albuterol MDI (180 mcg) for Asthma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Institute for Asthma and Allergy, Chevy Chase, MD
Asthma
ARS-1 - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a needle-free way to give epinephrine to people with severe asthma who aren't helped by other treatments. The albuterol MDI (180 mcg) is used to help treat asthma by widening the airways in the lungs to make it easier to breathe.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Asthma

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: From baseline (timepoints 0) to 1 hour

Hour 1
Effect of ARS-1 versus Albuterol and placebo

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Asthma

Trial Design

4 Treatment Groups

albuterol MDI (180 mcg)
1 of 4
2 mg/100 µL dose of ARS-1
1 of 4
1 mg/100 µL dose of ARS-1
1 of 4
placebo
1 of 4
Active Control
Non-Treatment Group

30 Total Participants · 4 Treatment Groups

Primary Treatment: albuterol MDI (180 mcg) · Has Placebo Group · Phase 2

placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
albuterol MDI (180 mcg)
Drug
ActiveComparator Group · 1 Intervention: Albuterol MDI · Intervention Types: Drug
2 mg/100 µL dose of ARS-1
Drug
ActiveComparator Group · 1 Intervention: ARS-1 · Intervention Types: Drug
1 mg/100 µL dose of ARS-1
Drug
ActiveComparator Group · 1 Intervention: ARS-1 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline (timepoints 0) to 1 hour
Closest Location: Institute for Asthma and Allergy · Chevy Chase, MD
Photo of maryland 1Photo of maryland 2Photo of maryland 3
2007First Recorded Clinical Trial
1 TrialsResearching Asthma
17 CompletedClinical Trials

Who is running the clinical trial?

ARS Pharmaceuticals, Inc.Lead Sponsor
2 Previous Clinical Trials
47 Total Patients Enrolled
Sarina Tanimoto, MD, PhDStudy DirectorARS Pharmaceuticals, Inc.
1 Previous Clinical Trials
32 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between the ages of 12 and 65 years, inclusive.\n
You have had asthma for at least four weeks.
You have a reversible bronchoconstriction.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.