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

August 3, 2021 updated by: Children's Hospital Medical Center, Cincinnati

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cincinnati area children with asthma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Measured through the use of data previously collected in the Cincinnati Asthma Prevention (CAP) study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

October 31, 2006

First Submitted That Met QC Criteria

October 31, 2006

First Posted (Estimate)

November 2, 2006

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1354
  • R21HL083145 (U.S. NIH Grant/Contract)
  • R21HL083145-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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