Asthma
Conditions
Brief summary
ARS-1 is being developed for patients as a needleless alternative route of epinephrine administration for the management of refractory asthma symptoms.
Interventions
DRUGARS-1 1 mg
ARS-1 1 mg
DRUGAlbuterol MDI
180 mcg
DRUGPlacebo
Placebo
DRUGARS-1 2mg
ARS-1 2mg
Sponsors
ARS Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of ARS-1 Versus Albuterol and Placebo | From baseline (timepoints 0) to 1 hour | Difference in forced expiratory volume in 1 second (FEV1) based on area under the curve (AUC) |
Countries
United States
Contacts
STUDY_DIRECTORSarina Tanimoto, MD, PhD
ARS Pharmaceuticals, Inc.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 5 / 18 | 7 / 18 | 1 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 |
Outcome results
None listed