Development of a Breath Analyzer for Asthma Screening
1 other identifier
observational
2,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2004
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 11, 2006
CompletedFirst Posted
Study publicly available on registry
October 12, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedOctober 12, 2006
October 1, 2006
October 11, 2006
October 11, 2006
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Healthy subjects (n=120)
- Asthma (Total n=450) \[diagnosed according to NHLBI/ NAEPP Guidelines (1998)\]
- Non-treated or B2-agonist treated asthmatics (n=150),
- Glucocorticoid treated asthmatics, (n=150),
- Leukotriene Antagonist treated asthmatics, (n=75),
- Glucocorticoid and Leukotriene Antagonists treated asthmatics, (n= 75).
- Acute respiratory illnesses (n=65
- Sinusitis (Acute and Chronic),
- Influenza,
- Common cold,
- Pneumonia,
- Related symptoms, but no diagnosis.
- Allergies (n=65)
- Atopic dermatitis,
- Allergic rhinitis,
- +1 more criteria
You may not qualify if:
- Younger than 4
- Older than 65
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ekips Technologieslead
- American Lung Associationcollaborator
Study Sites (1)
Ekips Technologies, Inc.
Norman, Oklahoma, 73069, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Khosrow Namjou, Ph.D.
Ekips Technologies, Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- DEFINED POPULATION
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 11, 2006
First Posted
October 12, 2006
Study Start
September 1, 2004
Study Completion
February 1, 2007
Last Updated
October 12, 2006
Record last verified: 2006-10