AsthmaNCT00395096
Environmental Exposures, Genetics, and Exhaled Nitric Oxide in Pediatric Asthma
An observational study of Asthma, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Asthma is one of the most common childhood diseases. It is chronic and often severely disabling. The amount of nitric oxide that is exhaled while breathing increases with airway inflammation, a symptom of asthma. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Asthma
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jun 2008
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Cincinnati area children with asthma
Who may be able to join
- Participated in the Cincinnati Asthma Prevention Study
- Diagnosis of asthma
- Lives with someone that smokes at least 5 cigarettes a day
Who cannot join
- No additional neuromuscular or respiratory disorder that may interfere with safe participation in the parent study
- Does not have electricity
- Plans to move within 1 year of entry into the parent study
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
About this study
Official title: Environmental Exposures, NOS Genes, and Exhaled Nitric Oxide in Pediatric Asthma
Asthma is one of the most common childhood diseases. It is chronic and often severely disabling. The amount of nitric oxide that is exhaled while breathing increases with airway inflammation, a symptom of asthma. This study will examine the results from a previous study, the Cincinnati Asthma Prevention (CAP) study, to evaluate the effects of environmental and genetic factors on exhaled nitric oxide (eNO) levels and to determine the relationship between eNO and asthma severity.
Read the detailed description
Nitric oxide is a naturally occurring gas that plays a role in many body functions. Levels of eNO increase with airway inflammation, a symptom of asthma. Researchers have proposed using eNO as a noninvasive measure to guide physicians in the treatment and medical management of asthma in children. However, more information about eNO is needed before this can happen. This study will perform a secondary analysis of the results from its parent study, the CAP study, which evaluated the effectiveness of preventing asthma in children who had been exposed to environmental tobacco smoke.
This study will not enroll any new participants. Previously collected data from the CAP study will be reevaluated in this study to determine the longitudinal effects of environmental and genetic factors on eNO levels. In addition, the data will be evaluated to determine the relationship between eNO levels and asthma severity. No new data will be collected in this study.
- Conditions
- Asthma
- Keywords
- Exhaled Nitric Oxide, Asthma, Tobacco Smoke, Allergen
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of environmental and genetic factors on exhaled nitric oxide (eNO) levels and the relationship between eNO and asthma severity
Measured: Measured through the use of data previously collected in the Cincinnati Asthma Prevention (CAP) study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startJul 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Adam J. Spanier, MD, MPH, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395096
- Sponsor's protocol ID
- 1354
- Other IDs
- R21HL083145, R21HL083145-01A1
- Status last verified
- Feb 2009
- First submitted
- 31 Oct 2006
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Spanier AJ, Hornung R, Lierl M, Lanphear BP. Environmental exposures and exhaled nitric oxide in children with asthma. J Pediatr. 2006 Aug;149(2):220-6. doi: 10.1016/j.jpeds.2006.04.001.
PubMed 16887438Wilson SE, Kahn RS, Khoury J, Lanphear BP. Racial differences in exposure to environmental tobacco smoke among children. Environ Health Perspect. 2005 Mar;113(3):362-7. doi: 10.1289/ehp.7379.
PubMed 15743729
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Exposures, NOS Genes, and Exhaled Nitric Oxide in Pediatric Asthma
- ClinicalTrials.gov ID
- NCT00395096
- Acronym / sponsor ID
- 1354
- Conditions
- Asthma
- Keywords
- Exhaled Nitric Oxide, Asthma, Tobacco Smoke, Allergen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 2 Nov 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.
Asthma is one of the most common childhood diseases. It is chronic and often severely disabling. The amount of nitric oxide that is exhaled while breathing increases with airway inflammation, a symptom of asthma. This study will examine the results from a previous study, the Cincinnati Asthma Prevention (CAP) study, to evaluate the effects of environmental and genetic factors on exhaled nitric oxide (eNO) levels and to determine the relationship between eNO and asthma severity.
Detailed description
Nitric oxide is a naturally occurring gas that plays a role in many body functions. Levels of eNO increase with airway inflammation, a symptom of asthma. Researchers have proposed using eNO as a noninvasive measure to guide physicians in the treatment and medical management of asthma in children. However, more information about eNO is needed before this can happen. This study will perform a secondary analysis of the results from its parent study, the CAP study, which evaluated the effectiveness of preventing asthma in children who had been exposed to environmental tobacco smoke.
This study will not enroll any new participants. Previously collected data from the CAP study will be reevaluated in this study to determine the longitudinal effects of environmental and genetic factors on eNO levels. In addition, the data will be evaluated to determine the relationship between eNO levels and asthma severity. No new data will be collected in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Cincinnati area children with asthma
Key inclusion criteria (3 listed)
- Participated in the Cincinnati Asthma Prevention Study
- Diagnosis of asthma
- Lives with someone that smokes at least 5 cigarettes a day
Key exclusion criteria (3 listed)
- No additional neuromuscular or respiratory disorder that may interfere with safe participation in the parent study
- Does not have electricity
- Plans to move within 1 year of entry into the parent study
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
Effects of environmental and genetic factors on exhaled nitric oxide (eNO) levels and the relationship between eNO and asthma severity
Time frame: Measured through the use of data previously collected in the Cincinnati Asthma Prevention (CAP) study
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 9 Aug 2021.
- Background: PubMed 16887438Spanier AJ, Hornung R, Lierl M, Lanphear BP. Environmental exposures and exhaled nitric oxide in children with asthma. J Pediatr. 2006 Aug;149(2):220-6. doi: 10.1016/j.jpeds.2006.04.001.
- Results publication: PubMed 15743729Wilson SE, Kahn RS, Khoury J, Lanphear BP. Racial differences in exposure to environmental tobacco smoke among children. Environ Health Perspect. 2005 Mar;113(3):362-7. doi: 10.1289/ehp.7379.
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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.
Adam J. Spanier, MD, MPH principal investigator
Children's Hospital Medical Center, Cincinnati
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 Children's Hospital Medical Center, Cincinnati 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 3 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: finished, as of the sponsor's last update on 9 Aug 2021. 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?
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.
What does the primary outcome measure?
Effects of environmental and genetic factors on exhaled nitric oxide (eNO) levels and the relationship between eNO and asthma severity (time frame: Measured through the use of data previously collected in the Cincinnati Asthma Prevention (CAP) study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00395096, which also lists 2 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 9 Aug 2021.