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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: ARS-1; Drug: Albuterol MDI; Drug: Placebo

• Registration Number: NCT05363670
• Lead Sponsor: ARS Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-06
• Study Start: 2022-07-28
• Primary Completion: 2024-02-02
• Study Completion: 2024-02-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1 mg/100 µL dose of ARS-1	ARS-1	-
2 mg/100 µL dose of ARS-1	ARS-1	-
albuterol MDI (180 mcg)	Albuterol MDI	-
placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (4)

University of South Florida; 🇺🇸 Tampa, Florida, United States

Bernstein Clinical Research Center, LLC; 🇺🇸 Cincinnati, Ohio, United States

Institute for Asthma and Allergy; 🇺🇸 Chevy Chase, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States