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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-28

Study Completion Date

2024-02-02

Brief Summary

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

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 mg/100 µL dose of ARS-1

Group Type ACTIVE_COMPARATOR

ARS-1

Intervention Type DRUG

ARS-1

2 mg/100 µL dose of ARS-1

Group Type ACTIVE_COMPARATOR

ARS-1

Intervention Type DRUG

ARS-1

albuterol MDI (180 mcg)

Group Type ACTIVE_COMPARATOR

Albuterol MDI

Intervention Type DRUG

180 mcg

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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ARS-1

Intervention Type DRUG

Albuterol MDI

180 mcg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No