AsthmaNCT00386737
Development of a Breath Analyzer for Asthma Screening
An observational study of Asthma, run by Ekips Technologies at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Feb 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Show all 16Show fewer
- 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.
Who cannot join
- Younger than 4
- Older than 65
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ekips Technologies, Inc.
Norman, Oklahoma, 73069
Tanya Reich, BS, 405-307-8803 ext. 114, treich@ekipstech.com
G. Carl Gibson, BBA, (405) 307-8803 ext. 110, cgibson@ekipstech.com
About this study
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.
Read the detailed description
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:
- 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), b) Influenza, c) Common cold, d)Pneumonia, e)Related symptoms, but no diagnosis.
- 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.
- Conditions
- Asthma
- Keywords
- Asthma, Breath Testing, Laser Spectroscopy, eNO, Nitric Oxide, Lower Airway Inflammation, Carbon Dioxide, CO2
- Medical subject headings
- Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startSep 2004
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 2,000 participants
Sponsor and investigators
- Lead sponsor
- Ekips Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American Lung Association
- Investigators
- Khosrow Namjou, Ph.D., Principal investigator, Ekips Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386737
- Sponsor's protocol ID
- NIH-2-R44-HL070344-02
- Status last verified
- Oct 2006
- First submitted
- 11 Oct 2006
- Last updated
- 12 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Breath Analyzer for Asthma Screening
- ClinicalTrials.gov ID
- NCT00386737
- Acronym / sponsor ID
- NIH-2-R44-HL070344-02
- Conditions
- Asthma
- Keywords
- Asthma, Breath Testing, Laser Spectroscopy, eNO, Nitric Oxide, Lower Airway Inflammation, Carbon Dioxide, CO2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants
- Lead sponsor
- Ekips TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- American Lung Association
- Study start
- Sep 2004
- Study completion
- Feb 2007
- First posted
- 12 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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), b) Influenza, c) Common cold, d)Pneumonia, e)Related symptoms, but no diagnosis.
- 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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 4 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Healthy subjects (n=120)
- Asthma (Total n=450) [diagnosed according to NHLBI/ NAEPP Guidelines (1998)]
- Acute respiratory illnesses (n=65
- Allergies (n=65)
Key exclusion criteria (3 listed)
- Younger than 4
- Older than 65
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khosrow Namjou, Ph.D. principal investigator
Ekips Technologies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Ekips Technologies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tanya Reich, BS ((405) 307-8803 ext. 114, treich@ekipstech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2006; AzTrials last refreshed its copy on 6 Nov 2026.