Clinical trial NCT00395096: Environmental Exposures, Genetics, and Exhaled Nitric Oxide in Pediatric Asthma
Official title: Environmental Exposures, NOS Genes, and Exhaled Nitric Oxide in Pediatric Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Exhaled Nitric Oxide
Asthma
Tobacco Smoke
Allergen
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2006-11-02
Enrollment: 225
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cincinnati area children with asthma

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Participated in the Cincinnati Asthma Prevention Study
* Diagnosis of asthma
* Lives with someone that smokes at least 5 cigarettes a day

Exclusion Criteria:

* 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

Primary outcomes:
measure: Effects of environmental and genetic factors on exhaled nitric oxide (eNO) levels and the relationship between eNO and asthma severity
timeFrame: Measured through the use of data previously collected in the Cincinnati Asthma Prevention (CAP) study
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Adam J. Spanier, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Wilson 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.