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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005361
Other study ID # 4248
Secondary ID R01HL048619
Status Completed
Phase N/A
First received May 25, 2000
Last updated May 12, 2016
Start date April 1993
Est. completion date March 1998

Study information

Verified date June 2000
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 measure lung function and respiratory symptom status in a large cohort of healthy, non-smoking 18-22 year old subjects, and relate these measurements to past histories of passive smoke and air pollution exposures.


Description:

BACKGROUND:

While the natural history of human lung function growth and decline has been studied intensively over the past 30 years, relatively few data have been collected during the period in which peak volumetric function is achieved, i.e., around the age of 20. As a result, very little is known about the factors, both demographic and environmental, which influence maximal attained lung function.

DESIGN NARRATIVE:

The longitudinal study collected information on the history of respiratory illness, residential history, parental smoking, socio-economic status and home characteristics via an initial questionnaire administered to cadets enrolling at West Point. A sequence of four annual measurements of lung function (by spirometry), and prior-year respiratory health status and activity patterns was obtained in the spring of each year. Pollution exposures were estimated by matching residential histories with historical pollution data stored at the Environmental Protection Agency. Data on meteorological variables (temperature, relative humidity, wind speed) and altitude were obtained for each residential location. The four annual lung function measurements provided precise estimates of individual mean levels of FVC, FEV1, FEF25-75, PEFR, and flow rates at 50 percent and 75 percent of expired FVC. Subject-specific lung function level was analyzed in relation to history of parental smoking and prior exposure to air pollution using analysis of variance methods, controlling for potential confounding variables. In addition to testing these hypotheses regarding the respiratory effects of passive smoking and air pollution exposure, the study also explored the effects of these exposures on the change in lung function between the ages of 18 and 22 and on respiratory illness and symptom experience while at West Point. Finally, the study established a cohort which could be followed in future years.

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 1998
Est. primary completion date
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


Locations

Country Name City State
n/a

Sponsors (1)

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

References & Publications (1)

Kinney PL, Nilsen DM, Lippmann M, Brescia M, Gordon T, McGovern T, El-Fawal H, Devlin RB, Rom WN. Biomarkers of lung inflammation in recreational joggers exposed to ozone. Am J Respir Crit Care Med. 1996 Nov;154(5):1430-5. — View Citation

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