Development of a Breath Analyzer for Asthma Screening
Recruitment status was: Recruiting
Annually, asthma is responsible for 1 million emergency room visits, 400,000 hospitalizations, and 5000 deaths according to the NHLBI. In addition, 10 million missed school-days per year and 100 million days of restricted activity are attributed to this disease. While there is no known cause or cure for asthma, recent studies have shown that hospitalizations and emergency room visits can be reduced by as much as 78% and 73%, respectively, when the disease is properly managed. According to the EPA, the occurance of children with asthma more than doubled the rate of two decades ago; in 2001 the percentage of asthmatic children was 8.7% (6.3 million children).
Properly managing asthma is nontrivial and can often require an asthma specialist. The difficulty in diagnosing and managing asthma lies primarily in the lack of available clinical technologies capable of assessing airway inflammation, an early and persistent component of asthma. Accordingly, the National Institutes of Health (NIH) guidelines for the diagnosis and management of asthma strongly recommend long term anti-inflammatory therapies, such as oral or inhaled corticosteroids, to reverse airway inflammation in an effort to prevent irreversible airway damage, termed “airway remodeling”. The medical community has expressed the need for more objective and noninvasive measures of airway inflammation for diagnosing asthma and monitoring the effectiveness and compliance of anti-inflammatory therapies.
The clinical research plan is designed to evaluate airway inflammation associated with asthma. In this human subjects study, a non-invasive exhaled breath analysis sensor, called the Breathmeter, will be used to measure eNO concentrations in children and adults (ages 4-65) with a broad range of respiratory disorders as well as those with no known respiratory disorders. Breath donations will be simple and straightforward presenting little to no discomfort to volunteers.
|Study Design:||Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
|Official Title:||Development of a Breath Analyzer for Asthma Screening|
|Study Start Date:||September 2004|
|Estimated Study Completion Date:||February 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386737
|United States, Oklahoma|
|Ekips Technologies, Inc.|
|Norman, Oklahoma, United States, 73069|
|Principal Investigator:||Khosrow Namjou, Ph.D.||Ekips Technologies, Inc.|