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

Primary Purpose

Asthma

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ARS-1

Albuterol MDI

Placebo

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of South FloridaRecruiting
Institute for Asthma and Allergy
Massachusetts General HospitalRecruiting
Bernstein Clinical Research Center, LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1 mg/100 µL dose of ARS-1

2 mg/100 µL dose of ARS-1

albuterol MDI (180 mcg)

placebo

Arm Description

Outcomes

Primary Outcome Measures

Effect of ARS-1 versus Albuterol and placebo

Difference in forced expiratory volume in 1 second (FEV1) based on area under the curve (AUC)

Secondary Outcome Measures

Full Information

NCT ID

NCT05363670

First Posted

April 27, 2022

Last Updated

July 17, 2023

Sponsor

ARS Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05363670

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 28, 2022 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ARS Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1 mg/100 µL dose of ARS-1

Arm Type

Active Comparator

Arm Title

2 mg/100 µL dose of ARS-1

Arm Type

Active Comparator

Arm Title

albuterol MDI (180 mcg)

Arm Type

Active Comparator

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

ARS-1

Intervention Description

ARS-1

Intervention Type

Drug

Intervention Name(s)

Albuterol MDI

Intervention Description

180 mcg

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Effect of ARS-1 versus Albuterol and placebo

Description

Difference in forced expiratory volume in 1 second (FEV1) based on area under the curve (AUC)

Time Frame

From baseline (timepoints 0) to 1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cara Casseday

Phone

619-990-8136

carac@pacificlinkconsulting.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarina Tanimoto, MD, PhD

Organizational Affiliation

ARS Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

University of South Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Renee Smith

Phone

813-631-4024

catherinesmith@usf.edu

First Name & Middle Initial & Last Name & Degree

Thomas Casale, MD

Facility Name

Institute for Asthma and Allergy

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lili Wan

Phone

301-986-0670

iaaresearchwan@gmail.com

First Name & Middle Initial & Last Name & Degree

Henry Li, M.D.

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jannat G Gill

Phone

617-643-8683

Jgill0@mgh.harvard.edu

First Name & Middle Initial & Last Name & Degree

Wayne G Shreffler, M.D,

Facility Name

Bernstein Clinical Research Center, LLC

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45236

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen Berendts

Phone

531-354-1746

kbarendts@bernsteincrc.com

First Name & Middle Initial & Last Name & Degree

David Bernstein, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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