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

NCT ID: NCT02153541

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2023-08-01

Brief 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.

Detailed Description

The proposed four-week, double-blind, placebo controlled study is designed to test the hypothesis that topical auricular anesthesia of the vagus nerve decreases the need for the usage of rescue inhalers in moderate to severe asthma in adults.

We anticipate that up to 50 patients will be enrolled in the trial. Particularly severe risks are not anticipated based on the prior investigational experience with this drug. This trial will be used to generate experience and data to support the design of a larger, crossover, comparator trial investigating the efficacy of antipyrine-benzocaine in reducing the need for rescue inhalers and hospital admissions in moderate to severe asthmatic adults.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Glycerin with Oxyquinoline Sulfate

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.

Group Type: PLACEBO_COMPARATOR

Glycerin with Oxyquinoline Sulfate

Intervention Type: OTHER

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.

Antipyrine-benzocaine otic solution

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 Type: ACTIVE_COMPARATOR

Antipyrine-benzocaine otic solution

Intervention Type: DRUG

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

Interventions

Antipyrine-benzocaine otic solution

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

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Moderate to severe asthma
• Rescue inhaler 3 times per week
• Be able to give informed consent
• Must be on inhaled corticosteroid and long-acting beta agonist (LABA), (either individually or as a combination product) and report using a short-acting beta agonist (SABA) three or more times a week in at least 2 or 3 weeks prior to stud enrollment
• Moderate or severe persistent asthma according to the National Heart, Lung, and Blood Institute (NHLBI) Guidelines, (EPR 2007)
• At least one appointment scheduled with the asthma physician during the 4 weeks of participation.
• Must be able to complete questionnaires over the phone or in person
• Must be able to maintain a basic diary/log of inhaler use and any side effects for 30 days.

Exclusion Criteria

• Severe psychiatric or cognitive problems
• Known or suspected sensitivity to the investigational medication
• Have a stenotic ear canal
• Have a perforated ear drum
• Active Otitis Media, Otitis Externa, or Mastoiditis
• Allergic to Benzocaine
• Unable to communicate in English
• Any other significant cardiopulmonary disease
• Smokers
• Hospitalized in the last 6 months for pneumonia
• Long term or lingering side effects to COVID19
• Lack of telephone or mobile phone
• Subjects who have received any investigational drug for asthma in the past 60 days

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Global United Pharmaceutical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John D Prosser, MD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

Augusta University

Augusta, Georgia, United States

Countries

United States

Central Contacts

Carol Smith

Role: CONTACT

csmith@augusta.edu

7067219680

Facility Contacts

Carol Smith

Role: primary

csmith@augusta.edu

706-721-9680

Other Identifiers

CREWS01

Identifier Type: -

Identifier Source: org_study_id