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Chronic Life Stress and Incident Asthma in Adult Women

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

undefined - 100 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 16, 2000
    Last Updated
    March 15, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00006498
    Brief Title
    Chronic Life Stress and Incident Asthma in Adult Women
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2000 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2005 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To prospectively examine the association between a specific chronic life stressor (i.e., intimate violence exposure) and adult asthma in women.
    Detailed Description
    BACKGROUND: Etiologies of the rising prevalence and morbidity of asthma are not well understood. Knowledge gaps are particularly significant with respect to adult-onset asthma. The role of stress in the expression of asthma is largely unexplored in large-scale, prospective, epidemiologic studies and such investigation has been identified as a priority by a recent NHLBI expert panel. DESIGN NARRATIVE: The study prospectively examines the association between a specific chronic life stressor (i.e., intimate violence exposure) and adult asthma in women participating in the Nurses' Health Study II cohort. Emerging epidemiologic data suggest that exposure to intimate violence is a pervasive chronic life stressor associated with adverse impact on womens' psychological and physical health. Traumatic stress such as that related to intimate violence exposure has been associated with neuroendocrine changes known to cause alterations in neuroendocrine and immune functions important to the pathophysiology of inflammatory diseases including asthma. The investigators are testing the hypothesis that women exposed to high-level chronic stress (violence) will be at greater risk for asthma development than women with low-level stress (violence) exposure. The influence of chronic stress on neuroendocrine and immune function as reflected in morning cortisol expression, for the former, and cytokine profiles and IgE production (T-helper cell polarization), for the latter, will also be examined in a nested case control fashion among these women. 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
    Female
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rosalind Wright
    Organizational Affiliation
    Brigham and Women's Hospital

    12. IPD Sharing Statement

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    Chronic Life Stress and Incident Asthma in Adult Women

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