Clinical Trials Directory

Trials / Completed

CompletedNCT00005281

Early Risk Predictors For Chronic Pulmonary Disease

Status
Completed
Phase
Study type
Observational
Enrollment
Sponsor
National Heart, Lung, and Blood Institute (NHLBI) · NIH
Sex
Male
Age
100 Years
Healthy volunteers
Not accepted

Summary

To continue to evaluate risk factors heretofore determined to be important predictors of chronic respiratory symptoms, diagnosis of asthma, and alterations in expected levels of lung function in children and adolescents in a new population of young adult women.

Detailed description

BACKGROUND: This longitudinal study was initiated in 1975 when a stratified random sample of children, ages 5-9 years and living in the East Boston area of the City of Boston, was selected. Annual lung function tests were performed on the children and their families and questionnaires administered on respiratory illness history, smoking history, disability from cardiac disease, age of menarche in female children and demographic data such as type of heating, type of fuel for cooking, types of air purifying devices, and area of residence. A subset of the cohort had repeated measures of eucapneic hyperventilation with cold air. The cohort was also studied with helium-oxygen protocol. Analysis focused on validation of existing models, including the autoregressive model, for lung growth in children and adolescents and the decline in growth in adults. DESIGN NARRATIVE: The longitudinal study was renewed in 1995. The overall aim of this continuing investigation was to evaluate risk factors heretofore determined to be important predictors of chronic respiratory symptoms, diagnosis of asthma, and alterations in expected levels of lung function in children and adolescents in a new population of young adult women. Within the existing population the investigators had already obtained repeated observations of airways responsiveness and measures of morbidity on a group of young adults aged up to 35. These data, however, were limited in total numbers to a few hundred. They expanded the observations to 883 women aged 17-22 specifically to assess risk factors that affected maximum attained level of lung function. Data on the entire cohort were collected cross-sectionally and included standardized questionnaires on respiratory symptoms, diseases, and exposures. Pulmonary function, height, and immediate medication history were subsequently obtained on the entire cohort, along with blood specimens that were analyzed immediately for WBC and total eosinophil counts and stored for subsequent analysis of lgE and cytokine profiles. To assess the impact of a history of asthma (wheeze), all subjects reporting asthma with the use of medication in the last month, a one-third sample of women with symptoms with no medication use, and an equal number of asymptomatic age and smoking matched women had spirometry repeated before and after bronchodilator use. The results of these investigations provided insights into risk factors affecting maximum obtained level of pulmonary function in women. Since level of function is a critical determinant of risk of developing chronic obstructive lung disease, the determination of the interaction of factors other than cigarette smoking led to better strategies for helping women to stop smoking, which would be a major step in reducing morbidity and mortality from chronic respiratory disease. The study was formerly supported by R01HL22528. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Conditions

Timeline

Start date
1977-09-01
Completion
1998-11-01
First posted
2000-05-26
Last updated
2016-03-16

Source: ClinicalTrials.gov record NCT00005281. Inclusion in this directory is not an endorsement.