Eco-Friendly inhaler on the horizon? new study checks if it works the same

NCT ID NCT06139991

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a new, more environmentally friendly propellant (HFO) in a budesonide/albuterol inhaler delivers the same amount of medicine into the bloodstream as the current version (HFA). Sixty-six healthy adults received single doses of both inhalers in a random order. The goal was to see if the drug levels were similar enough to consider the two versions equivalent.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
budesonide and albuterol (inhaler with a new propellant)
What this could lead to
If successful, this could confirm that the new propellant version of the inhaler works the same as the current one, potentially leading to a more environmentally friendly option.
What could go wrong
This is a very early, small study in healthy people, not patients. It only checks drug levels in the blood, not whether the inhaler actually treats asthma or COPD. The new propellant might still behave differently in real-world use.

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

66 people

The number who actually took part.

Started

Nov 2023

Finished

May 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

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Healthy male and female participants (of non-childbearing potential) aged 18 to 60 years, inclusive, with suitable veins for cannulation or repeated venipuncture. * Female participants must have a negative pregnancy test at screening and on admission and must not be lactating. * Participants with Body mass index between 18 and 30 kg/m\^2, inclusive, and weighing between 50 kg and no more than 120 kg inclusive. * Participants must have a Forced expiratory volume (FEV)1 ≥ 80% of the predicted normal value and an FEV1/FVC\> 70% regarding age, height, and ethnicity at the screening visit. * Participants must demonstrate proper inhalation technique and is able to use an MDI properly after training. Exclusion Criteria: * History or presence of gastrointestinal, hepatic or renal disease, or any other clinically significant disease or disorder. * History of any clinically significant disease or disorder which may either put the participant at risk because of participation in the study or influence the results or the participant's ability to participate in the study. * Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study drug. * Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results at the screening. * Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, or Human immunodeficiency virus (HIV). * Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG. * Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening. * Known or suspected history of alcohol or drug abuse. * Positive screen for drugs of abuse, alcohol, or cotinine at screening. * History or presence of severe allergy/hypersensitivity. * Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of the study drug. * Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, mega dose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks or 5 half-lives of the medication, whichever is longer, prior to the first administration of study drug. * Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening. * Excessive intake of caffeine-containing drinks or food. * Vulnerable participants.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Research Site

    Glendale, California, 91206, United States

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