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Exposure of Children With Asthma to Household Environmental Tobacco Smoke

Primary Purpose

Asthma, Lung Diseases

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Asthma

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 4, 2002
    Last Updated
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00035685
    Brief Title
    Exposure of Children With Asthma to Household Environmental Tobacco Smoke
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To examine whether or not primary school-aged children with asthma from low-income households have lower household environmental tobacco smoke (ETS) exposure than matched control children.
    Detailed Description
    BACKGROUND: Children with asthma are particularly vulnerable to environmental tobacco smoke (ETS). However, despite this special vulnerability to ETS, children with asthma are at least as likely to live in smoking households, as are healthy children. Controversy exists, however, about whether or not the smoking members of households with children with asthma use specific strategies to reduce the harmful effects of their smoking on their children more than the smoking members of households of healthy children. DESIGN NARRATIVE: The case-control study examines whether or not primary school-aged children with asthma from low-income households have lower household ETS exposure than matched control children. Household ETS exposure will be measured by both objective monitoring, specifically passive nicotine dosimeters and child cotinine assays (the primary hypothesis), and maternal-report (the secondary hypothesis). Ninety children with physician diagnosed asthma and smoking mothers will be matched by age, gender, race/ethnicity, and other relevant variables to 90 healthy children. All children will be recruited from Metro Denver clinics providing services to low-income, underserved populations. The sample will contain equal numbers of African Americans, Hispanics, and Whites. Recruitment will target low-income populations due to their increased prevalence of, and associated morbidity from both asthma and tobacco smoking. Specific household smoking behaviors, as reported by mothers, will be examined for association with household nicotine and child cotinine levels. Finally, a set of carefully chosen measures will be examined in tertiary, exploratory analyses to help understand, clarify, and contextualize the observed results. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma, Lung Diseases

    7. Study Design

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frederick Walboldt
    Organizational Affiliation
    National Jewish Medical & Research Center

    12. IPD Sharing Statement

    Learn more about this trial

    Exposure of Children With Asthma to Household Environmental Tobacco Smoke

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