AsthmaPhase 1NCT06702462
A Study to Assess the Potential for Airway Sensitivity Reactions With Propellants HFA-152a (Test) and HFA-134a (Reference) Administered Via Pressurized Inhalers in Adults With Mild Asthma
A Phase 1 study testing HFA-152A propellant and HFA-134A propellant in people with Asthma, run by GlaxoSmithKline at 3 sites in United States.
Trial summary
The purpose of the study is to assess the propellants,1 - Difluoroethane [HFA-152a] (Test) and 1,1,1,2-Tetrafluoroethane [HFA-134a] (Reference) for their potential to cause the airways to tighten when delivered through pressurized metered dose inhalers (pMDI). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Asthma
- What is being tested?
- HFA-152A propellant and HFA-134A propellant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Mar 2025to 4 Jun 2025
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants are eligible to be included in the study if all the following criteria apply:
- Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- Participant must be 18 to 45 years of age inclusive, at the time of screening.
- Confirmed diagnosis of asthma: documented, established diagnosis of asthma for at least 6 months.
- Receiving 1 of the 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:
- As needed short-acting beta-agonists (SABA) only
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- As needed SABA plus low-dose Inhaled corticosteroids (ICS) (defined as 100-250 µg/day fluticasone propionate or equivalent taken whenever SABA is taken).
- Daily maintenance low-dose ICS, plus as needed SABA or ICS-SABA single inhaler combination therapy
- Low dose combination single inhaler ICS-formoterol or single inhaler ICS-SABA as needed for symptom relief (and if needed, before exercise)
- Leukotriene receptor antagonist (LTRAs) in combination with any of the above therapies
- Asthma Control Questionnaire (ACQ)-6 score <1.5 at screening and Day -1.
- No severe asthma exacerbations within 6 months prior to screening and ≤1 severe exacerbation during the 12 months prior to screening.
- Lung function: subjects with a pre-bronchodilator FEV1 ≥60% predicted at Screening and Day-1.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- Is a Woman of non-childbearing potential (WONCBP) OR
- Is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%.
- Female participants must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 28 days before the first dose of study intervention.
- For male participants, no contraceptive measures are required.
- Non-smokers, or previous smokers who have not used any tobacco containing-products or vaping products within 12 months prior to study start, and with a total pack year history of ≤10 pack years.
- The use of marijuana, even with a valid prescription, is prohibited within 12 months prior to study start.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and protocol.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.
- Asthma treatment requiring use of biologic agents (e.g. mepolizumab or dupilumab), chronic systemic corticosteroids, or oral controller agents other than LTRAs.
- Respiratory disorders other than asthma; 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 and other respiratory abnormalities other than asthma 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 and/or requires additional therapy during the study. This includes history of lung cancer and previous thoracic surgery such as lung resection.
- Asthma Exacerbation: Any severe asthma exacerbation within 6 months prior to screening. (Severe asthma exacerbation defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days, or a single depo injection or an in-patient hospitalization or early discontinuation (ED) visit due to asthma that required systemic corticosteroids).
- Biologic/immunosuppressive therapies that can be used for the treatment of respiratory diseases during the 6 months, or 5 half-lives whichever is longer-prior to start of the study.
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- Participants undergoing de-sensitization therapy.
- Administration of systemic, oral, or depot corticosteroids for asthma treatment within 12 weeks of Visit 1. Intranasal corticosteroids are permitted if at a stable dose for at least 3 months prior to screening.
- Stable doses (3 months or longer) of the following are permitted:
- Intranasal corticosteroids
- Oral anti-histamines
Trial locations and contacts
3 sites in 1 country.
United States3 sites
GSK Investigational Site
Huntersville, North Carolina, 28078
GSK Investigational Site
Marlton, New Jersey, 08053
GSK Investigational Site
San Antonio, Texas, 78209
About this study
Official title: A Randomized, Non-inferiority, Double-blind, Controlled, Single-dose, 2-way Cross-over Study to Assess the Potential for Airway Sensitivity Reactions With Propellants HFA-152a (Test) and HFA-134a (Reference) Administered Via Pressurized Metered Dose Inhalers in Adults Aged 18-45 With Mild Asthma
The purpose of the study is to assess the propellants,1 - Difluoroethane [HFA-152a] (Test) and 1,1,1,2-Tetrafluoroethane [HFA-134a] (Reference) for their potential to cause the airways to tighten when delivered through pressurized metered dose inhalers (pMDI). The rationale for this study is to develop a low carbon footprint alternative propellant, HFA-152a, which will have a lower impact on global warming.
- Conditions
- Asthma
- Being tested
- HFA-152A propellant, HFA-134A propellant
- Keywords
- Asthma, HFA-152a, HFA-134a, pMDI
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFA-152A propellantDrug
HFA-152A propellant is administered via oral inhalation
HFA-134A propellantDrug
HFA-134A propellant is administered via oral inhalation
| Study group | Role | What they receive |
|---|---|---|
| HFA-152A propellant followed by HFA-134A propellant | Experimental | Not described Receives: Drug: HFA-152A propellant; Drug: HFA-134A propellant |
| HFA-134A propellant followed by HFA-152A propellant | Experimental | Not described Receives: Drug: HFA-152A propellant; Drug: HFA-134A propellant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 15 Minutes Post-dose
FEV1 is defined as the volume of air that can be forced out in one second, after taking a deep breath and measured using spirometry. Baseline is defined as the latest pre-dose assessment with a non-missing value including those from unscheduled visits.
