AsthmaNCT00132834
Methods of Determining Asthma Severity in Children
An observational study of Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- R-Tube or EcoScreen
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Mar 2004
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Physician-diagnosed asthma
- Symptoms consistent with persistent asthma in the year prior to study entry
- Able to speak and understand English
- Parent or guardian willing to provide informed consent
Who cannot join
- Diagnoses indicating other lung-related disorders (e.g., cystic fibrosis, bronchopulmonary dysplasia [BPD])
- Allergy to latex
- Smoker
- Albuterol use within 12 hours of study entry
- Long-acting bronchodilator or leukotriene modifier use within 24 hours of study entry
- Unable to use the R-Tube. More information on this criterion can be found in the DAIT ICAC-EBC protocol.
- ICS or oral corticosteroid use in the month prior to study entry
About this study
Official title: Exhaled Breath Condensates ("EBC") Study: Research Plan NIH/NIAID: Inner City Asthma Consortium (ICAC)
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- R-Tube or EcoScreen
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-Tube or EcoScreenDevice
Device for collection of exhaled breath condensates (EBC) collection (i.e. condensing and collecting breath vapor from a cold, solid surface)
| Study group | Role | What they receive |
|---|---|---|
| Asthma/no ICS | Asthmatic children who are not currently taking ICS Receives: Device: R-Tube or EcoScreen | |
| Asthma/ICS | Asthmatic children on ICS Receives: Device: R-Tube or EcoScreen | |
| Non-asthmatic children | Children without asthma Receives: Device: R-Tube or EcoScreen |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startNov 2003
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Andrew H. Liu, MD, Principal investigator, National Jewish HealthWayne Morgan, MD, CM, Principal investigator, University of Arizona Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132834
- Sponsor's protocol ID
- DAIT ICAC-05
- Status last verified
- Jan 2013
- First submitted
- 18 Aug 2005
- Last updated
- 25 Jan 2013
- Results posted
- No
Publications
Baraldi E, Ghiro L, Piovan V, Carraro S, Zacchello F, Zanconato S. Safety and success of exhaled breath condensate collection in asthma. Arch Dis Child. 2003 Apr;88(4):358-60. doi: 10.1136/adc.88.4.358.
PubMed 12651772Covar RA, Szefler SJ, Martin RJ, Sundstrom DA, Silkoff PE, Murphy J, Young DA, Spahn JD. Relations between exhaled nitric oxide and measures of disease activity among children with mild-to-moderate asthma. J Pediatr. 2003 May;142(5):469-75. doi: 10.1067/mpd.2003.187.
PubMed 12756375Szefler SJ, Apter A. Advances in pediatric and adult asthma. J Allergy Clin Immunol. 2005 Mar;115(3):470-7. doi: 10.1016/j.jaci.2004.12.1123.
PubMed 15753890
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Condensates ("EBC") Study: Research Plan NIH/NIAID: Inner City Asthma Consortium (ICAC)
- ClinicalTrials.gov ID
- NCT00132834
- Acronym / sponsor ID
- DAIT ICAC-05
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 2003
- Study completion
- Mar 2004 (actual)
- First posted
- 22 Aug 2005 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asthma/no ICS | – | Device: R-Tube or EcoScreenAsthmatic children who are not currently taking ICS |
| Asthma/ICS | – | Device: R-Tube or EcoScreenAsthmatic children on ICS |
| Non-asthmatic children | – | Device: R-Tube or EcoScreenChildren without asthma |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Physician-diagnosed asthma
- Symptoms consistent with persistent asthma in the year prior to study entry
- Able to speak and understand English
- Parent or guardian willing to provide informed consent
Key exclusion criteria (7 listed)
- Diagnoses indicating other lung-related disorders (e.g., cystic fibrosis, bronchopulmonary dysplasia [BPD])
- Allergy to latex
- Smoker
- Albuterol use within 12 hours of study entry
- Long-acting bronchodilator or leukotriene modifier use within 24 hours of study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-Tube or EcoScreenDevice for collection of exhaled breath condensates (EBC) collection (i.e. condensing and collecting breath vapor from a cold, solid surface) | Device | Asthma/ICS, Asthma/no ICS, Non-asthmatic children |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
- Background: PubMed 12651772Baraldi E, Ghiro L, Piovan V, Carraro S, Zacchello F, Zanconato S. Safety and success of exhaled breath condensate collection in asthma. Arch Dis Child. 2003 Apr;88(4):358-60. doi: 10.1136/adc.88.4.358.
- Background: PubMed 12756375Covar RA, Szefler SJ, Martin RJ, Sundstrom DA, Silkoff PE, Murphy J, Young DA, Spahn JD. Relations between exhaled nitric oxide and measures of disease activity among children with mild-to-moderate asthma. J Pediatr. 2003 May;142(5):469-75. doi: 10.1067/mpd.2003.187.
- Background: PubMed 15753890Szefler SJ, Apter A. Advances in pediatric and adult asthma. J Allergy Clin Immunol. 2005 Mar;115(3):470-7. doi: 10.1016/j.jaci.2004.12.1123.
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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.
Andrew H. Liu, MD principal investigator
National Jewish Health
Wayne Morgan, MD, CM principal investigator
University of Arizona Health Sciences Center
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID).
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 25 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00132834, which also lists 3 linked publications.
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 25 Jan 2013.