Antipyrine-benzocaine otic solution for Asthma (CREWS01 Trial)

Phase 2

Waitlist Available

Led By Anthony C Hughes, MD

Research Sponsored by Global United Pharmaceutical Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up each participant is studied for four weeks

Awards & highlights

All Individual Drugs Already Approved

Summary

This trialtests if blocking a nerve in the ear can improve asthma symptoms & reduce reliance on rescue inhalers without harming lung function.

Eligible Conditions

Asthma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ each participant is studied for four weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~each participant is studied for four weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and each participant is studied for four weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of CREWS01 (topical auricular anesthesia of the vagus nerve) to decrease usage of rescue inhalers in moderate to severe asthmatic adults Change in usage of rescue inhalers in moderate to severe asthmatic adults in four weeks

Secondary study objectives

Improvement of spirometry scores in moderate to severe asthmatic adults

Other study objectives

Evaluate the safety of using topical anesthetics in moderate to severe asthmatic adults

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Antipyrine-benzocaine otic solutionActive Control1 Intervention

Will be used on 50% of participants, we anticipate reduction in the usage of rescue inhalers, spirometer scores, asthma diaries, and expired fractionated nitrous oxide levels.

Group II: Glycerin with Oxyquinoline SulfatePlacebo Group1 Intervention

For those participants who receive glycerin with oxyquinoline sulfate placebo, we do not anticipate any change in the usage of rescue inhalers, spirometer scores, asthma diaries, and expired fractionated nitrous oxide levels.

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