AsthmaPhase 1NCT06506266
Study of the Effect of HFA-152a and HFA-134a Propellants on Mucociliary Clearance in Healthy Participants
A Phase 1 study testing HFA-152a, HFA-134a and Radiolabeled saline solution in people with Asthma, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The main goal of the study is to assess the effect of the administration of reference propellant [HFA-134a (1,1,1,2 - Tetrafluoroethane)] and test propellant [HFA-152a (1 - Difluoroethane)] in healthy adults on mucociliary clearance (MCC). Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- HFA-152a, HFA-134a and Radiolabeled saline solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jul 2024to 24 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants are eligible to be included in the study only if all following criteria apply:
- Male or Female, age 30 to 55 years
- Body Mass Index (BMI): 18.0 to 32.0 kg/m2, inclusive, at screening
- Weight: ≥50 kg
- Nonsmokers or ex-smokers for more than 6 months with a smoking history of <10 pack years
- Status: healthy participants
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- Spirometry data.
- Forced Expiratory Volume in 1 second (FEV1) ≥80% of predicted values.
- FEV1: Forced vital capacity (FVC) ratio >70%.
- Females must be of nonchildbearing potential, and agree not to donate eggs (ova, oocytes) for the purpose of reproduction during the study intervention period and at least 30 days after the last dose of study intervention.
- Male participants are eligible to participate if they agree to:
- Refrain from donating sperm
- Either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
- Or must agree to use a male condom when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. The female partner should additionally use a highly effective contraceptive method with a failure rate of <1% per year.
- All prescribed medication must have been stopped at least 30 days prior to admission to the clinical research centre based on investigator judgment. An exception is made for Hormonal Replacement Therapy (HRT), and occasional paracetamol which may be used throughout the study.
- Capable of giving written informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Capable of using inhaler device with no physical or other issues which would impair the participant's ability to successfully use a metered dose inhaler (MDI) inhaler as instructed in this study.
- Ability to comply with the protocol. Participants have capacity and no issues which would impair their ability to comply with all aspects of the protocol during the study
Who cannot join
- Participants who meet any of the following exclusion criteria at screening will not be eligible to participate in the study:
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker shall participate in the study.
- History or presence of any form of asthma, including childhood asthma and exercise induced asthma.
- 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 (COPD), tuberculosis, known alpha 1 antitrypsin deficiency and other respiratory abnormalities other than asthma that, in the opinion of the investigator, could put the participant at risk through study participation or could affect the study analyses and data interpretation.
- Recent history of mild conditions potentially affecting Mucociliary clearance (MCC) (viral infections, cough, cold, active hay fever etc.) in the last 14 days.
- Recent use of drugs for treating conditions potentially affecting MCC (viral infections, cough, cold, etc.) in the last 30 days.
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- Vaccine(s) within 2 weeks prior to admission or plans to receive such vaccines during the study.
- Current enrolment or past participation in this clinical study.
- Positive human immunodeficiency virus (HIV) antibody test.
- Regular use of known drugs of abuse, including Tetrahydrocannabinol (THC).
- Average intake of more than 21 units of alcohol per week in males and 14 units per week in females (clinical site standard: unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits) based on breath alcohol test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Single-site, Two-way Crossover Phase 1 Study to Assess the Effect of Repeated Doses of Test Propellant (HFA-152a) on Mucociliary Clearance as Compared to Reference Propellant (HFA-134a) in Healthy Male and Female Participants
The main goal of the study is to assess the effect of the administration of reference propellant [HFA-134a (1,1,1,2 - Tetrafluoroethane)] and test propellant [HFA-152a (1 - Difluoroethane)] in healthy adults on mucociliary clearance (MCC).
- Conditions
- Asthma
- Being tested
- HFA-152a, HFA-134a, Radiolabeled saline solution
- Keywords
- HFA-152a, HFA-134a, Crossover, MCC
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFA-152aOther
HFA-152a is administered via oral inhalation
HFA-134aOther
HFA-134a is administered via oral inhalation
Radiolabeled saline solutionOther
Radiolabeled saline solution is administered via oral inhalation
| Study group | Role | What they receive |
|---|---|---|
| HFA-152a followed by HFA-134a | Experimental | Not described Receives: Other: HFA-152a; Other: HFA-134a; Other: Radiolabeled saline solution |
| HFA-134a followed by HFA-152a | Experimental | Not described Receives: Other: HFA-152a; Other: HFA-134a; Other: Radiolabeled saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Percent Radiolabeled Particle Retention-time Curve up to 4 Hours [AUC(0-4h)] After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7
[AUC(0-4h)] was assessed for Mucociliary clearance (MCC) in participants following administration of nebulized 99mTc on Day 7. Gamma scintigraphy was utilized to conduct assessments.
