Assessing the Efficacy of CREWS01 to Decrease Usage of Rescue Inhalers in Moderate to Severe Asthmatic Adults (CREWS01)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02153541|
Recruitment Status : Unknown
Verified May 2014 by Global United Pharmaceutical Corporation.
Recruitment status was: Not yet recruiting
First Posted : June 3, 2014
Last Update Posted : June 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Antipyrine-benzocaine otic solution Other: Mineral oil||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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 Start Date :||July 2014|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2014|
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.
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 Name: mineral oil, liquid paraffin
Active Comparator: Antipyrine-benzocaine otic solution
Will be used on 50% of participants.
Drug: Antipyrine-benzocaine otic solution
Participants receiving antipyrine-benzocaine otic solution are expected to decrease usage of rescue inhalers.
- 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 ]
- Improvement of spirometry scores in moderate to severe asthmatic adults [ Time Frame: four weeks for each participant ]
- Evaluate the safety of using topical anesthetics in moderate to sever asthmatic adults [ Time Frame: four weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153541
|Contact: Kathy Miles, B.S., CCRPfirstname.lastname@example.org|
|United States, Georgia|
|Georgia Regents University||Not yet recruiting|
|Augusta, Georgia, United States, 30912|
|Contact: Kathy Miles, B.S., CCRP 706-721-6247|
|Principal Investigator:||Anthony C Hughes, MD||Augusta University|