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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Participants receiving antipyrine-benzocaine otic solution are expected to decrease usage of rescue inhalers.
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.
Augusta University
Augusta, Georgia, United States
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.
Time frame: Each participant is studied for four weeks
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.
Time frame: Each participant is studied for four weeks
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