Early Risk Predictors For Chronic Pulmonary Disease

March 15, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1977

Study Completion (Actual)

November 1, 1998

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

April 1, 2001

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2002
  • R01HL036002 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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