RecruitingPhase 3

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares the safety of two gases, HFA-152a and HFA-134a, used to push medicine out of inhalers over 4 weeks. It is for adults with stable asthma.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old and able to sign a consent form and follow study rules.
  • Have a documented history of asthma for at least 6 months.
  • Have used an allowed asthma treatment plan for at least 12 weeks, with no changes expected during the study.
  • Have a breathing test result of at least 50% of the expected value before using medicine that opens the airways.
  • Have an asthma control score below 1.5 at screening and treatment assignment, with no severe asthma flare-ups in the last 3 months.
  • Have used no inhaled tobacco, vaping products, or inhaled marijuana in the past 12 months. Have smoked no more than 10 pack-years total—for example, 1 pack a day for 10 years.
  • Be able to use the study's spray inhaler correctly and consistently.
  • Not be pregnant or breastfeeding. If able to become pregnant, use highly effective birth control from 30 days before treatment until at least 24 hours after the last dose, and have a negative pregnancy test before each treatment period.

Who can't join

  • A history of life-threatening asthma, another serious lung disease, or a severe asthma flare-up in the past 3 months needing steroid treatment for at least 3 days, an overnight hospital stay, or emergency care with added asthma treatment.
  • A breathing tract, sinus, or middle ear infection that has not cleared within 4 weeks of screening.
  • An uncontrolled illness that could make the study unsafe or affect results, or a known or suspected history of alcohol or drug abuse.
  • Use of a cholinesterase inhibitor, such as medicine for myasthenia gravis, or other medicines that strongly affect asthma or interact with certain airway-opening drugs. Allergy or suspected sensitivity to salbutamol inhaler ingredients.
  • Exposure to more than 4 new study chemicals in the past 12 months, or another clinical study within 30 days of study start—or longer if that study drug stays in the body longer.
  • Planned changes in asthma medicines, or changes in work, travel, or surroundings that could increase contact with allergy triggers.
  • A significant abnormal heart tracing, including a QTc above 480 milliseconds—a sign that the heart takes too long to reset between beats.
  • Liver scarring or unstable liver or bile duct disease. ALT, a liver blood test, above twice normal, or bilirubin above 1.5 times normal, with a specific exception for Gilbert's syndrome.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 use of inhaled marijuana, even with a valid prescription, is prohibited within 12 months prior to study start. * 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 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. * Adults capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF). Exclusion Criteria: * 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 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 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 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 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. * 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).

Study sites (12)

FL

KY

MO

NV

OR

SC

TX