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

Assessing the Efficacy of Antipyrine Benzocaine Otic Solution in the Ear Canal to Decrease Usage of Rescue Inhalers in Moderate to Severe Asthmatic Adults.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: Antipyrine-benzocaine otic solution; Other: Glycerin with Oxyquinoline Sulfate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Carol Smith; Phone Number: 7067219680; Email: csmith@augusta.edu

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30901
      • Augusta University
      • Contact: Carol Smith; Phone Number: 706-721-9680; Email: csmith@augusta.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 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.	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.
ACTIVE_COMPARATOR: 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.	Drug: Antipyrine-benzocaine otic solution; Participants receiving antipyrine-benzocaine otic solution are expected to decrease usage of rescue inhalers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	We anticipate 50% of patients that receive the active ingredient will decrease the usage of rescue inhalers by 50%. If the test of the two-factor interaction in the repeated measures mixed model analysis is statistically significant, and the magnitude of the change in the Crews group is at least 50%, the Crews Maneuver will be considered effective.	Each participant is studied for four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of spirometry scores in moderate to severe asthmatic adults	We anticipate 50% of patients that receive the active ingredient will not show a significant decline in spirometry scores and eNO results that do not show a significant increase in subjects on the active drug compared to the placebo, and improvement in both ACT and ATAQ scores of at least 25% over the 4 weeks of study.	Each participant is studied for four weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the safety of using topical anesthetics in moderate to severe asthmatic adults	We anticipate the active medication is safe for topical usage in moderate to severe asthmatic adults. The common side effects of topical anesthetics include, but are not limited to, stinging, burning or itching of the ear canal.	Each participant is studied for four weeks

Collaborators and Investigators

• Sponsor: Global United Pharmaceutical Corporation
• Investigators: Principal Investigator: John D Prosser, MD, Augusta University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2023
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: June 2, 2014
• First Posted (ESTIMATE): June 3, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Protective Agents; Anesthetics, Local; Cryoprotective Agents; Benzocaine; Glycerol; Antipyrine
• Other Study ID Numbers: CREWS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing after phase 3 clinical trial completed
• IPD Sharing Time Frame: 6 months after completion of phase 3 clinical trial
• IPD Sharing Access Criteria: undetermined
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No