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OpenTrials
Completed

NCT Number: NCT05363670

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

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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Key information

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of South Florida, Tampa, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARS-1 1 mg

Drug

ARS-1 1 mg

Albuterol MDI

Drug

180 mcg

Placebo

Drug

Placebo

ARS-1 2mg

Drug

ARS-1 2mg

Primary outcomes

  1. Effect of ARS-1 Versus Albuterol and Placebo

    Time frame: From baseline (timepoints 0) to 1 hour

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

Sponsors and collaborators

Lead sponsor

ARS Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 6, 2022
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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