CompletedPhase 1

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

Netherlands60 participantsStarted 2024-06-04

Plain-language 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).

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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])

Timeframe: 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)

Timeframe: 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])

Timeframe: 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])

Trial details

NCT IDNCT06433908

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-18

Results submitted2025-10-17

View on ClinicalTrials.gov More Asthma trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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.

What they're measuring

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

Timeframe: 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])

Cohort 1: Maximum Observed Plasma Concentration (Cmax)

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

Timeframe: 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])

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria