Administration of ARS-1 or Albuterol in Subjects With Persistent Asthma

June 17, 2026 updated by: ARS Pharmaceuticals, Inc.

A Phase 2, Single-Dose, Randomized, Active and Placebo Controlled, Four-Period, Cross-Over Study of the Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 or Albuterol in Subjects With Persistent Asthma

ARS-1 is being developed for patients as a needleless alternative route of epinephrine administration for the management of refractory asthma symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33613
        • University of South Florida
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Institute for Asthma and Allergy
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Bernstein Clinical Research Center, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 61 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sequence 1
ARS 2mg: albuterol: Placebo: ARS 1mg
Drug: Placebo
Placebo
Drug: Albuterol MDI
180 mcg
Drug: ARS-1 1 mg
ARS-1 1 mg
Drug: ARS-1 2mg
ARS-1 2mg
Active Comparator: Sequence 2
ARS 1mg: Placebo: albuterol: ARS 2mg
Drug: Placebo
Placebo
Drug: Albuterol MDI
180 mcg
Drug: ARS-1 1 mg
ARS-1 1 mg
Drug: ARS-1 2mg
ARS-1 2mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of ARS-1 Versus Albuterol and Placebo
Time Frame: From baseline (timepoints 0) to 1 hour
Difference in forced expiratory volume in 1 second (FEV1) based on area under the curve (AUC)
From baseline (timepoints 0) to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARS Pharmaceuticals, Inc.

Investigators

  • Study Director: Sarina Tanimoto, MD, PhD, ARS Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2022

Primary Completion (Actual)

February 2, 2024

Study Completion (Actual)

February 2, 2024

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 6, 2022

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPI A01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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