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

NCT02153541 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: CREWS01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement of spirometry scores in moderate to severe asthmatic adults

  Each participant is studied for four weeks

Other Outcomes (1)

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

  Each participant is studied for four weeks

Study Arms (2)

Glycerin with Oxyquinoline Sulfate

PLACEBO COMPARATOR

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

Antipyrine-benzocaine otic solution

ACTIVE COMPARATOR

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

Interventions

Antipyrine-benzocaine otic solution DRUG

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

Antipyrine-benzocaine otic solution

Glycerin with Oxyquinoline Sulfate 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.

Glycerin with Oxyquinoline Sulfate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Global United Pharmaceutical Corporation: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30901, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Glycerol; Oxyquinoline

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Hydroxyquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• John D Prosser, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol Smith

CONTACT

7067219680; csmith@augusta.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: June 3, 2014
• Study Start: April 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after completion of phase 3 clinical trial
• Access Criteria: undetermined

Locations

US (1)