AsthmaNCT00005281
Early Risk Predictors For Chronic Pulmonary Disease
An observational study of Asthma and Lung Diseases, Obstructive, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Asthma, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1977to Nov 1998
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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.
- Medical subject headings
- Asthma, Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1977
- Study completionNov 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005281
- Sponsor's protocol ID
- 2002
- Other IDs
- R01HL036002
- Status last verified
- Apr 2001
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Weiss ST, Ware JH. Overview of issues in the longitudinal analysis of respiratory data. Am J Respir Crit Care Med. 1996 Dec;154(6 Pt 2):S208-11. doi: 10.1164/ajrccm/154.6_Pt_2.S208. No abstract available.
PubMed 8970389Rosner B. Multivariate methods for binary longitudinal data with heterogeneous correlation over time. Stat Med. 1992 Oct-Nov;11(14-15):1915-28. doi: 10.1002/sim.4780111412.
PubMed 1480881Barr MB, Weiss ST, Segal MR, Tager IB, Speizer FE. The relationship of nasal disorders to lower respiratory tract symptoms and illness in a random sample of children. Pediatr Pulmonol. 1992 Oct;14(2):91-4. doi: 10.1002/ppul.1950140206.
PubMed 1437356Rosner B. Multivariate methods for clustered binary data with multiple subclasses, with application to binary longitudinal data. Biometrics. 1992 Sep;48(3):721-31.
PubMed 1420836Tollerud DJ, Weiss ST, Leung DY. Elevated soluble interleukin-2 receptors in young healthy cigarette smokers: lack of association with atopy or airways hyperresponsiveness. Int Arch Allergy Immunol. 1992;97(1):25-30. doi: 10.1159/000236091.
PubMed 1582694Weiss ST, Tosteson TD, Segal MR, Tager IB, Redline S, Speizer FE. Effects of asthma on pulmonary function in children. A longitudinal population-based study. Am Rev Respir Dis. 1992 Jan;145(1):58-64. doi: 10.1164/ajrccm/145.1.58.
PubMed 1731600Weiss ST. Problems in the phenotypic assessment of asthma. Clin Exp Allergy. 1995 Nov;25 Suppl 2:12-4; discussion 17-8. doi: 10.1111/j.1365-2222.1995.tb00410.x. No abstract available.
PubMed 8590331Naseem SM, Tishler PV, Tager IB, Rosner B, Speizer FE. The relationship of host factors to the pathogenesis of chronic bronchitis and obstructive airway disease: lymphoblast aryl hydrocarbon hydroxylase. Am Rev Respir Dis. 1978 Apr;117(4):647-55. doi: 10.1164/arrd.1978.117.4.647. No abstract available.
PubMed 646217Tager I, Tishler PV, Rosner B, Speizer FE, Litt M. Studies of the familial aggregation of chronic bronchitis and obstructive airways disease. Int J Epidemiol. 1978 Mar;7(1):55-62. doi: 10.1093/ije/7.1.55.
PubMed 659050Speizer FE, Tager IB. Epidemiology of chronic mucus hypersecretion and obstructive airways disease. Epidemiol Rev. 1979;1:124-42. doi: 10.1093/oxfordjournals.epirev.a036206. No abstract available.
PubMed 398264Tager IB, Weiss ST, Rosner B, Speizer FE. Effect of parental cigarette smoking on the pulmonary function of children. Am J Epidemiol. 1979 Jul;110(1):15-26. doi: 10.1093/oxfordjournals.aje.a112783.
PubMed 463860Weiss ST, Tager IB, Speizer FE, Rosner B. Persistent wheeze. Its relation to respiratory illness, cigarette smoking, and level of pulmonary function in a population sample of children. Am Rev Respir Dis. 1980 Nov;122(5):697-707. doi: 10.1164/arrd.1980.122.5.697.
PubMed 7447154Tager IB, Weiss ST, Munoz A, Rosner B, Speizer FE. Longitudinal study of the effects of maternal smoking on pulmonary function in children. N Engl J Med. 1983 Sep 22;309(12):699-703. doi: 10.1056/NEJM198309223091204.
