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
ARS-1 is being developed for patients as a needleless alternative route of epinephrine administration for the management of refractory asthma symptoms.
Exclusion Criteria:
ARS 2mg: albuterol: Placebo: ARS 1mg
Drug: ARS-1 1 mg · Drug: Albuterol MDI · Drug: Placebo · Drug: ARS-1 2mg
ARS 1mg: Placebo: albuterol: ARS 2mg
Drug: ARS-1 1 mg · Drug: Albuterol MDI · Drug: Placebo · Drug: ARS-1 2mg
ARS-1 1 mg
180 mcg
Placebo
ARS-1 2mg
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
| Milestone | Sequence 1 | Sequence 2 |
|---|---|---|
| Started | 12 | 6 |
| Completed | 12 | 6 |
| Not completed | 0 | 0 |
Difference in forced expiratory volume in 1 second (FEV1) based on area under the curve (AUC)
| FEV1 L per hour | ARS-1 1mg | ARS-1 2mg | Placebo | Albuterol |
|---|---|---|---|---|
| Effect of ARS-1 Versus Albuterol and Placebo | 0.150 ± 0.223 | 0.233 ± 0.216 | -0.002 ± 0.118 | 0.378 ± 0.265 |
Collected over 5 hours. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ARS-1 1mg | 0/18 (0%) | 0/18 (0%) | 5/18 (27.8%) |
| ARS-1 2mg | 0/18 (0%) | 0/18 (0%) | 7/18 (38.9%) |
| Placebo | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) |
| Albuterol | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Event | ARS-1 1mg | ARS-1 2mg | Placebo | Albuterol |
|---|---|---|---|---|
| Nasal discomfortGeneral disorders | 5/18 | 7/18 | 1/18 | 0/18 |
| Age, Categorical(Participants) | Interventional Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 18 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Interventional Treatment |
|---|---|
| Female | 9 |
| Male | 9 |
| Race and Ethnicity Not Collected(Participants) | Interventional Treatment |
|---|
| Region of Enrollment(participants) | Interventional Treatment |
|---|---|
| United States | 18 |
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ARS Pharmaceuticals, Inc.