Trial comparing treatments 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)
ClinicalTrials.gov ID: NCT07645248
What this study is testing
What is HFA-152a?
HFA-152a is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for asthma.
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
- 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).
- 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.
- 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 visit and which is anticipated to remain stable for the...
- Short-Acting beta2-Adrenoreceptor Agonists (SABA) as needed (prn) only
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.
- 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 visit 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:
- 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. The...
- Participants who demonstrate ability to use pressurized MDI device in a satisfactory and repeatable manner, as judged visually by the investigator or designee.
- Male and female participants are eligible. 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 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's taking place
- Aventura, Florida, United States
- Miami, 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
- Québec, Quebec, Canada
- Great Cambourne, Cambridge, United Kingdom
- Greater Manchester, United Kingdom
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include Aventura, Florida, United States; Miami, Florida, United States; Owensboro, Kentucky, United States; Columbia, Missouri, United States; Henderson, Nevada, United States; Medford, Oregon, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.