PubMed 6888441Samet JM, Tager IB, Speizer FE. The relationship between respiratory illness in childhood and chronic air-flow obstruction in adulthood. Am Rev Respir Dis. 1983 Apr;127(4):508-23. doi: 10.1164/arrd.1983.127.4.508.
PubMed 6340572Weiss ST, Tager IB, Schenker M, Speizer FE. The health effects of involuntary smoking. Am Rev Respir Dis. 1983 Nov;128(5):933-42. doi: 10.1164/arrd.1983.128.5.933.
PubMed 6638684
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Risk Predictors For Chronic Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00005281
- Acronym / sponsor ID
- 2002
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1977
- Study completion
- Nov 1998 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Background: PubMed 8970389Weiss ST, Ware JH. Overview of issues in the longitudinal analysis of respiratory data. Am J Respir Crit Care Med. 1996 Dec;154(6 Pt 2):S208-11. doi: 10.1164/ajrccm/154.6_Pt_2.S208. No abstract available.
- Background: PubMed 1480881Rosner B. Multivariate methods for binary longitudinal data with heterogeneous correlation over time. Stat Med. 1992 Oct-Nov;11(14-15):1915-28. doi: 10.1002/sim.4780111412.
- Background: PubMed 1437356Barr MB, Weiss ST, Segal MR, Tager IB, Speizer FE. The relationship of nasal disorders to lower respiratory tract symptoms and illness in a random sample of children. Pediatr Pulmonol. 1992 Oct;14(2):91-4. doi: 10.1002/ppul.1950140206.
- Background: PubMed 1420836Rosner B. Multivariate methods for clustered binary data with multiple subclasses, with application to binary longitudinal data. Biometrics. 1992 Sep;48(3):721-31.
- Background: PubMed 1582694Tollerud DJ, Weiss ST, Leung DY. Elevated soluble interleukin-2 receptors in young healthy cigarette smokers: lack of association with atopy or airways hyperresponsiveness. Int Arch Allergy Immunol. 1992;97(1):25-30. doi: 10.1159/000236091.
- Background: PubMed 1731600Weiss ST, Tosteson TD, Segal MR, Tager IB, Redline S, Speizer FE. Effects of asthma on pulmonary function in children. A longitudinal population-based study. Am Rev Respir Dis. 1992 Jan;145(1):58-64. doi: 10.1164/ajrccm/145.1.58.
- Background: PubMed 8590331Weiss ST. Problems in the phenotypic assessment of asthma. Clin Exp Allergy. 1995 Nov;25 Suppl 2:12-4; discussion 17-8. doi: 10.1111/j.1365-2222.1995.tb00410.x. No abstract available.
- Background: PubMed 646217Naseem SM, Tishler PV, Tager IB, Rosner B, Speizer FE. The relationship of host factors to the pathogenesis of chronic bronchitis and obstructive airway disease: lymphoblast aryl hydrocarbon hydroxylase. Am Rev Respir Dis. 1978 Apr;117(4):647-55. doi: 10.1164/arrd.1978.117.4.647. No abstract available.
- Background: PubMed 659050Tager I, Tishler PV, Rosner B, Speizer FE, Litt M. Studies of the familial aggregation of chronic bronchitis and obstructive airways disease. Int J Epidemiol. 1978 Mar;7(1):55-62. doi: 10.1093/ije/7.1.55.
- Background: PubMed 398264Speizer FE, Tager IB. Epidemiology of chronic mucus hypersecretion and obstructive airways disease. Epidemiol Rev. 1979;1:124-42. doi: 10.1093/oxfordjournals.epirev.a036206. No abstract available.
- Background: PubMed 463860Tager IB, Weiss ST, Rosner B, Speizer FE. Effect of parental cigarette smoking on the pulmonary function of children. Am J Epidemiol. 1979 Jul;110(1):15-26. doi: 10.1093/oxfordjournals.aje.a112783.
- Background: PubMed 7447154Weiss ST, Tager IB, Speizer FE, Rosner B. Persistent wheeze. Its relation to respiratory illness, cigarette smoking, and level of pulmonary function in a population sample of children. Am Rev Respir Dis. 1980 Nov;122(5):697-707. doi: 10.1164/arrd.1980.122.5.697.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung Diseases, Obstructive, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005281, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.