Administration of ARS-1 or Albuterol in Subjects With Persistent Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05363670
• Other study ID #: EPI A01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 28, 2022
• Est. completion date: January 2024

Study information

• Verified date: January 2024
• Source: ARS Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

ARS-1 is being developed for patients as a needleless alternative route of epinephrine administration for the management of refractory asthma symptoms.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• ARS-1
ARS-1
• Albuterol MDI
180 mcg
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Institute for Asthma and Allergy	Chevy Chase	Maryland
United States	Bernstein Clinical Research Center, LLC	Cincinnati	Ohio
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ARS Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of ARS-1 versus Albuterol and placebo	Difference in forced expiratory volume in 1 second (FEV1) based on area under the curve (AUC)	From baseline (timepoints 0) to 1 hour