Measured: At 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 minutes on Day 7
Secondary outcomes (4)
Percentage of Radiolabeled Particle Retention at 1 Hour After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7
Gamma scintigraphy was utilized to conduct assessments.
Measured: 1 hour after inhalation on Day 7
Percentage of Radiolabeled Particle Retention at 1.5 Hours After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7
Gamma scintigraphy was utilized to conduct assessments.
Measured: 1.5 hours after inhalation on Day 7
Percentage of Radiolabeled Particle Retention at 3 Hours After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7
Gamma scintigraphy was utilized to conduct assessments.
Measured: 3 hours after inhalation on Day 7
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, 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. The AE data presented below is of frequency threshold - 0%.
Measured: Up to approximately 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start29 Jul 2024
- Primary completion24 Oct 2024
- Study completion24 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506266
- Sponsor's protocol ID
- 221781
- Status last verified
- Mar 2026
- First submitted
- 11 Jul 2024
- Last updated
- 14 Apr 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/
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-site, Two-way Crossover Phase 1 Study to Assess the Effect of Repeated Doses of Test Propellant (HFA-152a) on Mucociliary Clearance as Compared to Reference Propellant (HFA-134a) in Healthy Male and Female Participants
- ClinicalTrials.gov ID
- NCT06506266
- Acronym / sponsor ID
- 221781
- Conditions
- Asthma
- Keywords
- HFA-152a, HFA-134a, Crossover, MCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Posted 14 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of the study is to assess the effect of the administration of reference propellant [HFA-134a (1,1,1,2 - Tetrafluoroethane)] and test propellant [HFA-152a (1 - Difluoroethane)] in healthy adults on mucociliary clearance (MCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFA-152a followed by HFA-134a | Experimental | Other: HFA-152a, Other: HFA-134a, Other: Radiolabeled saline solution |
| HFA-134a followed by HFA-152a | Experimental | Other: HFA-152a, Other: HFA-134a, Other: Radiolabeled saline solution |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Participants are eligible to be included in the study only if all following criteria apply:
- Male or Female, age 30 to 55 years
- Body Mass Index (BMI): 18.0 to 32.0 kg/m2, inclusive, at screening
- Weight: ≥50 kg
- Nonsmokers or ex-smokers for more than 6 months with a smoking history of <10 pack years
Key exclusion criteria (11 listed)
- Participants who meet any of the following exclusion criteria at screening will not be eligible to participate in the study:
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker shall participate in the study.
- History or presence of any form of asthma, including childhood asthma and exercise induced asthma.
- 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 (COPD), tuberculosis, known alpha 1 antitrypsin deficiency and other respiratory abnormalities other than asthma that, in the opinion of the investigator, could put the participant at risk through study participation or could affect the study analyses and data interpretation.
- Recent history of mild conditions potentially affecting Mucociliary clearance (MCC) (viral infections, cough, cold, active hay fever etc.) in the last 14 days.
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-152aHFA-152a is administered via oral inhalation | Other | HFA-134a followed by HFA-152a, HFA-152a followed by HFA-134a |
| HFA-134aHFA-134a is administered via oral inhalation | Other | HFA-134a followed by HFA-152a, HFA-152a followed by HFA-134a |
| Radiolabeled saline solutionRadiolabeled saline solution is administered via oral inhalation | Other | HFA-134a followed by HFA-152a, HFA-152a followed by HFA-134a |
Primary outcome
Area Under the Percent Radiolabeled Particle Retention-time Curve up to 4 Hours [AUC(0-4h)] After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7
Time frame: At 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 minutes on Day 7
[AUC(0-4h)] was assessed for Mucociliary clearance (MCC) in participants following administration of nebulized 99mTc on Day 7. Gamma scintigraphy was utilized to conduct assessments.
4 secondary outcomes
Percentage of Radiolabeled Particle Retention at 1 Hour After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7
Time frame: 1 hour after inhalation on Day 7
Percentage of Radiolabeled Particle Retention at 1.5 Hours After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7
Time frame: 1.5 hours after inhalation on Day 7
Percentage of Radiolabeled Particle Retention at 3 Hours After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7
Time frame: 3 hours after inhalation on Day 7
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: Up to approximately 13 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 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 HFA-152a, HFA-134a and Radiolabeled saline solution in people with 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 18 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 14 Apr 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?
Yes. Results are posted in the registry (first posted 14 Apr 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?
Area Under the Percent Radiolabeled Particle Retention-time Curve up to 4 Hours [AUC(0-4h)] After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7 (time frame: At 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 minutes on Day 7). 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 14 Apr 2026.