Development of a Breath Analyzer for Asthma Screening

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. Identifier: NCT00386737
Recruitment Status : Unknown
Verified October 2006 by Ekips Technologies.
Recruitment status was:  Recruiting
First Posted : October 12, 2006
Last Update Posted : October 12, 2006
American Lung Association
Information provided by:
Ekips Technologies

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.

Condition or disease

  Show Detailed Description

Study Type : Observational
Enrollment : 2000 participants
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
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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,
    • Seasonal allergies.

Exclusion Criteria:

  • Younger than 4
  • Older than 65
  • Pregnant

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 identifier (NCT number): NCT00386737

Contact: Tanya Reich, BS (405) 307-8803 ext 114
Contact: G. Carl Gibson, BBA (405) 307-8803 ext 110

United States, Oklahoma
Ekips Technologies, Inc. Recruiting
Norman, Oklahoma, United States, 73069
Contact: Tanya Reich, BS    405-307-8803 ext 114   
Contact: G. Carl Gibson, BBA    (405) 307-8803 ext 110   
Sponsors and Collaborators
Ekips Technologies
American Lung Association
Principal Investigator: Khosrow Namjou, Ph.D. Ekips Technologies, Inc. Identifier: NCT00386737     History of Changes
Other Study ID Numbers: NIH-2-R44-HL070344-02
First Posted: October 12, 2006    Key Record Dates
Last Update Posted: October 12, 2006
Last Verified: October 2006

Keywords provided by Ekips Technologies:
Breath Testing
Laser Spectroscopy
Nitric Oxide
Lower Airway Inflammation
Carbon Dioxide

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases