Status:
COMPLETED
Administration of ARS-1 or Albuterol in Subjects With Persistent Asthma
Lead Sponsor:
ARS Pharmaceuticals, Inc.
Conditions:
Asthma
Eligibility:
All Genders
12-65 years
Phase:
PHASE2
Brief Summary
ARS-1 is being developed for patients as a needleless alternative route of epinephrine administration for the management of refractory asthma symptoms.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05363670
Start Date
July 28 2022
End Date
February 2 2024
Last Update
July 30 2024
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University of South Florida
Tampa, Florida, United States, 33613
2
Institute for Asthma and Allergy
Chevy Chase, Maryland, United States, 20815
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States, 45236