AsthmaNCT00005425
Statistical Analysis of Vlagtwedde-Vlaardingen Data Set
An observational study of Asthma and Lung Diseases, Obstructive, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the effects in early adulthood of asthma, increased bronchial responsiveness, markers of allergy and smoking on pulmonary function level and the effects of these same risk factors on subsequent decline in pulmonary function, because these early adult factors presumably profoundly influence the risk for… 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 1992to Feb 1995
- 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 determine the effects in early adulthood of asthma, increased bronchial responsiveness, markers of allergy and smoking on pulmonary function level and the effects of these same risk factors on subsequent decline in pulmonary function, because these early adult factors presumably profoundly influence the risk for chronic obstructive pulmonary disease.
Read the detailed description
DESIGN NARRATIVE:
The questions studied included whether the above named risk factors reduced the maximally attained level of pulmonary function in early adulthood, foreshortened the postulated stability of level of pulmonary function between age 18 and 35 and/or unfavorably affected subsequent decline in level of pulmonary function. FEV1/h2, VC/h2 and FEV1/IVC were studied, using graphic smooth techniques and regression analyses techniques on both cross-sectional and longitudinal datasets. In addition, the investigators tested the hypothesis stating that early adult symptoms of asthma, increased bronchial responsiveness, markers of allergy influenced who became a smoker, influenced the amount smoked and/or influenced who stopped smoking relatively early in adult life, using logistic regression analyses and survival analyses.
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 1992
- Study completionFeb 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- NCT00005425
- Sponsor's protocol ID
- 4343
- Other IDs
- R03HL049460
- Status last verified
- Apr 2001
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Shimada M, Matsumata T, Itasaka H, Shirabe K, Taketomi A, Sugimachi K. The prediction of portal pressure: a multivariate analysis of clinical data and intraoperative portal pressure. Surg Today. 1994;24(4):309-12. doi: 10.1007/BF02348558.
PubMed 8038504Xu X, Weiss ST, Dockery DW, Schouten JP, Rijcken B. Comparing FEV1 in adults in two community-based studies. Chest. 1995 Sep;108(3):656-62. doi: 10.1378/chest.108.3.656.
PubMed 7656612Rijcken B, Schouten JP, Xu X, Rosner B, Weiss ST. Airway hyperresponsiveness to histamine associated with accelerated decline in FEV1. Am J Respir Crit Care Med. 1995 May;151(5):1377-82. doi: 10.1164/ajrccm.151.5.7735588.
PubMed 7735588Xu X, Laird N, Dockery DW, Schouten JP, Rijcken B, Weiss ST. Age, period, and cohort effects on pulmonary function in a 24-year longitudinal study. Am J Epidemiol. 1995 Mar 15;141(6):554-66. doi: 10.1093/oxfordjournals.aje.a117471.
PubMed 7900723
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
- Statistical Analysis of Vlagtwedde-Vlaardingen Data Set
- ClinicalTrials.gov ID
- NCT00005425
- Acronym / sponsor ID
- 4343
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1992
- Study completion
- Feb 1995 (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 determine the effects in early adulthood of asthma, increased bronchial responsiveness, markers of allergy and smoking on pulmonary function level and the effects of these same risk factors on subsequent decline in pulmonary function, because these early adult factors presumably profoundly influence the risk for chronic obstructive pulmonary disease.
Detailed description
DESIGN NARRATIVE:
The questions studied included whether the above named risk factors reduced the maximally attained level of pulmonary function in early adulthood, foreshortened the postulated stability of level of pulmonary function between age 18 and 35 and/or unfavorably affected subsequent decline in level of pulmonary function. FEV1/h2, VC/h2 and FEV1/IVC were studied, using graphic smooth techniques and regression analyses techniques on both cross-sectional and longitudinal datasets. In addition, the investigators tested the hypothesis stating that early adult symptoms of asthma, increased bronchial responsiveness, markers of allergy influenced who became a smoker, influenced the amount smoked and/or influenced who stopped smoking relatively early in adult life, using logistic regression analyses and survival analyses.
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 8038504Shimada M, Matsumata T, Itasaka H, Shirabe K, Taketomi A, Sugimachi K. The prediction of portal pressure: a multivariate analysis of clinical data and intraoperative portal pressure. Surg Today. 1994;24(4):309-12. doi: 10.1007/BF02348558.
- Background: PubMed 7656612Xu X, Weiss ST, Dockery DW, Schouten JP, Rijcken B. Comparing FEV1 in adults in two community-based studies. Chest. 1995 Sep;108(3):656-62. doi: 10.1378/chest.108.3.656.
- Background: PubMed 7735588Rijcken B, Schouten JP, Xu X, Rosner B, Weiss ST. Airway hyperresponsiveness to histamine associated with accelerated decline in FEV1. Am J Respir Crit Care Med. 1995 May;151(5):1377-82. doi: 10.1164/ajrccm.151.5.7735588.
- Background: PubMed 7900723Xu X, Laird N, Dockery DW, Schouten JP, Rijcken B, Weiss ST. Age, period, and cohort effects on pulmonary function in a 24-year longitudinal study. Am J Epidemiol. 1995 Mar 15;141(6):554-66. doi: 10.1093/oxfordjournals.aje.a117471.
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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 NCT00005425, which also lists 4 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.