Chronic Obstructive Pulmonary Disease Clinical Trial
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.
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.
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