Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132834
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2005-08-18
Brief Title:
Methods of Determining Asthma Severity in Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Exhaled Breath Condensates EBC Study Research Plan NIHNIAID Inner City Asthma Consortium ICAC
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
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:
Current methods of measuring asthma severity can be problematic when used with children A measurement called exhaled breath condensates EBC may be a more useful way to determine asthma severity in childhood The purpose of this study is to determine if EBC measurements are useful for determining asthma severity in asthmatic children as compared to currently used laboratory measures
Study hypotheses 1 A broad panel of EBC measures will distinguish asthmatic children not on inhaled corticosteroids ICS from both asthmatic children routinely taking ICS and nonasthmatic controls 2 Standardized equipment and methodologies for EBC collection processing storage shipping and pH and mediator measurements can be developed that will eliminate significant contamination from oropharyngeal saliva and allow for shipping and processing at a central site
Study hypotheses 1 A broad panel of EBC measures will distinguish asthmatic children not on inhaled corticosteroids ICS from both asthmatic children routinely taking ICS and nonasthmatic controls 2 Standardized equipment and methodologies for EBC collection processing storage shipping and pH and mediator measurements can be developed that will eliminate significant contamination from oropharyngeal saliva and allow for shipping and processing at a central site
Detailed Description:
The current national guidelines for assessing asthma severity have several limitations for use in asthmatic children One major limitation is that spirometric measures of airflow limitation including forced expiratory volume in one second FEV1 generally cannot be reliably obtained in children less than 7 years of age Furthermore most children with asthma have essentially normal measures of airflow by spirometry or peak flow so such measurements are generally not useful in diagnosis and treatment Previous studies indicate that lung-specific biomarkers of inflammation such as bronchial hyperresponsiveness measures might simplify improve and optimize the guidelines Collection of EBC samples may also be useful EBC samples can be obtained by noninvasive means and are easier to obtain than conventional samples However contamination by saliva is an issue in collecting EBC samples and standardization of sample collection is needed This study will compare the utility of two different sample collecting equipment the EcoScreen and the R-Tube This study will also evaluate the usefulness of EBC samples in distinguishing between asthmatic children taking ICS asthmatic children not taking ICS and nonasthmatic children
There are 2 parts to this study In Part A two EBC samples will be collected from each participant Some participants will be have one EBC sample taken by the EcoScreen and the other taken by the R-Tube other participants will have both samples taken by the R-Tube In Part B asthmatics taking ICS asthmatics not taking ICS and nonasthmatics will give 2 EBC samples each via the R-Tube
Participants will be asked to complete a questionnaire on their asthma symptoms and allergies and will have a brief physical exam Allergy skin prick testing urine collection measurement of exhaled nitric oxide and conventional incentive spirometry used to obtain several measures of lung function will also occur Participants will also be asked to donate a blood sample
There are 2 parts to this study In Part A two EBC samples will be collected from each participant Some participants will be have one EBC sample taken by the EcoScreen and the other taken by the R-Tube other participants will have both samples taken by the R-Tube In Part B asthmatics taking ICS asthmatics not taking ICS and nonasthmatics will give 2 EBC samples each via the R-Tube
Participants will be asked to complete a questionnaire on their asthma symptoms and allergies and will have a brief physical exam Allergy skin prick testing urine collection measurement of exhaled nitric oxide and conventional incentive spirometry used to obtain several measures of lung function will also occur Participants will also be asked to donate a blood sample
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