AsthmaPhase 2NCT05363670
Administration of ARS-1 or Albuterol in Subjects With Persistent Asthma
A Phase 2 study testing ARS-1 1 mg, Albuterol MDI and ARS-1 2mg in people with Asthma, run by ARS Pharmaceuticals, Inc. at 4 sites in United States.
Trial summary
ARS-1 is being developed for patients as a needleless alternative route of epinephrine administration for the management of refractory asthma symptoms. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- ARS-1 1 mg, Albuterol MDI and ARS-1 2mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Jul 2022to 2 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Institute for Asthma and Allergy
Chevy Chase, Maryland, 20815
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45236
University of South Florida
Tampa, Florida, 33613
About this study
Official title: 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.
- Conditions
- Asthma
- Being tested
- ARS-1 1 mg, Albuterol MDI, Placebo, ARS-1 2mg
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARS-1 1 mgDrug
ARS-1 1 mg
Albuterol MDIDrug
180 mcg
PlaceboDrug
Placebo
ARS-1 2mgDrug
ARS-1 2mg
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Active comparator | ARS 2mg: albuterol: Placebo: ARS 1mg Receives: Drug: ARS-1 1 mg; Drug: Albuterol MDI; Drug: Placebo; Drug: ARS-1 2mg |
| Sequence 2 | Active comparator | ARS 1mg: Placebo: albuterol: ARS 2mg Receives: Drug: ARS-1 1 mg; Drug: Albuterol MDI; Drug: Placebo; Drug: ARS-1 2mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of ARS-1 Versus Albuterol and Placebo
Difference in forced expiratory volume in 1 second (FEV1) based on area under the curve (AUC)
Measured: From baseline (timepoints 0) to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start28 Jul 2022
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARS Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarina Tanimoto, MD, PhD, Study director, ARS Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363670
- Sponsor's protocol ID
- EPI A01
- Status last verified
- Jun 2026
- First submitted
- 27 Apr 2022
- Last updated
- 14 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05363670
- Acronym / sponsor ID
- EPI A01
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- ARS Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 6 May 2022 (actual)
- Results
- Posted 14 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ARS-1 is being developed for patients as a needleless alternative route of epinephrine administration for the management of refractory asthma symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Active comparator | Drug: ARS-1 1 mg, Drug: Albuterol MDI, Drug: Placebo, Drug: ARS-1 2mgARS 2mg: albuterol: Placebo: ARS 1mg |
| Sequence 2 | Active comparator | Drug: ARS-1 1 mg, Drug: Albuterol MDI, Drug: Placebo, Drug: ARS-1 2mgARS 1mg: Placebo: albuterol: ARS 2mg |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARS-1 1 mgARS-1 1 mg | Drug | Sequence 1, Sequence 2 |
| Albuterol MDI180 mcg | Drug | Sequence 1, Sequence 2 |
| PlaceboPlacebo | Drug | Sequence 1, Sequence 2 |
| ARS-1 2mgARS-1 2mg | Drug | Sequence 1, Sequence 2 |
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarina Tanimoto, MD, PhD study director
ARS Pharmaceuticals, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARS-1 1 mg, Albuterol MDI and ARS-1 2mg in people with Asthma, run by ARS Pharmaceuticals, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of ARS-1 Versus Albuterol and Placebo (time frame: From baseline (timepoints 0) to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.