Longitudinal Study of Cortisol and Pulmonary Function - Tabular View

Tracking Information
First Received Date ^ICMJE	May 25, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE	April 1993
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00005370 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Longitudinal Study of Cortisol and Pulmonary Function
Official Title ^ICMJE
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.
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Natural History
Condition ^ICMJE	Lung Diseases, Obstructive Chronic Obstructive Pulmonary Disease
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	March 1999
Primary Completion Date
Eligibility Criteria ^ICMJE	No eligibility criteria
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00005370
Responsible Party
Study ID Numbers ^ICMJE	4261
Study Sponsor ^ICMJE	National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Heart, Lung, and Blood Institute (NHLBI)
Verification Date	November 2001
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP