Clinical trial NCT02153541: Assessing the Efficacy of CREWS01 to Decrease Usage of Rescue Inhalers in Moderate to Severe Asthmatic Adults
Official title: 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: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Global United Pharmaceutical Corporation
Sponsor class: INDUSTRY
First posted: 2014-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: Each participant is studied for four weeks
Secondary outcomes:
measure: Improvement of spirometry scores in moderate to severe asthmatic adults
timeFrame: Each participant is studied for four weeks
Other outcomes:
measure: Evaluate the safety of using topical anesthetics in moderate to severe asthmatic adults
timeFrame: Each participant is studied for four weeks
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
Study officials:
affiliation: Augusta University
name: John D Prosser, MD
role: PRINCIPAL_INVESTIGATOR
References: