Asthma study: HFA-152a vs HFA-134a
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)
ClinicalTrials.gov ID: NCT07645248
What this study is testing
What is HFA-152a?
an investigational propellant component being studied for use in asthma inhalers
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to collect safety information by comparing inhalers that use HFA‑152a with those that use the usual HFA‑134a propellant.
- Who it's for
- Adults who have asthma.
- What's involved
- Participants will use a metered‑dose inhaler containing either the test propellant (HFA‑152a) or the reference propellant (HFA‑134a) for about four weeks and will have safety checks and tests.
- Time commitment
- The trial lasts roughly four weeks with regular clinic visits for safety assessments.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant must be aged greater than equal to (\>=)18 years at the time of signing the informed consent.
- Documented history of asthma, as defined by Global Initiative for Asthma (GINA)
- Short-Acting beta2-Adrenoreceptor Agonists (SABA) as needed (prn) only
- Inhaled corticosteroid (ICS)/SABA prn only
- SABA prn plus ICS prn
You likely can't join if
- Participants with a history of life-threatening asthma.
- Participants with other significant pulmonary diseases, including (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary...
- Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that...
- Participants with severe asthma exacerbation: Defined as any asthma exacerbation requiring \>=3 days systemic corticosteroids or that resulted in...
- Participants with Other concurrent Diseases/Abnormalities: A participant has any clinically significant, uncontrolled condition or disease state...
- Participants with current use of cholinesterase inhibitor medication (e.g. for myasthenia gravis).
See the full eligibility criteria
- Participant must be aged greater than equal to (\>=)18 years at the time of signing the informed consent.
- Documented history of asthma, as defined by Global Initiative for Asthma (GINA)
- 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).
- Baseline pre-bronchodilator Forced expiratory volume in 1 second (FEV1) \>=50 percent (%) of predicted at screening.
- Asthma Control Status
- Asthma Control Questionnaire (ACQ)-6 score less than (\<) 1.5 at screening (and randomization).
- Asthma that has remained stable with no severe exacerbations within the last 3 months.
- 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.
- Participants who demonstrate ability to use pressurized MDI device in a satisfactory and repeatable manner, as judged visually by the investigator or designee.
- Is a Participant of nonchildbearing potential (PONCBP) or
- 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...
- Adults capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF).
- 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...
- 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 screening.
- 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...
- 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...
- 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 Drug or Excipient Allergy: Known or suspected sensitivity to the constituents of salbutamol MDI (e.g. HFA-134a, Oleic acid etc.).
- 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...
- Participants with a known or suspected history of alcohol or drug abuse.
- Any planned or anticipated changes in asthma medications during the study period.
- Any planned environmental changes (e.g. employment changes, travel) which, in the Investigator's opinion, could lead to e.g. increased allergen exposure.
- 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).
The study team makes the final eligibility decision.
Where it is enrolling
- Aventura, Florida, United States
- Miami, Florida, United States
- Naples, Florida, United States
- Owensboro, Kentucky, United States
- Columbia, Missouri, United States
- Henderson, Nevada, United States
- Medford, Oregon, United States
- Spartanburg, South Carolina, United States
- Cypress, Texas, United States
- Tomball, Texas, United States
- Buenos Aires, Argentina
- Ciudad Autonoma de Buenos Aire, Argentina
- Lujan de Cuyo, Argentina
- Ajax, Ontario, Canada
- Québec, Quebec, Canada
- Trois-Rivières, Quebec, Canada
- Great Cambourne, Cambridge, United Kingdom
- Greater Manchester, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aventura, Florida, United States; Miami, Florida, United States; Naples, Florida, United States; Owensboro, Kentucky, United States; Columbia, Missouri, United States; Henderson, Nevada, United States and 12 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.