Participant Variability of AUC (0-30min)
Blood samples were collected for the analysis of PK parameters.
Measured: 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)
Cohort 2: Intra Participant Variability of AUC (0-infinity)
Blood samples were collected for the analysis of PK parameters.
Measured: 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)
Cohort 2: Intra Participant Variability of AUC (0-last)
Blood samples were collected for the analysis of PK parameters.
Measured: 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)
Cohort 2: Intra Participant Variability of Cmax
Blood samples were collected for the analysis of PK parameters.
Measured: 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)
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.
Measured: Up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
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
Measured: Baseline (Day -1) and Day 11 (Discharge)
Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium
Blood samples were collected for analyzing absolute values of glucose and potassium
Measured: 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]
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.
Measured: 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]
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.
Measured: 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]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jun 202422 Oct 2024

First posted30 May 2024
Study start4 Jun 2024
Primary completion18 Oct 2024
Study completion22 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: 4-way crossover study.
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06433908
Sponsor's protocol ID: 219728
Other IDs: 2023-508279-36-00, 2023
Status last verified: Jan 2026
First submitted: 23 May 2024
Last updated: 12 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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/

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-label, Single Dose, 2-treatment Arm (200 μg and 800 μg), 4-way Crossover Study in Healthy Participants Aged 18 to 55 to Compare the Pharmacokinetics of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152A (Test) and HFA-134A (Reference)
ClinicalTrials.gov ID: NCT06433908
Acronym / sponsor ID: 219728
Conditions: Asthma, Healthy Participants
Keywords: salbutamol, propellant HFA-152a, propellant HFA-134a, metered dose inhalers, healthy participants, asthma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 4 Jun 2024 (actual)
Primary completion: 18 Oct 2024 (actual)
Study completion: 22 Oct 2024 (actual)
First posted: 30 May 2024 (actual)
Results: Posted 12 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: 4-way crossover study.

Arm	Type	Receives
Cohort 1: Salbutamol 200 μg	Experimental	Drug: Salbutamol HFA-152a, Drug: Salbutamol HFA-134aParticipants 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.
Cohort 2: Salbutamol 800 μg	Experimental	Drug: Salbutamol HFA-152a, Drug: Salbutamol HFA-134aParticipants 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Sex: male or female; females may be of childbearing potential, of nonchild bearing potential, or postmenopausal.
Age: 18 to 55 years inclusive.
Weight: 45 to 110 kg inclusive
Status: healthy participants.
Females must not be pregnant or lactating.

Key exclusion criteria (22 listed)

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.
History or presence of any form of asthma, including childhood asthma and exercise induced asthma.
At screening, systolic blood pressure <90 mmHg or >140 mmHg, or diastolic blood pressure <50 mmHg or >90 mmHg.
History of pathological tachycardia, or a pulse rate > 85 beats per minute (bpm) at screening or Day-1.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Salbutamol HFA-152a100 µg (ex-valve), given at 20-second intervals.	Drug	Cohort 1: Salbutamol 200 μg, Cohort 2: Salbutamol 800 μg
Salbutamol HFA-134a100 µg (ex-valve), given at 20-second intervals.	Drug	Cohort 1: Salbutamol 200 μg, Cohort 2: Salbutamol 800 μg

Primary outcome

Cohort 1: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])
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)
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Cohort 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])
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)
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Cohort 1: Maximum Observed Plasma Concentration (Cmax)
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)
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Cohort 2: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])
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)
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Cohort 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])
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)
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.
Cohort 2: Maximum Observed Plasma Concentration (Cmax)
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)
Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

48 secondary outcomes

Cohort 1: Time to Reach Cmax (Tmax)
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)
Cohort 1: Apparent Terminal Phase Half-life (t1/2)
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)
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])
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)
Cohort 1-Intra-Participant Variability of AUC (0-30min)
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)
Cohort 1: Intra Participant Variability of AUC (0-infinity)
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)
Cohort 1: Intra Participant Variability of AUC(0-last)
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)
Cohort 1: Intra Participant Variability of Cmax
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)
Cohort 1: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
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)
Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals
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)
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
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)
Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
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)
Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Cohort 1: Absolute Values of Hematology Parameter: Erythrocytes
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Cohort 1: Absolute Values of Hematology Parameter: Hemoglobin
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Cohort 1: Absolute Values of Hematology Parameter: Hematocrit
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Cohort 1: Absolute Values for Chemistry Parameter: 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]
Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
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]
Cohort 1: Absolute Values of Pulse Rate (PR)
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]
Cohort 2: Time to Reach Cmax (Tmax)
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]
Cohort 2: Apparent Terminal Phase Half-life (t1/2)
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)
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])
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)
Cohort 2-Intra-Participant Variability of AUC (0-30min)
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)
Cohort 2: Intra Participant Variability of AUC (0-infinity)
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)
Cohort 2: Intra Participant Variability of AUC (0-last)
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)
Cohort 2: Intra Participant Variability of Cmax
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)
Cohort 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]
Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
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)
Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals
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)
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR
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)
Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals
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)
Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Cohort 2: Absolute Values of Hematology Parameter: Erythrocytes
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
Time frame: Baseline (Day -1) and Day 11 (Discharge)
Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Time frame: Baseline (Day -1) and Day 11 (Discharge)

Results and safety

Results posted to the registry on 12 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: TRRT1	16	16
Cohort 1: RTTR1	14	14
Cohort 2: TRRT2	0	0
Cohort 2: RTTR2	0	0

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

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). Geometric least squares mean (95% Confidence Interval). Unit: Hour * Picogram per Milliliter (h*pg/mL)

Measure	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) n = 29	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) n = 29
Value	156.41 (135.32 to 180.79)	162.11 (141.93 to 185.15)

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)

Population analysed: Pharmacokinetic Population included all participants in the Full Analysis Set who had at least 1 non-missing assessment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

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

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). Geometric least squares mean (95% Confidence Interval). Unit: h*pg/mL

Measure	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) n = 30	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) n = 30
Value	5734.92 (5214.16 to 6307.68)	4431.63 (4102.67 to 4786.97)

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)

Population analysed: Pharmacokinetic Population

Primary outcome: Cohort 1: Maximum Observed Plasma Concentration (Cmax)

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). Geometric least squares mean (95% Confidence Interval). Unit: Picogram per milliliter (pg/mL)

Measure	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test) n = 30	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference) n = 30
Value	639.28 (578.69 to 706.20)	518.51 (463.91 to 579.53)

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)

Population analysed: Pharmacokinetic Population

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

Measure	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test) n = 30	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference) n = 29
Value	443.33 (374.78 to 524.43)	467.88 (393.39 to 556.47)

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)

Population analysed: Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

48 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	1 of 30 (3.3%)	12 of 30 (40%)	0 of 30
Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	0 of 30 (0%)	7 of 30 (23.3%)	0 of 30
Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	0 of 30 (0%)	16 of 30 (53.3%)	0 of 30
Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	0 of 29 (0%)	21 of 30 (70%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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/

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Salbutamol HFA-152a and Salbutamol HFA-134a in people with Asthma and Healthy Participants, run by GlaxoSmithKline at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30]) (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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06433908.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.