Administration of ARS-1 or Albuterol in Subjects With Persistent Asthma
Completed · Phase 2 · Has a placebo group
Conditions studied: Asthma
In brief
ARS-1 is being developed for patients as a needleless alternative route of epinephrine administration for the management of refractory asthma symptoms.
Key facts
- Study ID
- NCT05363670
- Run by
- ARS Pharmaceuticals, Inc.
- People needed
- 18
- Starts
- 2022-07-28
- Expected to finish
- 2024-02-02
- Last updated by the study team
- 2026-07-14
Who can join
Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of South Florida — Tampa, Florida, United States
- Institute for Asthma and Allergy — Chevy Chase, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Bernstein Clinical Research Center, LLC — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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