Trial | NCT02153541  Report issue

Title

Assessing the Efficacy of CREWS01 to Decrease Usage of Rescue Inhalers in Moderate to Severe Asthmatic Adults
Assessing the Efficacy of Antipyrine Benzocaine Otic Solution in the Ear Canal to Decrease Usage of Rescue Inhalers in Moderate to Severe Asthmatic Adults.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
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 Started
Jul 31
2014
Primary Completion
Sep 30
2014
Anticipated
Study Completion
Sep 30
2014
Anticipated
Last Update
Jun 03
2014
Estimate

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.

  • Other names: mineral oil, liquid paraffin

Mineral oil Placebo Comparator

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.

Antipyrine-benzocaine otic solution Active Comparator

Will be used on 50% of participants.

Criteria 

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
No Results Posted