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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital Medical Center, Cincinnati
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00395096
  Purpose

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.


Condition
Asthma

MedlinePlus related topics:   Asthma   

ChemIDplus related topics:   Nitric oxide   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Environmental Exposures, NOS Genes, and Exhaled Nitric Oxide in Pediatric Asthma

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Blood and urine


Enrollment:   225
Study Start Date:   July 2006
Estimated Study Completion Date:   July 2008

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
Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Cincinnati area children with asthma


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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395096

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center    
      Cincinnati, Ohio, United States, 45229-3039

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital Medical Center, Cincinnati

Investigators
Principal Investigator:     Adam J. Spanier, MD, MPH     Children's Hospital Medical Center, Cincinnati    
  More Information


Publications of Results:

Other Publications:

Responsible Party:   Cincinnati Children's Hospital Medical Center ( Adam Spanier )
Study ID Numbers:   1354, R21 HL083145-01A1
First Received:   October 31, 2006
Last Updated:   December 17, 2007
ClinicalTrials.gov Identifier:   NCT00395096
Health Authority:   United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Exhaled Nitric Oxide  
Asthma  
Tobacco Smoke  
Allergen  

Study placed in the following topic categories:
Nitric Oxide
Smoking
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Respiratory System Agents
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Bronchial Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on September 23, 2008




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