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Assessing the Efficacy of CREWS01 to Decrease Usage of Rescue Inhalers in Moderate to Severe Asthmatic Adults (CREWS01)

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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
Sponsor:
Information provided by (Responsible Party):
Global United Pharmaceutical Corporation

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Antipyrine-benzocaine otic solution Other: Mineral oil Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Minerals

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Improvement of spirometry scores in moderate to severe asthmatic adults [ Time Frame: four weeks for each participant ]

Other Outcome Measures:
  1. Evaluate the safety of using topical anesthetics in moderate to sever asthmatic adults [ Time Frame: four weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Kathy Miles, B.S., CCRP 7067216247 kmiles@gru.edu

Locations
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United States, Georgia
Georgia Regents University Not yet recruiting
Augusta, Georgia, United States, 30912
Contact: Kathy Miles, B.S., CCRP    706-721-6247      
Sponsors and Collaborators
Global United Pharmaceutical Corporation
Investigators
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Principal Investigator: Anthony C Hughes, MD Augusta University

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Responsible Party: Global United Pharmaceutical Corporation
ClinicalTrials.gov Identifier: NCT02153541     History of Changes
Other Study ID Numbers: CREWS01
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antipyrine
Benzocaine
Mineral Oil
Pharmaceutical Solutions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Emollients
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents