Overview

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

Status:
Unknown status
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Global United Pharmaceutical Corporation
Treatments:
Antipyrine
Benzocaine
Mineral Oil
Pharmaceutical Solutions
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