AsthmaPhase 1NCT06433921
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
A Phase 1 study testing Salbutamol HFA-152a and Salbutamol HFA-134a in people with Asthma and Mild Asthma, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) [PC20]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma, Mild Asthma
- What is being tested?
- Salbutamol HFA-152a and Salbutamol HFA-134a
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Aug 2024to 16 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- Participant must be 18 to 65 years of age inclusive, at the time of screening.
- ≥50 kg, at the time of screening.
- Body mass index (BMI) with 19.0-35.0 kg/m2 inclusive, at the time of screening.
- 4. Documented history of asthma ≥ 6 months. 5. Receiving 1 of following asthma treatments, at a stable dose, for at least 12 weeks prior to the screening visit and is anticipated to remain stable for the duration of the study: i. Short-acting beta-agonist (SABA) only. ii. Daily maintenance low-dose inhaled corticosteroids (ICS) (defined as 100-250 μg/day fluticasone propionate or equivalent plus or minus SABA which is anticipated to remain stable for the duration of the study.
- Daily maintenance low-dose ICS + Long-acting beta-2 agonist (LABA) therapy (low-dose ICS defined as 100-250 μg/day fluticasone propionate or equivalent as defined by GINA [GINA, 2023]) plus or minus SABA, which is anticipated to remain stable for the duration of the study.
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- 6. No severe asthma exacerbations within 6 months prior to screening and ≤1 severe exacerbation during the 12 months prior to screening.
- 7. Pre-bronchodilator FEV1 ≥80% of predicted, at screening. 8. PC20 to methacholine of ≤8 mg/mL, at screening. 9. Participants should be able to withhold SABA for ≥12 hours and LABA-containing medications for ≥48 hours for the purposes of performing the spirometry and methacholine challenge at screening and during the study visits (treatment periods).
- 10. A female participant is eligible to participate if she is not pregnant or breastfeeding, and Is a woman of woman of nonchildbearing potential (WONCBP) OR ii. Is a woman of child bearing potential (WOCBP) and using a contraceptive method that is highly effective.
- 11. Provide signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
- 12. Non-smokers who have not used any tobacco containing-products within 12 months prior to study start, and with a total pack year history of ≤10 pack years.
Who cannot join
- Medical Conditions
- A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.
- A history of respiratory diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, cystic fibrosis, bronchiectasis, interstitial lung disease, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other respiratory abnormalities other than asthma.
- Asymptomatic gallstones.
- History or current evidence of hematologic, neurologic, psychiatric, or other diseases that, in the opinion of the investigator, would put the participant at risk through study participation, or would affect the study analyses if the disease exacerbates during the study.
- Recent eye surgery or any other condition in which raised intracranial pressure (caused by forceful exhalation) would be harmful.
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- Current use of cholinesterase inhibitor medication e.g., to treat myasthenia gravis.
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer.
- Participants who are currently or in the last 15 days have worked nightshifts.
- Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >21 units for males or >14 units for females.
- A positive test result for drugs of abuse (including tetrahydrocannabinol) at screening or Day -1.
- Use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to "vape" within 12 months prior to the start of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Manchester, Greater Manchester, M23 9QZ
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 1, Randomized, 2-part, 7-way Cross-over (Part 1) and 7-way Cross-over (Part 2), Blinded, Single Dose Study in Mild Asthmatics Aged 18-65 to Assess the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152a (Test) and HFA-134a (Reference) Via Methacholine Bronchoprovocation and Systemic Pharmacodynamic Effects
The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) [PC20]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. Part 2: to compare the comparative dose response on efficacy (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.
- Conditions
- Asthma, Mild Asthma
- Being tested
- Salbutamol HFA-152a, Salbutamol HFA-134a, Placebo
- Keywords
- Salbutamol, Propellant HFA-152a, Propellant HFA-134a, Metered dose inhalers, Mild 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
A single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals.
Salbutamol HFA-134aDrug
A single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals.
PlaceboDrug
A single placebo HFA-152a suspension or placebo HFA-134a suspension dose, given as at 20 second intervals.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Part 1 will consist of a 7 treatment, 7 period cross-over evaluation with all participants receiving the following treatments once, randomized to varying pre-specified sequences of:
* Zero dose (placebo of both salbutamol HFA-134a and salbutamol HFA-152a)
* 100 μg salbutamol HFA-134a
* 200 μg salbutamol HFA-134a
* 400 μg salbutamol HFA-134a
* 100 μg salbutamol HFA-152a
* 200 μg salbutamol HFA-152a
* 400 μg salbutamol HFA-152a
A minimum of a 2-day and maximum of a 7-day methacholine washout will separate each treatment period. Receives: Drug: Salbutamol HFA-152a; Drug: Salbutamol HFA-134a; Drug: Placebo |
| Part 2 | Experimental | Part 2 will consist of a 7 treatment, 7-way cross-over with all participants receiving the following treatments given once, randomized to varying pre-specified sequences of:
* Zero dose (placebo of both salbutamol HFA-134a and salbutamol HFA-152a)
* 100 μg salbutamol HFA-134a
* 200 μg salbutamol HFA-134a
* 400 μg salbutamol HFA-134a
* 100 μg salbutamol HFA-152a
* 200 μg salbutamol HFA-152a
* 400 μg salbutamol HFA-152a
A minimum of a 3-day and maximum of a 7-day methacholine washout will separate each treatment period. Receives: Drug: Salbutamol HFA-152a; Drug: Salbutamol HFA-134a; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 & Part 2: Provocative concentration of methacholine causing at least a 20% fall in FEV1 (PC20)
Measured: Up to 11 weeks
Secondary outcomes (14)
Part 1 & Part 2: Peak QTc Interval
Measured: Up to 11 weeks
Part 1 & Part 2: Peak Heart Rate (HR)
Measured: Up to 11 weeks
Part 1 & Part 2: Minimum Serum Potassium
Measured: Up to 11 weeks
Part 1: Maximum Observed Plasma Concentration (Cmax)
Measured: Up to 11 weeks
Part 1: Time to Reach Cmax (Tmax)
Measured: Up to 11 weeks
Part 1: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])
Measured: Up to 11 weeks
Part 1 & Part 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to 11 weeks
Part 1 & Part 2: Absolute Values for 12-lead Electrocardiogram (ECG) Recording of HR
Measured: Up to 11 weeks
Part 1 & Part 2: Absolute Values for 12-lead ECGs Recording of Intervals
Intervals recorded: - PR. - QRS. - QT. - QTc
Measured: Up to 11 weeks
Part 1 & Part 2: Change from Baseline for Post-dose 12-lead ECGs Recording of HR
The 3 predose measures will be recorded and will be averaged for HR to derive 1 baseline value.
Measured: Baseline and up to 11 weeks
Part 1 & Part 2: Change from Baseline for Post-dose 12-lead ECGs Recording of Intervals
The 3 predose measures will be recorded and will be averaged for QTc interval to derive 1 baseline value. Intervals recorded: - PR. - QRS. - QT. - QTc
Measured: Up to 11 weeks
Part 1 & Part 2: Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
Measured: Up to 11 weeks
Part 1 & Part 2: Absolute Values of Vital Signs (Systolic and Diastolic Blood Pressure)
Measured: Up to 11 weeks
Part 1 & Part 2: Absolute Values of Vital Signs (Pulse Rate)
Measured: Up to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start14 Aug 2024
- Primary completion16 Apr 2027 (estimated)
- Study completion16 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 2-part, 7-way cross- over (Part 1 and Part 2)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433921
- Sponsor's protocol ID
- 219729
- Other IDs
- 2024-511220-14, 2024-511220-14-00, 2024-511220-14-00
- Status last verified
- Nov 2026
- First submitted
- 23 May 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- 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/
Publications
Moreira S, Clow L, Coles-Piper E, Donald A, Janson C, Singh D, Slade D, Tiwari P, Weng S, Plank M. Developing low-carbon salbutamol MDI: assessment of relative bioavailability and pharmacodynamic relative potency of salbutamol MDI with propellant HFA-152a. BMJ Open Respir Res. 2026 Jun 17;13(1):e004036. doi: 10.1136/bmjresp-2025-004036.
PubMed 42309649
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, 2-part, 7-way Cross-over (Part 1) and 7-way Cross-over (Part 2), Blinded, Single Dose Study in Mild Asthmatics Aged 18-65 to Assess the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152a (Test) and HFA-134a (Reference) Via Methacholine Bronchoprovocation and Systemic Pharmacodynamic Effects
- ClinicalTrials.gov ID
- NCT06433921
- Acronym / sponsor ID
- 219729
- Conditions
- Asthma, Mild Asthma
- Keywords
- Salbutamol, Propellant HFA-152a, Propellant HFA-134a, Metered dose inhalers, Mild asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 16 Apr 2027 (estimated)
- Study completion
- 16 Apr 2027 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) [PC20]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. Part 2: to compare the comparative dose response on efficacy (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2-part, 7-way cross- over (Part 1 and Part 2)
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: Salbutamol HFA-152a, Drug: Salbutamol HFA-134a, Drug: PlaceboPart 1 will consist of a 7 treatment, 7 period cross-over evaluation with all participants receiving the following treatments once, randomized to varying pre-specified sequences of: * Zero dose (placebo of both salbutamol HFA-134a and salbutamol HFA-152a) * 100 μg salbutamol HFA-134a * 200 μg salbutamol HFA-134a * 400 μg salbutamol HFA-134a * 100 μg salbutamol HFA-152a * 200 μg salbutamol HFA-152a * 400 μg salbutamol HFA-152a A minimum of a 2-day and maximum of a 7-day methacholine washout will separate each treatment period. |
| Part 2 | Experimental | Drug: Salbutamol HFA-152a, Drug: Salbutamol HFA-134a, Drug: PlaceboPart 2 will consist of a 7 treatment, 7-way cross-over with all participants receiving the following treatments given once, randomized to varying pre-specified sequences of: * Zero dose (placebo of both salbutamol HFA-134a and salbutamol HFA-152a) * 100 μg salbutamol HFA-134a * 200 μg salbutamol HFA-134a * 400 μg salbutamol HFA-134a * 100 μg salbutamol HFA-152a * 200 μg salbutamol HFA-152a * 400 μg salbutamol HFA-152a A minimum of a 3-day and maximum of a 7-day methacholine washout will separate each treatment period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- Participant must be 18 to 65 years of age inclusive, at the time of screening.
- ≥50 kg, at the time of screening.
- Body mass index (BMI) with 19.0-35.0 kg/m2 inclusive, at the time of screening.
- 4. Documented history of asthma ≥ 6 months. 5. Receiving 1 of following asthma treatments, at a stable dose, for at least 12 weeks prior to the screening visit and is anticipated to remain stable for the duration of the study: i. Short-acting beta-agonist (SABA) only. ii. Daily maintenance low-dose inhaled corticosteroids (ICS) (defined as 100-250 μg/day fluticasone propionate or equivalent plus or minus SABA which is anticipated to remain stable for the duration of the study.
Key exclusion criteria (12 listed)
- Medical Conditions
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer.
- Participants who are currently or in the last 15 days have worked nightshifts.
- Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >21 units for males or >14 units for females.
- A positive test result for drugs of abuse (including tetrahydrocannabinol) at screening or Day -1.
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-152aA single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals. | Drug | Part 1, Part 2 |
| Salbutamol HFA-134aA single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals. | Drug | Part 1, Part 2 |
| PlaceboA single placebo HFA-152a suspension or placebo HFA-134a suspension dose, given as at 20 second intervals. | Drug | Part 1, Part 2 |
Primary outcome
Part 1 & Part 2: Provocative concentration of methacholine causing at least a 20% fall in FEV1 (PC20)
Time frame: Up to 11 weeks
14 secondary outcomes
Part 1 & Part 2: Peak QTc Interval
Time frame: Up to 11 weeks
Part 1 & Part 2: Peak Heart Rate (HR)
Time frame: Up to 11 weeks
Part 1 & Part 2: Minimum Serum Potassium
Time frame: Up to 11 weeks
Part 1: Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to 11 weeks
Part 1: Time to Reach Cmax (Tmax)
Time frame: Up to 11 weeks
Part 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: Up to 11 weeks
Part 1 & Part 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 11 weeks
Part 1 & Part 2: Absolute Values for 12-lead Electrocardiogram (ECG) Recording of HR
Time frame: Up to 11 weeks
Part 1 & Part 2: Absolute Values for 12-lead ECGs Recording of Intervals
Time frame: Up to 11 weeks
Part 1 & Part 2: Change from Baseline for Post-dose 12-lead ECGs Recording of HR
Time frame: Baseline and up to 11 weeks
Part 1 & Part 2: Change from Baseline for Post-dose 12-lead ECGs Recording of Intervals
Time frame: Up to 11 weeks
Part 1 & Part 2: Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
Time frame: Up to 11 weeks
Part 1 & Part 2: Absolute Values of Vital Signs (Systolic and Diastolic Blood Pressure)
Time frame: Up to 11 weeks
Part 1 & Part 2: Absolute Values of Vital Signs (Pulse Rate)
Time frame: Up to 11 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 42309649Moreira S, Clow L, Coles-Piper E, Donald A, Janson C, Singh D, Slade D, Tiwari P, Weng S, Plank M. Developing low-carbon salbutamol MDI: assessment of relative bioavailability and pharmacodynamic relative potency of salbutamol MDI with propellant HFA-152a. BMJ Open Respir Res. 2026 Jun 17;13(1):e004036. doi: 10.1136/bmjresp-2025-004036.
- 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.
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 Mild Asthma, run by GlaxoSmithKline at 1 site in United Kingdom.
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 11 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 6 Nov 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 & Part 2: Provocative concentration of methacholine causing at least a 20% fall in FEV1 (PC20) (time frame: Up to 11 weeks). 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 NCT06433921, which also lists 1 linked publication.
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 6 Nov 2026.