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Longitudinal Study of Cortisol and Pulmonary Function

Primary Purpose

Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease

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 Lung Diseases, Obstructive

Eligibility Criteria

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

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    May 12, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005370
    Brief Title
    Longitudinal Study of Cortisol and Pulmonary Function
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    November 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1993 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 1999 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To conduct a longitudinal study of the relationship between the rate of decline of pulmonary function and measurements of cortisol concentration and excretion in a sample of middle-aged and older men and their wives. The study tested the hypothesis that persons whose plasma cortisol concentrations were relatively low, albeit within the normal range, were predisposed to excessively rapid deterioration of pulmonary function during aging.
    Detailed Description
    BACKGROUND: It was hoped that the study would provide important insights into the pathogenesis of chronic obstructive pulmonary disease with potential implications for prevention and early therapeutic intervention. DESIGN NARRATIVE: All subjects participating in the Normative Aging Study were recruited for the study at the time of their next scheduled examination. Twenty-four hour urinary excretion of free cortisol, morning serum cortisol concentration, and pre- and post-bronchodilator spirometric indices were measured. For the 700 subjects who were recruited during years one and two of the study, these measurements were repeated when subjects returned for their next triennial examination in years four and five of the study. Respiratory illness and smoking questionnaire data, total and differential leukocyte counts, and methacholine inhalation challenge test data were also available at both time points. The specific aims of the study were to examine: (1) the cross-sectional relationship between level of pulmonary function and both morning serum cortisol concentration and 24-hour urinary free cortisol excretion; (2) the relationship between the rate of decline of pulmonary function during the follow-up interval and these measurements of cortisol concentration and excretion; (3) whether these relationships were modified by smoking history, blood total leukocyte count, methacholine airway responsiveness, or other characteristics; and (4) the stability over time of serum cortisol concentration and urinary cortisol excretion in this aging population. 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
    Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease

    7. Study Design

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

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    Longitudinal Study of Cortisol and Pulmonary Function

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