Measured: Baseline (Day 1, pre-dose) and at 15 minutes post-dose
Secondary outcomes (4)
Area Under the Curve for FEV1 From Time Zero to 15 Minutes (FEV1 AUC0-15 Mins)
FEV1 was measured using spirometry. AUC was assessed from the first non-missing timepoint to the 15 minute time point.
Measured: Up to 15 minutes post-dose
Percentage Change From Baseline in FEV1 at 5, 60, and 180 Minutes Post-dose
FEV1 is defined as the volume of air that can be forced out in one second, after taking a deep breath and measured using spirometry. Baseline is defined as the latest pre-dose assessment with a non-missing value including those from unscheduled visits.
Measured: Baseline (Day 1, pre-dose) and at 5, 60, and 180 minutes post-dose
Number of Participants With Percentage Change From Baseline in FEV1 <-15% at Timepoints 5, 15, 60 and 180 Minutes Post-dose
FEV1 is defined as the volume of air that can be forced out in one second, after taking a deep breath and using spirometry. Baseline is defined as the latest pre-dose assessment with a non-missing value including those from unscheduled visits.
Measured: Baseline (Day 1, pre-dose) and at 5, 15, 60 and 180 minutes post-dose
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
An AE is defined as any untoward medical occurrence in a clinical study participant that was temporally associated with the use of a study intervention, regardless of whether it was related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability or incapacity, or was a congenital anomaly, birth defect, or abnormal pregnancy outcome. SAEs are a subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Measured: Up to approximately 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start11 Mar 2025
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702462
- Sponsor's protocol ID
- 223166
- Status last verified
- Jun 2026
- First submitted
- 20 Nov 2024
- Last updated
- 21 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Non-inferiority, Double-blind, Controlled, Single-dose, 2-way Cross-over Study to Assess the Potential for Airway Sensitivity Reactions With Propellants HFA-152a (Test) and HFA-134a (Reference) Administered Via Pressurized Metered Dose Inhalers in Adults Aged 18-45 With Mild Asthma
- ClinicalTrials.gov ID
- NCT06702462
- Acronym / sponsor ID
- 223166
- Conditions
- Asthma
- Keywords
- Asthma, HFA-152a, HFA-134a, pMDI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 25 Nov 2024 (actual)
- Results
- Posted 21 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the propellants,1 - Difluoroethane [HFA-152a] (Test) and 1,1,1,2-Tetrafluoroethane [HFA-134a] (Reference) for their potential to cause the airways to tighten when delivered through pressurized metered dose inhalers (pMDI). The rationale for this study is to develop a low carbon footprint alternative propellant, HFA-152a, which will have a lower impact on global warming.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFA-152A propellant followed by HFA-134A propellant | Experimental | Drug: HFA-152A propellant, Drug: HFA-134A propellant |
| HFA-134A propellant followed by HFA-152A propellant | Experimental | Drug: HFA-152A propellant, Drug: HFA-134A propellant |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Participants are eligible to be included in the study if all the following criteria apply:
- Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- Participant must be 18 to 45 years of age inclusive, at the time of screening.
- Confirmed diagnosis of asthma: documented, established diagnosis of asthma for at least 6 months.
- Receiving 1 of the 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:
Key exclusion criteria (11 listed)
- A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.
- Asthma treatment requiring use of biologic agents (e.g. mepolizumab or dupilumab), chronic systemic corticosteroids, or oral controller agents other than LTRAs.
- Respiratory disorders other than asthma; 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 and other respiratory abnormalities other than asthma 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 and/or requires additional therapy during the study. This includes history of lung cancer and previous thoracic surgery such as lung resection.
- Asthma Exacerbation: Any severe asthma exacerbation within 6 months prior to screening. (Severe asthma exacerbation defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days, or a single depo injection or an in-patient hospitalization or early discontinuation (ED) visit due to asthma that required systemic corticosteroids).
- Biologic/immunosuppressive therapies that can be used for the treatment of respiratory diseases during the 6 months, or 5 half-lives whichever is longer-prior to start of the study.
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 |
|---|---|---|
| HFA-152A propellantHFA-152A propellant is administered via oral inhalation | Drug | HFA-134A propellant followed by HFA-152A propellant, HFA-152A propellant followed by HFA-134A propellant |
| HFA-134A propellantHFA-134A propellant is administered via oral inhalation | Drug | HFA-134A propellant followed by HFA-152A propellant, HFA-152A propellant followed by HFA-134A propellant |
Primary outcome
Percentage Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 15 Minutes Post-dose
Time frame: Baseline (Day 1, pre-dose) and at 15 minutes post-dose
FEV1 is defined as the volume of air that can be forced out in one second, after taking a deep breath and measured using spirometry. Baseline is defined as the latest pre-dose assessment with a non-missing value including those from unscheduled visits.
4 secondary outcomes
Area Under the Curve for FEV1 From Time Zero to 15 Minutes (FEV1 AUC0-15 Mins)
Time frame: Up to 15 minutes post-dose
Percentage Change From Baseline in FEV1 at 5, 60, and 180 Minutes Post-dose
Time frame: Baseline (Day 1, pre-dose) and at 5, 60, and 180 minutes post-dose
Number of Participants With Percentage Change From Baseline in FEV1 <-15% at Timepoints 5, 15, 60 and 180 Minutes Post-dose
Time frame: Baseline (Day 1, pre-dose) and at 5, 15, 60 and 180 minutes post-dose
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: Up to approximately 85 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HFA-152A propellant and HFA-134A propellant in people with Asthma, run by GlaxoSmithKline at 3 sites in United States.
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 21 inclusion and 11 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 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 21 Aug 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?
Percentage Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 15 Minutes Post-dose (time frame: Baseline (Day 1, pre-dose) and at 15 minutes post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.