AsthmaPhase 1NCT05791565

Green (Sustainable) VENTOLIN - Pharmacokinetics (PK) Study in Healthy Participants

A Phase 1 study testing Salbutamol HFA-152a and Salbutamol HFA-134a in people with Asthma, 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

This study will be conducted to compare the PK of salbutamol administered via metered dose inhalers (MDI) containing propellants 1,1-difluroethane (HFA-152a) and 1,1,1,2-tetrafluoroethane (HFA-134a) in healthy participants. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Asthma
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: 28 participants
Where: 1 siteNetherlands
Study dates: 3 Apr 2023to 21 May 2023
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

Aged 18 to 55 years, inclusive, at screening
Body mass index 18.0 to 30.0 kilograms per meter square (kg/m^2), inclusive, at screening
Weight: greater than or equal to (>=)50 kg
At screening, females must not be pregnant or lactating, or of non-childbearing potential
Female participants of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception
Male participants, if not surgically sterilized, must agree to use adequate contraception
Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, electrocardiogram, and vital signs, as judged by the investigator
Willing and able to sign the informed consent form

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; constituting a risk when taking the study intervention or interfering with the interpretation of data
History or presence of any form of asthma, including childhood asthma and exercise induced asthma
Current enrollment or past participation in this clinical study
Participants with clinically significant abnormalities
A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse
Positive nasopharyngeal polymerase chain reaction test for severe acute respiratory syndrome-corona virus type 2 (SARS-CoV-2) on Day -1 or any known close contact with a person who tested positive for SARS-CoV-2 or with a coronavirus disease 2019 participant within 2 weeks prior to admission
Impairment which would prevent the correct and consistent use of an MDI, as determined by the investigator

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

GSK Investigational Site
Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: A Single Dose Two-way Cross-over Study in Healthy Participants to Compare the Pharmacokinetics (PK) of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152a and HFA-134a

Conditions: Asthma
Being tested: Salbutamol HFA-152a, Salbutamol HFA-134a
Keywords: Cross-over, Healthy volunteers, Salbutamol, Pharmacokinetics
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
Salbutamol HFA-152a will be administered.
Salbutamol HFA-134aDrug
Salbutamol HFA-134a will be administered.

Study groups in NCT05791565
Study group	Role	What they receive
Salbutamol HFA-152a MDI followed by Salbutamol HFA-134a MDI	Experimental	Participants will receive Salbutamol HFA-152a MDI in treatment period 1 followed by Salbutamol HFA-134a MDI in treatment period 2. There will be a minimum washout period of 72 hours between each treatment period. Receives: Drug: Salbutamol HFA-152a; Drug: Salbutamol HFA-134a
Salbutamol HFA-134a MDI followed by Salbutamol HFA-152a MDI	Experimental	Participants will receive Salbutamol HFA-134a MDI in treatment period 1 followed by Salbutamol HFA-152a MDI in treatment period 2. There will be a minimum washout period of 72 hours between each treatment period. 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.

Area Under the Plasma Concentration-time Curve up to 30 Minutes Post-dose (AUC (0-30 Min)) of Salbutamol
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose and post dose 3, 5, 10, 15, 20 and 30 minutes on Day 1 and Day 4
AUC From Time 0 to Infinity (AUC[0-inf]) of Salbutamol
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4
AUC From Time 0 to Time t (AUC[0-t]) of Salbutamol
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4
Maximum Observed Plasma Concentration (Cmax) of Salbutamol
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4

Secondary outcomes (27)

