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

Overview

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.

Full Title of Study: “Assessing the Efficacy of Antipyrine Benzocaine Otic Solution in the Ear Canal to Decrease Usage of Rescue Inhalers in Moderate to Severe Asthmatic Adults.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: September 2014

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.

Interventions

  • Drug: Antipyrine-benzocaine otic solution
    • Participants receiving antipyrine-benzocaine otic solution are expected to decrease usage of rescue inhalers.
  • Other: Mineral oil
    • 50% of participants will receive the mineral oil. 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.

Arms, Groups and Cohorts

  • Placebo Comparator: Mineral oil
    • For those participants who receive mineral oil placebo, we do not anticipate any change in the usage of rescue inhalers, spirometer scores, asthma diaries, and expired fractionated nitrous oxide levels.
  • Active Comparator: Antipyrine-benzocaine otic solution
    • Will be used on 50% of participants.

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: Each participant is studied for four weeks

Secondary Measures

  • Improvement of spirometry scores in moderate to severe asthmatic adults
    • Time Frame: four weeks for each participant

Participating in This Clinical Trial

Inclusion Criteria

  • Moderate to severe asthma
  • Rescue inhaler 3 times per week
  • Be able to give informed consent
  • Must be an 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
  • Unable to communicate in English
  • Any other significant cardiopulmonary disease
  • Smokers
  • Lack of telephone
  • Subjects who have received any investigational drug for asthma in the past 60 days

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Global United Pharmaceutical Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anthony C Hughes, MD, Principal Investigator, Augusta University
  • Overall Contact(s)
    • Kathy Miles, B.S., CCRP, 7067216247, kmiles@gru.edu

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