Development of a Breath Analyzer for Asthma Screening
Development of a Breath Analyzer for Asthma Screening
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.
The study plan is divided into two sections: in-clinic studies and large-scale outreach
 screening.

 (A). Clinical Studies The clinical study is intended to obtain data characterizing eNO
 concentrations within individual groups of subjects listed in the inclusion criteria. The
 type of this study is "non-invasive", and the study design is "diagnosis/ treatment
 monitoring, and efficacy". The study will seek to recruit subjects who fall into one of the
 categories listed in the inclusion criteria below. The number of subjects (n) to be recruited
 for each category is given and is estimated based on the past number of subjects mainly at
 the Ekips Technologies, The Oklahoma Allergy & Asthma Clinic, and the Norman Lung Center
 sites.

 Inclusion Criteria (Total Number of Subjects, n = 700)

 Both genders are eligible for this study:

 1. Healthy subjects (n=120)

 2. Asthma (Total n=450) [diagnosed according to NHLBI/ NAEPP Guidelines (1998)]

 1. Non-treated or B2-agonist treated asthmatics (n=150),

 2. Glucocorticoid treated asthmatics, (n=150),

 3. Leukotriene Antagonist treated asthmatics, (n=75),

 4. Glucocorticoid and Leukotriene Antagonists treated asthmatics, (n= 75).

 3. Acute respiratory illnesses (n=65

 a) Sinusitis (Acute and Chronic), b) Influenza, c) Common cold, d)Pneumonia, e)Related
 symptoms, but no diagnosis.

 4. Allergies (n=65) a) Atopic dermatitis, b) Allergic rhinitis, c) Seasonal allergies.

 Healthy Subjects Recruiting

 Healthy subjects will be recruited from visitors and patients at the study sites. Visitors
 may include relatives or friends accompanying patients. Healthy employees at the study sites
 may be asked to participate in the study. Patients, visitors, and employees will be told that
 do not have to participate if they do not want to.

 Exclusion Criteria

 Subjects younger than 4 and older than 65 will be excluded from the study. Pregnant women
 will also be excluded from the study.

 Duration of Participation

 For each visit, the participant in the study will be asked to donate up to 3 breath samples
 for the first visit. The total time required for breath donations and measurements will be
 about 5 minutes. An additional five minutes of a subject's time are needed to complete a
 short interview if the information needed is not already available.

 Asthmatic or suspected asthmatic patients, both treated and non-treated will be asked to
 donate breath during additional visits if convenient. Follow-up measurements may be performed
 during regularly scheduled office visits.
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