Longitudinal Study of Cortisol and Pulmonary Function

Chronic Obstructive Pulmonary Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005370
• Other study ID #: 4261
• Secondary ID: R01HL049869
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: May 12, 2016
• Start date: April 1993
• Est. completion date: March 1999

Study information

• Verified date: November 2001
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)