CompletedPhase 2

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

United States18 participantsStarted 2022-07-28

Plain-language summary

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

Who can participate

Age range

12 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 2 trial comparing a new drug called ARS-1 against albuterol and a placebo for persistent asthma — since it's already completed, would my doctor be able to access any published results or safety data from it, and what do those results suggest about how ARS-1 compares to albuterol?
2Since albuterol is already a well-established rescue inhaler for asthma, what would be the potential benefit of switching to or trying ARS-1 instead, and is there any reason my doctor thinks a newer option would be worth considering for my specific situation?
3Because this trial included a placebo group, some participants would have received no active treatment during the study period — how does my doctor feel about that kind of design when it comes to managing persistent asthma, which can sometimes be serious?
4Now that the trial is completed and I can no longer enroll, are there any follow-up studies or next-phase trials involving ARS-1 that my doctor thinks might be worth looking into?
5Given that this was only a Phase 2 study, meaning it was still relatively early in testing ARS-1's safety and effectiveness, does my doctor feel the existing evidence is strong enough to inform my treatment decisions, or would sticking with established asthma medications be a safer path for now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effect of ARS-1 Versus Albuterol and Placebo

Timeframe: From baseline (timepoints 0) to 1 hour

Trial details

NCT IDNCT05363670

SponsorARS Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-02

Results submitted2026-05-14

View on ClinicalTrials.gov More Asthma trials

Who can participate

Age range

12 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.