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CompletedNCT05363670Updated Jul 14, 2026Results posted

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

A Phase 2 interventional study of ARS-1 1 mg and Albuterol MDI in Asthma, sponsored by ARS Pharmaceuticals, Inc.. Completed at 4 sites in United States. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by ARS Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
12 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Asthma

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03

Who can participate

Ages eligible
12 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Active comparator
    Sequence 1

    ARS 2mg: albuterol: Placebo: ARS 1mg

    Drug: ARS-1 1 mg · Drug: Albuterol MDI · Drug: Placebo · Drug: ARS-1 2mg

  • Active comparator
    Sequence 2

    ARS 1mg: Placebo: albuterol: ARS 2mg

    Drug: ARS-1 1 mg · Drug: Albuterol MDI · Drug: Placebo · Drug: ARS-1 2mg

Interventions

  • DrugARS-1 1 mg

    ARS-1 1 mg

  • DrugAlbuterol MDI

    180 mcg

  • DrugPlacebo

    Placebo

  • DrugARS-1 2mg

    ARS-1 2mg

05

What researchers measure

Primary outcomes

  1. Effect of ARS-1 Versus Albuterol and Placebo

    Difference in forced expiratory volume in 1 second (FEV1) based on area under the curve (AUC)

    Time frame: From baseline (timepoints 0) to 1 hour

06

Results

Posted Jul 14, 2026

Participant flow

Participant flow — Overall Study
MilestoneSequence 1Sequence 2
Started126
Completed126
Not completed00

Outcome measures

PrimaryEffect of ARS-1 Versus Albuterol and Placebo

Difference in forced expiratory volume in 1 second (FEV1) based on area under the curve (AUC)

Time frame:
From baseline (timepoints 0) to 1 hour
Reported as:
Mean · FEV1 L per hour
Effect of ARS-1 Versus Albuterol and Placebo
FEV1 L per hourARS-1 1mgARS-1 2mgPlaceboAlbuterol
Effect of ARS-1 Versus Albuterol and Placebo0.150 ± 0.2230.233 ± 0.216-0.002 ± 0.1180.378 ± 0.265

Adverse events

Collected over 5 hours. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ARS-1 1mg0/18 (0%)0/18 (0%)5/18 (27.8%)
ARS-1 2mg0/18 (0%)0/18 (0%)7/18 (38.9%)
Placebo0/18 (0%)0/18 (0%)1/18 (5.6%)
Albuterol0/18 (0%)0/18 (0%)0/18 (0%)
Most frequent other events
Most frequent other events
EventARS-1 1mgARS-1 2mgPlaceboAlbuterol
Nasal discomfortGeneral disorders5/187/181/180/18

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Interventional Treatment
<=18 years0
Between 18 and 65 years18
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Interventional Treatment
Female9
Male9
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Interventional Treatment
Region of Enrollment
Region of Enrollment(participants)Interventional Treatment
United States18
07

Study locations

4 sites
  • University of South Florida
    Tampa, Florida 33613, United States
  • Institute for Asthma and Allergy
    Chevy Chase, Maryland 20815, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Bernstein Clinical Research Center, LLC
    Cincinnati, Ohio 45236, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 6, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT05363670
Lead sponsor
ARS Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
May 6, 2022
Start date
Jul 28, 2022
Primary completion
Feb 2, 2024
Completion
Feb 2, 2024
Results posted
Jul 14, 2026
Last update
Jul 14, 2026

Study contacts

Sarina Tanimoto, MD, PhD
study director · ARS Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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