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

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ClinicalTrials.gov Identifier: NCT00395096
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : February 19, 2009
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

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.

Condition or disease
Asthma

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 Type : Observational
Actual Enrollment : 225 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Environmental Exposures, NOS Genes, and Exhaled Nitric Oxide in Pediatric Asthma
Study Start Date : July 2006
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma




Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
Blood and urine


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Other Publications:
Responsible Party: Adam Spanier, Cincinnati Children's Hospital Medical Center
ClinicalTrials.gov Identifier: NCT00395096     History of Changes
Other Study ID Numbers: 1354
R21HL083145-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 2, 2006    Key Record Dates
Last Update Posted: February 19, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents