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

Sponsor
ARS Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05363670
Collaborator
(none)
30
Enrollment
3
Locations
4
Arms
3.2
Anticipated Duration (Months)
10
Patients Per Site
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 28, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1 mg/100 µL dose of ARS-1

Drug: ARS-1
ARS-1
Active Comparator: 2 mg/100 µL dose of ARS-1

Drug: ARS-1
ARS-1
Active Comparator: albuterol MDI (180 mcg)

Drug: Albuterol MDI
180 mcg
Placebo Comparator: placebo

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Is a male or female subject between the ages of 12 and 65 years, inclusive.
    1. Asthma that has been stable for at least four weeks prior to screening as defined by clinical history.
    1. Reversible bronchoconstriction.
    1. Has body weight more than 30 kilogram (kg) and body mass index between 18 and 34 kg/m², inclusive.
    1. Has no medical history of hypertension and cardiovascular disease in the last 10 years.
    1. 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.
    1. Patients receiving beta blocker.
    1. Has any clinically significant medical condition or physical exam finding as deemed inappropriate by the Investigator.
    1. Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram.
    1. Has mucosal inflammatory disorders.
    1. Has had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of South Florida Tampa Florida United States 33613
2 Institute for Asthma and Allergy Chevy Chase Maryland United States 20815
3 Bernstein Clinical Research Center, LLC Cincinnati Ohio United States 45236

Sponsors and Collaborators

  • ARS Pharmaceuticals, Inc.

Investigators

  • Study Director: Sarina Tanimoto, MD, PhD, ARS Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ARS Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT05363670
Other Study ID Numbers:
  • EPI A01
First Posted:
May 6, 2022
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Asthma
Albuterol

Study Results

No Results Posted as of Aug 11, 2022