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

This study has been completed.
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00395096
First received: October 31, 2006
Last updated: February 17, 2009
Last verified: February 2009
  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

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

Resource links provided by NLM:


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

Blood and urine


Enrollment: 225
Study Start Date: July 2006
Study Completion Date: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Adam Spanier, Cincinnati Children's Hospital Medical Center
ClinicalTrials.gov Identifier: NCT00395096     History of Changes
Other Study ID Numbers: 1354, R21 HL083145-01A1
Study First Received: October 31, 2006
Last Updated: February 17, 2009
Health Authority: United States: Federal Government

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
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Gasotransmitters
Protective Agents

ClinicalTrials.gov processed this record on September 16, 2014