Comparing HFA-152a with HFA-134a for asthma
Official title: A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
A Randomized, Double-blind, 2-way Crossover, Multicenter Study to Evaluate the Safety of Test Propellant HFA-152a and Reference Propellant HFA-134a When Administered Via Metered Dose Inhalers
- Phase 3
- 2 groups
- Sites in Ajax, Québec and 1 more city
- Recruiting
Interventions
- Medication
HFA-152a
HFA-152a will be administered.
- Medication
HFA-134a
HFA-134a will be administered.
Canadian Sites (3)
3 of 3 recruiting
- Recruiting
GSK Investigational Site
Ajax, Ontario
- Recruiting
GSK Investigational Site
Québec, Quebec
- Recruiting
GSK Investigational Site
Trois-Rivières, Quebec
Eligibility Criteria
See who this study is looking for46 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participant must be aged greater than equal to (\>=)18 years at the time of signing the informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Participants with asthma for \>= 6 months, defined as:
- +Documented history of asthma, as defined by Global Initiative for Asthma (GINA)
- +Receiving one of following asthma treatments for at least 12 weeks prior to the screening visitScreeningThe checks done before joining, to see whether a study fits.Read more → and which is anticipated to remain stable for the duration of the study:
- +Short-Acting beta2-Adrenoreceptor Agonists (SABA) as needed (prn) only
- +Inhaled corticosteroid (ICS)/SABA prn only
- +SABA prn plus ICS prn
- +SABA prn plus ICS maintenance
- +ICS/SABA prn plus ICS maintenance
- +SABA prn plus ICS/ Long-acting beta agonist (LABA) maintenance
- +ICS/SABA prn plus ICS/LABA maintenance
- +SABA prn plus ICS/ Long-acting muscarinic antagonist (LAMA)/LABA maintenance (open or closed triple therapy)
- +ICS/Formoterol combination therapy as reliever therapy
- +ICS/Formoterol combination therapy as maintenance therapy plus ICS/Formoterol combination as reliever therapy.
- +Leukotriene receptor antagonist (LTRA) as add-on any of the above is permitted
- +Xanthines as add-on to any of the above permitted
- +Biological therapies indicated for the treatment of asthma as add-on to any of the above are permitted (for example, but not limited to, mepolizumab, dupilumab, tezepelumab).
- +Participants with severity of disease:
- +BaselineBaselineYour starting measurements, taken before treatment begins.Read more → pre-bronchodilator Forced expiratory volume in 1 second (FEV1) \>=50 percent (%) of predicted at screening.
- +Asthma ControlControl groupThe group a new treatment is measured against.Read more → Status
- +Asthma Control Questionnaire (ACQ)-6 score less than (\<) 1.5 at screening (and randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →).
- +Asthma that has remained stable with no severe exacerbations within the last 3 months.
- +Participants who demonstrate ability to use pressurized MDI device in a satisfactory and repeatable manner, as judged visually by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → or designee.
- +Male and female participants are eligible.
- +Is a Participant of nonchildbearing potential (PONCBP) or
- +Adults capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF).
- +A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:
- +Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of \<1%, 30 days prior to and during the study intervention period and for at least 24 hours after the last dose of study intervention. - A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention in each Treatment Period.
- +Participants who are current non-smokers, who have not used any inhaled tobacco or vaping products within 12 months of the start of the study, and with a total pack year history of less than equal to (\<=)10 pack. The use of inhaled marijuana, even with a valid prescription, is prohibited within 12 months prior to study start.
Exclusion
- −Participants with Drug or Excipient Allergy: Known or suspected sensitivity to the constituents of salbutamol MDI (e.g. HFA-134a, Oleic acid etc.).
- −Any planned environmental changes (e.g. employment changes, travel) which, in the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion, could lead to e.g. increased allergen exposure.
- −Participants with a history of life-threatening asthma.
- −Participants with other significant pulmonary diseases, including (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other significant respiratory abnormalities other than asthma.
- −Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −Participants with severe asthma exacerbation: Defined as any asthma exacerbation requiring \>=3 days systemic corticosteroids or that resulted in overnight hospitalization or Emergency Department visit requiring additional treatment for asthma within the 3 months prior to screening.
- −Participants with Other concurrent Diseases/Abnormalities: A participant has any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the participant at risk through study participation or would confound the interpretation of the study results.
- −Participants with current use of cholinesterase inhibitor medication (e.g. for myasthenia gravis).
- −Participants with any other prescription or over the counter medication which would significantly affect the course of asthma, or that could interact with sympathomimetic amines.
- −Participants with exposure to more than four 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 with a known or suspected history of alcohol or drug abuse.
- −Any planned or anticipated changes in asthma medications during the study period.
- −12-Lead ECG abnormality: Significant abnormality in the 12-lead ECG performed at screening.
- −Alanine transaminase (ALT) \>2 times Upper limit of normal (ULN).
- −Total bilirubin \>1.5 times ULN; For participants with Gilbert's syndrome can be included with total bilirubin \>1.5 times ULN if direct bilirubin is \<=1.5 times ULN.
- −Participants with Cirrhosis or current unstable liver or biliary disease.
- −Participants with QTc \>480 milliseconds (msec).
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives HFA-152a and HFA-134a.
Registry label: A: Participants receiving HFA-152a followed by HFA-134a
Group B receives HFA-134a and HFA-152a.
Registry label: B: Participants receiving HFA-134a followed by HFA-152a
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 110 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: Up to 8 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Number of participants with adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) — measured over Up to 8 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07645248 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About HFA-152aDrug
HFA-152a will be administered.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About HFA-134aDrug
HFA-134a will be administered.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 8 weeks.
The study as a whole is currently expected to finish around 2026-12-28.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 110 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 3 locations, including: Ajax, Ontario, Canada; Québec, Quebec, Canada; Trois-Rivières, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study aims to generate additional safety data on the propellant component of the reformulated product by comparing metered dose inhaler (MDIs) containing HFA-152a (test) with HFA-134a (reference).
If this study interests you
Three things you can do from here. None of them commits you to anything.
Save it to your Collection
Keep it with the other studies you are looking at.
Share it with your doctor
Send the study to your own clinician to talk through together.
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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.