New inhaler propellant put to the test in healthy volunteers
NCT ID NCT06506266
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed phase 1 study in 24 healthy adults compared a new inhaler propellant (HFA-152a) to a standard one (HFA-134a) to see if it affects how the lungs clear mucus. Participants inhaled each propellant for several days, and lung clearance was measured using a radioactive tracer. The goal is to ensure the new propellant is safe for use in asthma inhalers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HFA-152a (a propellant used in inhalers)
- What this could lead to
- If HFA-152a is shown to be safe and not harm lung clearance, it could become a more environmentally friendly propellant for asthma inhalers.
- What could go wrong
- This is a very early, small study in healthy people, not those with asthma. It only measures lung clearance, not whether the propellant works for treating asthma. Results may not apply to patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
24 people
The number who actually took part.
- Started
-
Jul 2024
- Finished
-
Oct 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
30 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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 * 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 Exclusion Criteria: 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
GSK Investigational Site
Nottingham, NG11 6JS, United Kingdom
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