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Assessing the Efficacy of CREWS01 to Decrease Usage of Rescue Inhalers in Moderate to Severe Asthmatic Adults

NCT02153541 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-02-08

No results posted yet for this study

Summary

This is a double-blind, randomized, placebo-controlled, proof of concept, study in adults with poorly controlled moderate to severe asthma. The researchers believe that by using a local anesthetic to block a certain nerve in the ear, it will improve all aspects of asthma, such as decreasing the numbers of times patients have to use a rescue inhaler, and improving asthma treatment assessment questionnaire scores, with no bad changes to lung function and inflammation.

Conditions

Interventions

DRUG

Antipyrine-benzocaine otic solution

Participants receiving antipyrine-benzocaine otic solution are expected to decrease usage of rescue inhalers.

OTHER

Glycerin with Oxyquinoline Sulfate

50% of participants will receive the glycerin with oxyquinoline sulfate. These participants will be randomly selected and unaware that they are receiving the placebo and are expected to have no change in usage of rescue inhalers.

Sponsors & Collaborators

  • Global United Pharmaceutical Corporation

    lead INDUSTRY

Principal Investigators

  • John D Prosser, MD · Augusta University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2023-08-01
Completion
2023-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02153541 on ClinicalTrials.gov