Lung Diseases, ObstructiveNCT00006513
Assessing the Occupation Burden in COPD
An observational study of Lung Diseases, Obstructive and Chronic Obstructive Pulmonary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To assess the population burden of occupational exposures in the prevalence and progression of chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2000to Aug 2004
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
No eligibility criteria
About this study
To assess the population burden of occupational exposures in the prevalence and progression of chronic obstructive pulmonary disease (COPD).
Read the detailed description
BACKGROUND:
Chronic obstructive pulmonary disease is the only one of the top four or five leading causes of death in the U.S. with worsening epidemiological trends. Cigarette smoking accounts for approximately 85 percent-90 percent of cases, but the other 10 percent-15 percent of the attributable risk still represents a substantial fraction of this disease that remains unexplained. Recently, several studies, in various countries, have addressed whether certain occupational exposures (primarily those relating to dusts, vapors, gases, and/or fumes) are potential risk factors for COPD. Most of these studies have shown elevated odds ratios or relative risks, although not always to a statistically significant level.
DESIGN NARRATIVE:
A population sample of the continental United States of those aged 55-75, supplemented by an enriched sample in geographic "hot spots" identified by the National Institute for Occupational Safety and Health (NIOSH) through respiratory diseases mapping. Structured telephone interviews assessed demographics, health status, smoking exposures, and occupational histories. High risk jobs were coded using a job matrix system independent of subject report of specific exposures. Two hundred thirty-four of those with COPD, with over-sampling of those with greater severity, were followed at 12-14 months to assess health status and health services utilization, as well as decrements in quality of life.
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
- 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 posted21 Nov 2000 (estimated)
- Study startSep 2000
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung Diseases, ObstructiveStudies 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
- Investigators
- Paul Blanc, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006513
- Sponsor's protocol ID
- 949
- Other IDs
- R01HL067438
- Status last verified
- Jan 2006
- First submitted
- 20 Nov 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Trupin L, Earnest G, San Pedro M, Balmes JR, Eisner MD, Yelin E, Katz PP, Blanc PD. The occupational burden of chronic obstructive pulmonary disease. Eur Respir J. 2003 Sep;22(3):462-9. doi: 10.1183/09031936.03.00094203.
PubMed 14516136Blanc PD, Eisner MD, Trupin L, Yelin EH, Katz PP, Balmes JR. The association between occupational factors and adverse health outcomes in chronic obstructive pulmonary disease. Occup Environ Med. 2004 Aug;61(8):661-7. doi: 10.1136/oem.2003.010058.
PubMed 15258271
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
- Assessing the Occupation Burden in COPD
- ClinicalTrials.gov ID
- NCT00006513
- Acronym / sponsor ID
- 949
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 2000
- Study completion
- Aug 2004 (actual)
- First posted
- 21 Nov 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 assess the population burden of occupational exposures in the prevalence and progression of chronic obstructive pulmonary disease (COPD).
Detailed description
BACKGROUND:
Chronic obstructive pulmonary disease is the only one of the top four or five leading causes of death in the U.S. with worsening epidemiological trends. Cigarette smoking accounts for approximately 85 percent-90 percent of cases, but the other 10 percent-15 percent of the attributable risk still represents a substantial fraction of this disease that remains unexplained. Recently, several studies, in various countries, have addressed whether certain occupational exposures (primarily those relating to dusts, vapors, gases, and/or fumes) are potential risk factors for COPD. Most of these studies have shown elevated odds ratios or relative risks, although not always to a statistically significant level.
DESIGN NARRATIVE:
A population sample of the continental United States of those aged 55-75, supplemented by an enriched sample in geographic "hot spots" identified by the National Institute for Occupational Safety and Health (NIOSH) through respiratory diseases mapping. Structured telephone interviews assessed demographics, health status, smoking exposures, and occupational histories. High risk jobs were coded using a job matrix system independent of subject report of specific exposures. Two hundred thirty-four of those with COPD, with over-sampling of those with greater severity, were followed at 12-14 months to assess health status and health services utilization, as well as decrements in quality of life.
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
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 14516136Trupin L, Earnest G, San Pedro M, Balmes JR, Eisner MD, Yelin E, Katz PP, Blanc PD. The occupational burden of chronic obstructive pulmonary disease. Eur Respir J. 2003 Sep;22(3):462-9. doi: 10.1183/09031936.03.00094203.
- Background: PubMed 15258271Blanc PD, Eisner MD, Trupin L, Yelin EH, Katz PP, Balmes JR. The association between occupational factors and adverse health outcomes in chronic obstructive pulmonary disease. Occup Environ Med. 2004 Aug;61(8):661-7. doi: 10.1136/oem.2003.010058.
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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.
Paul Blanc
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, Obstructive and Chronic Obstructive Pulmonary Disease, 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 NCT00006513, which also lists 2 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.