Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005281
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-05-25
Brief Title:
Early Risk Predictors For Chronic Pulmonary Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL036002 | NIH | None | httpsreporternihgovquickSearchR01HL036002 |