Assessing the Efficacy of CREWS01 to Decrease Usage of Rescue Inhalers in Moderate to Severe Asthmatic Adults
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | July 2014 |
| End Date: | September 2014 |
| Contact: | Kathy Miles, B.S., CCRP |
| Email: | kmiles@gru.edu |
| Phone: | 7067216247 |
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.
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.
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.
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
We found this trial at
1
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Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
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