Time to Cmax (Tmax) of Salbutamol
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4
Apparent Terminal Phase Half-life (t1/2) of Salbutamol
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Measured: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4
Minimum Observed Serum Potassium Level (Emin, K) After Dosing of Salbutamol
Minimum observed concentration of potassium levels after dose are presented.
Measured: 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)
Weighted Mean Serum Potassium (0-4 Hour) (AUEC, K)
Weighed mean of serum potassium was calculated as summation of each interval. Each interval calculated as: (C2-C1)/2 * (t2-t1), where C2 and t2 are serum potassium and timepoint at the end of each interval, and C1 and t1 are serum potassium and timepoint at the start of each interval.
Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)
Maximum Observed Heart Rate (Emax, HR) After Dosing of Salbutamol
Maximum observed heart rate (HR) after dose is presented.
Measured: 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)
Weighted Mean Heart Rate (0-4 Hour) (AUEC, HR)
Weighed mean of HR was calculated as summation of each interval. Each interval calculated as: (C2-C1)/2 * (t2-t1), where C2 and t2 are HR and timepoint at the end of each interval, and C1 and t1 are HR and timepoint at the start of each interval.
Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)
Maximum Observed QTcF (Emax, QTcF) After Dosing of Salbutamol
Maximum observed QTcF after dose are presented.
Measured: 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)
Weighted Mean QTcF (0-4 Hour) (AUEC, QTcF)
Weighed mean of QTcF was calculated as summation of each interval. Each interval calculated as: [(C2+C1)/2×(t2-t1)]/Total time (Tlast-Tfirst, ie 4-0 hour) where C2 and t2 are concentration and timepoint at the end of each interval, and C1 and t1 are concentration and timepoint at the start of each interval. Tlast is the end of the last collection interval, and Tfirst is the start of the first collection interval.
Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pre-treatment or worsens relative to the pre-treatment state. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect. A summary of number of participants with any AEs and SAEs are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Measured: Up to 5 days
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline is defined as the last observation recorded before the first study drug administration in each dosing period.
Measured: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements.
Measured: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4
Absolute Values of ECG Parameter: Heart Rate
A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements.
Measured: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4
Change From Baseline in ECG Parameters: Heart Rate
A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements.
Measured: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Blood samples were collected for analyzing absolute values of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.
Measured: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count
Blood samples were collected for analyzing absolute values of red blood cell (RBC) and reticulocytes count.
Measured: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV).
Measured: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH).
Measured: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values of Hematology Parameter: Hemoglobin
Blood samples were collected for analyzing absolute values of Hemoglobin.
Measured: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values of Hematology Parameter: Hematocrit
Blood samples were collected for analyzing absolute values of Hematocrit.
Measured: On Day -1 (admission) and Day 5 (Discharge)
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).
Measured: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin and Creatinine.
Measured: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values of Clinical Chemistry Parameter: Total Protein
Blood samples were collected for analyzing absolute values of Total protein.
Measured: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)
Blood samples were collected for analyzing absolute values of Calcium, Sodium, Potassium, Blood Urea Nitrogen.
Measured: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values for Chemistry Parameter: Glucose
Blood samples were collected for analyzing absolute values of glucose.
Measured: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4
Number of Participants With Urinalysis Parameters by Dipstick Method
Urine samples were collected to assess glucose, ketones, occult blood, protein, urobilinogen and bilirubin by dipstick method. The dipstick test gave results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Results are presented as'(+)' indicating 'equivocal', '+' indicating 'trace amount', '++' indicating 'positive', and 'negative'.
Measured: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Blood pressure 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 at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4
Absolute Values of Pulse Rate
Pulse rate measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available.
Measured: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4

Timeline

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

3 Apr 202321 May 2023

First posted30 Mar 2023
Study start3 Apr 2023
Primary completion21 May 2023
Study completion21 May 2023

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: This is a 2-way cross-over study.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05791565
Sponsor's protocol ID: 219430
Status last verified: May 2024
First submitted: 17 Mar 2023
Last updated: 23 Sep 2024
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/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Dose Two-way Cross-over Study in Healthy Participants to Compare the Pharmacokinetics (PK) of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152a and HFA-134a
ClinicalTrials.gov ID: NCT05791565
Acronym / sponsor ID: 219430
Conditions: Asthma
Keywords: Cross-over, Healthy volunteers, Salbutamol, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 3 Apr 2023 (actual)
Primary completion: 21 May 2023 (actual)
Study completion: 21 May 2023 (actual)
First posted: 30 Mar 2023 (actual)
Results: Posted 23 Sep 2024

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: Double blind (participant, investigator)
Number of arms: 2
Model description: This is a 2-way cross-over study.

Arm	Type	Receives
Salbutamol HFA-152a MDI followed by Salbutamol HFA-134a MDI	Experimental	Drug: Salbutamol HFA-152a, Drug: Salbutamol HFA-134aParticipants will receive Salbutamol HFA-152a MDI in treatment period 1 followed by Salbutamol HFA-134a MDI in treatment period 2. There will be a minimum washout period of 72 hours between each treatment period.
Salbutamol HFA-134a MDI followed by Salbutamol HFA-152a MDI	Experimental	Drug: Salbutamol HFA-152a, Drug: Salbutamol HFA-134aParticipants will receive Salbutamol HFA-134a MDI in treatment period 1 followed by Salbutamol HFA-152a MDI in treatment period 2. There will be a minimum washout period of 72 hours between each treatment period.

Who may qualify

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

Key inclusion criteria (8 listed)

Aged 18 to 55 years, inclusive, at screening
Body mass index 18.0 to 30.0 kilograms per meter square (kg/m^2), inclusive, at screening
Weight: greater than or equal to (>=)50 kg
At screening, females must not be pregnant or lactating, or of non-childbearing potential
Female participants of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception

Key exclusion criteria (7 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; constituting a risk when taking the study intervention or interfering with the interpretation of data
History or presence of any form of asthma, including childhood asthma and exercise induced asthma
Current enrollment or past participation in this clinical study
Participants with clinically significant abnormalities
A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse

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-152aSalbutamol HFA-152a will be administered.	Drug	Salbutamol HFA-134a MDI followed by Salbutamol HFA-152a MDI, Salbutamol HFA-152a MDI followed by Salbutamol HFA-134a MDI
Salbutamol HFA-134aSalbutamol HFA-134a will be administered.	Drug	Salbutamol HFA-134a MDI followed by Salbutamol HFA-152a MDI, Salbutamol HFA-152a MDI followed by Salbutamol HFA-134a MDI

Primary outcome

Area Under the Plasma Concentration-time Curve up to 30 Minutes Post-dose (AUC (0-30 Min)) of Salbutamol
Time frame: Pre-dose and post dose 3, 5, 10, 15, 20 and 30 minutes on Day 1 and Day 4
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
AUC From Time 0 to Infinity (AUC[0-inf]) of Salbutamol
Time frame: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
AUC From Time 0 to Time t (AUC[0-t]) of Salbutamol
Time frame: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Maximum Observed Plasma Concentration (Cmax) of Salbutamol
Time frame: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.

27 secondary outcomes

Time to Cmax (Tmax) of Salbutamol
Time frame: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4
Apparent Terminal Phase Half-life (t1/2) of Salbutamol
Time frame: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4
Minimum Observed Serum Potassium Level (Emin, K) After Dosing of Salbutamol
Time frame: 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)
Weighted Mean Serum Potassium (0-4 Hour) (AUEC, K)
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)
Maximum Observed Heart Rate (Emax, HR) After Dosing of Salbutamol
Time frame: 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)
Weighted Mean Heart Rate (0-4 Hour) (AUEC, HR)
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)
Maximum Observed QTcF (Emax, QTcF) After Dosing of Salbutamol
Time frame: 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)
Weighted Mean QTcF (0-4 Hour) (AUEC, QTcF)
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 5 days
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval
Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval
Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4
Absolute Values of ECG Parameter: Heart Rate
Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4
Change From Baseline in ECG Parameters: Heart Rate
Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Time frame: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count
Time frame: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)
Time frame: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Time frame: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values of Hematology Parameter: Hemoglobin
Time frame: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values of Hematology Parameter: Hematocrit
Time frame: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)
Time frame: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Time frame: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values of Clinical Chemistry Parameter: Total Protein
Time frame: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN)
Time frame: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values for Chemistry Parameter: Glucose
Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4
Number of Participants With Urinalysis Parameters by Dipstick Method
Time frame: On Day -1 (admission) and Day 5 (Discharge)
Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4
Absolute Values of Pulse Rate
Time frame: Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4

