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

NCT05363670 | Completed Phase 2 FDA Drug

• 1 other identifier: EPI A01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

1 mg/100 µL dose of ARS-1

ACTIVE COMPARATOR

Drug: ARS-1

2 mg/100 µL dose of ARS-1

ACTIVE COMPARATOR

Drug: ARS-1

albuterol MDI (180 mcg)

ACTIVE COMPARATOR

Drug: Albuterol MDI

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ARS-1 DRUG

ARS-1

1 mg/100 µL dose of ARS-1; 2 mg/100 µL dose of ARS-1

Albuterol MDI DRUG

180 mcg

albuterol MDI (180 mcg)

Placebo DRUG

Placebo

placebo

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Is a male or female subject between the ages of 12 and 65 years, inclusive.
• \. Asthma that has been stable for at least four weeks prior to screening as defined by clinical history.
• \. Reversible bronchoconstriction.
• \. Has body weight more than 30 kilogram (kg) and body mass index between 18 and 34 kg/m², inclusive.
• \. Has no medical history of hypertension and cardiovascular disease in the last 10 years.
• \. At screening, has stable vital signs.

You may not qualify if:

• \. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition.
• \. Patients receiving beta blocker.
• \. Has any clinically significant medical condition or physical exam finding as deemed inappropriate by the Investigator.
• \. Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram.
• \. Has mucosal inflammatory disorders.
• \. Has had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening.

Sponsors & Collaborators

• ARS Pharmaceuticals, Inc.: lead

Study Sites (4)

University of South Florida

Tampa, Florida, 33613, United States

Location

Institute for Asthma and Allergy

Chevy Chase, Maryland, 20815, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45236, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sarina Tanimoto, MD, PhD

  ARS Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 6, 2022
• Study Start: July 28, 2022
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)