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Asthma rescue without needles: nasal spray could replace shots

NCT ID NCT05363670

Disease control Sponsor: ARS Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This phase 2 trial tests a needle-free epinephrine nasal spray (ARS-1) for managing asthma symptoms. People with persistent asthma receive a single dose of ARS-1, albuterol, or placebo in random order. The study measures how well the spray improves lung function compared to standard treatments.

What this could mean

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

Active substance
a needle-free epinephrine nasal spray called ARS-1
What this could lead to
If successful, this could offer a needle-free way to quickly treat asthma attacks, making emergency epinephrine easier to use.
What could go wrong
This is an early phase 2 trial with only 18 participants, so results may not apply to everyone. The spray may not work as well as injected epinephrine.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

18 people

The number who actually took part.

Started

Jul 2022

Finished

Feb 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

12 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * 1\. Is a male or female subject between the ages of 12 and 65 years, inclusive. * 2\. Asthma that has been stable for at least four weeks prior to screening as defined by clinical history. * 3\. Reversible bronchoconstriction. * 4\. Has body weight more than 30 kilogram (kg) and body mass index between 18 and 34 kg/m², inclusive. * 5\. Has no medical history of hypertension and cardiovascular disease in the last 10 years. * 6\. At screening, has stable vital signs. Exclusion Criteria: * 1\. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition. * 2\. Patients receiving beta blocker. * 3\. Has any clinically significant medical condition or physical exam finding as deemed inappropriate by the Investigator. * 4\. Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram. * 5\. Has mucosal inflammatory disorders. * 6\. Has had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening.

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Conditions

The condition(s) this trial relates to.

asthma chronic asthma

As listed by the trial registrant

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

Asthma

Contacts and locations

Locations

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio, 45236, United States

  • Institute for Asthma and Allergy

    Chevy Chase, Maryland, 20815, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • University of South Florida

    Tampa, Florida, 33613, United States

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