Results and safety

Results posted to the registry on 23 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Salbutamol HFA-152a MDI Followed by Salbutamol HFA-134a MDI	14	14
Salbutamol HFA-134a MDI Followed by Salbutamol HFA-152a MDI	14	14

Primary outcome: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post-dose (AUC (0-30 Min)) of Salbutamol

Time frame: Pre-dose and post dose 3, 5, 10, 15, 20 and 30 minutes on Day 1 and Day 4. Geometric least squares mean (90% Confidence Interval). Unit: Hour*nanogram/milliliter (h*ng/mL)

Measure	Salbutamol HFA-152a MDI n = 27	Salbutamol HFA-134a MDI n = 27
Value	0.622 (0.535 to 0.724)	0.536 (0.461 to 0.623)

Salbutamol HFA-152a MDI vs Salbutamol HFA-134a MDI: Ratio of Geometric LS Means: 1.1609 (90% CI 1.0221 to 1.3185)

Population analysed: Pharmacokinetic population included all participants in the safety population who received at least one dose of study treatment and had at least one non-missing PK assessment. Only those participants with data available at specified time points have been analyzed. 1 participant in Salbutamol HFA-152a MDI arm had out of window samples resulting in two samples with the same collection time. Therefore, data could not be calculated and were excluded from the analysis.

Primary outcome: AUC From Time 0 to Infinity (AUC[0-inf]) of Salbutamol

Time frame: Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4. Geometric least squares mean (90% Confidence Interval). Unit: Hour*nanogram/milliliter (h*ng/mL)

Measure	Salbutamol HFA-152a MDI n = 27	Salbutamol HFA-134a MDI n = 27
Value	21.1 (19.7 to 22.6)	15.0 (14.0 to 16.1)

Salbutamol HFA-152a MDI vs Salbutamol HFA-134a MDI: Ratio of the Geometric LS Means: 1.4081 (90% CI 1.2998 to 1.5255)

Primary outcome: AUC From Time 0 to Time t (AUC[0-t]) of Salbutamol

Measure	Salbutamol HFA-152a MDI n = 27	Salbutamol HFA-134a MDI n = 27
Value	19.0 (17.7 to 20.5)	13.7 (12.7 to 14.7)

Salbutamol HFA-152a MDI vs Salbutamol HFA-134a MDI: Ratio of the Geometric LS Means: 1.3885 (90% CI 1.2793 to 1.5070)

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Salbutamol

Measure	Salbutamol HFA-152a MDI n = 27	Salbutamol HFA-134a MDI n = 27
Value	2.36 (2.15 to 2.60)	1.80 (1.63 to 1.97)

Salbutamol HFA-152a MDI vs Salbutamol HFA-134a MDI: Ratio of the Geometric LS Means: 1.3141 (90% CI 1.1816 to 1.4614)

27 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality, serious adverse events (SAEs) were collected from signing of the ICF, and all Adverse Events (AEs) were collected from start of study treatment up to Day 5 (discharge).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Salbutamol HFA-152a MDI	0 of 28 (0%)	6 of 28 (21.4%)	0 of 28
Salbutamol HFA-134a MDI	0 of 27 (0%)	8 of 27 (29.6%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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.

GSK Clinical Trials study director

GlaxoSmithKline

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, 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 8 inclusion and 7 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 23 Sep 2024. 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 23 Sep 2024). 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?

Area Under the Plasma Concentration-time Curve up to 30 Minutes Post-dose (AUC (0-30 Min)) of Salbutamol (time frame: Pre-dose and post dose 3, 5, 10, 15, 20 and 30 minutes on Day 1 and Day 4). The study lists 4 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 NCT05791565.

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 23 Sep 2024.