Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386737
Status:
UNKNOWN
Last Update Posted:
2006-10-12
First Post:
2006-10-11
Brief Title:
Development of a Breath Analyzer for Asthma Screening
Sponsor:
Ekips Technologies
Organization:
Ekips Technologies
Study Overview
Official Title:
Development of a Breath Analyzer for Asthma Screening
Status:
UNKNOWN
Status Verified Date:
2006-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Annually asthma is responsible for 1 million emergency room visits 400000 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 87 63 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
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
1 Healthy subjects n120
2 Asthma Total n450 diagnosed according to NHLBI NAEPP Guidelines 1998
1 Non-treated or B2-agonist treated asthmatics n150
2 Glucocorticoid treated asthmatics n150
3 Leukotriene Antagonist treated asthmatics n75
4 Glucocorticoid and Leukotriene Antagonists treated asthmatics n 75
3 Acute respiratory illnesses n65
a Sinusitis Acute and Chronic b Influenza c Common cold dPneumonia eRelated symptoms but no diagnosis
4 Allergies n65 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 subjects 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
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 n120
2 Asthma Total n450 diagnosed according to NHLBI NAEPP Guidelines 1998
1 Non-treated or B2-agonist treated asthmatics n150
2 Glucocorticoid treated asthmatics n150
3 Leukotriene Antagonist treated asthmatics n75
4 Glucocorticoid and Leukotriene Antagonists treated asthmatics n 75
3 Acute respiratory illnesses n65
a Sinusitis Acute and Chronic b Influenza c Common cold dPneumonia eRelated symptoms but no diagnosis
4 Allergies n65 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 subjects 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None