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

A

ARS Pharmaceuticals

Status and phase

Active, not recruiting
Phase 2

Conditions

Asthma

Treatments

Drug: ARS-1
Drug: Placebo
Drug: Albuterol MDI

Study type

Interventional

Funder types

Industry

Identifiers

NCT05363670
EPI A01

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

12 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

30 participants in 4 patient groups, including a placebo group

1 mg/100 µL dose of ARS-1
Active Comparator group
Treatment:
Drug: ARS-1
2 mg/100 µL dose of ARS-1
Active Comparator group
Treatment:
Drug: ARS-1
albuterol MDI (180 mcg)
Active Comparator group
Treatment:
Drug: Albuterol MDI
placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

4

Loading...

Central trial contact

Cara Casseday

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems