Development of a Breath Analyzer for Asthma Screening
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 4 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | September 2004 |
| End Date: | February 2007 |
| Contact: | Tanya Reich, BS |
| Email: | treich@ekipstech.com |
| Phone: | (405) 307-8803 |
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
