Environmental Exposures, Genetics, and Exhaled Nitric Oxide in Pediatric Asthma

Asthma Clinical Trial

Official title:

Environmental Exposures, NOS Genes, and Exhaled Nitric Oxide in Pediatric Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395096
• Other study ID #: 1354
• Secondary ID: R21HL083145R21HL
• Status: Completed
• Start date: July 2006
• Est. completion date: June 2008

Study information

• Verified date: February 2009
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of environmental and genetic factors on exhaled nitric oxide (eNO) levels and the relationship between eNO and asthma severity		Measured through the use of data previously collected in the Cincinnati Asthma Prevention (CAP) study