ClinicalTrials.gg
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

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

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,694 studies in Asthma with a site in United States — 134 open to participants now, 187 under way, 19 of them phase 3. Asthma · United States.

Enrollment
1,162nd of 1,353
18 · median 100
Started
2022
with 43 others
Phase 2
292 of 1,694
22 open now
Registered
1,486th of 1,694
by date

Among the 1,694 studies in Asthma with a site in United States, this one is the 1,162nd largest by enrollment of the 1,353 interventional ones that give a count, is one of 44 that started in 2022, is one of 292 in phase 2, and was the 1,486th registered.

Asthma

4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.

Browse Asthma studies →

Open to participants now

134 of the 1,694 studies in Asthma with a site in United States are open now. Recruiting first, the newest first:

129 more — sign in →

All 134 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 147 take children under 18; 105 take healthy volunteers.

This study: 12 Years to 65 Years · all sexes · no healthy volunteers.

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02

Study summary

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

03

Conditions studied

  • Asthma

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04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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 .
  • 5. Has mucosal inflammatory disorders.
  • 6. Has had significant traumatic injury, major surgery or open within 30 days prior to study screening.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

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

06

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

07

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
08

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
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2022 to primary completion in Feb 2024, 18 months.

Results were first posted in Jul 2026, 2 years 5 months after primary completion.

Of 137 industry-sponsored phase 2 interventional studies under Asthma, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 23. This study's 18 months is above that.

Counting every sponsor, half of 199 studies reached it within 20 months; a quarter within 12 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2022
First posted
May 6, 2022
StartActual
Jul 28, 2022
Primary completionActual
Feb 2, 2024
CompletionActual
Feb 2, 2024
Results first posted
Jul 14, 2026
Last update
Jul 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

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 ↗

Not currently enrolling

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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Discussion

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