AsthmaNCT00005755
Community Based Study on Occupational Asthma
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To examine the occupations, industries and exposures in the work-place which were associated with a high risk for asthma and other adverse respiratory health effects, with particular emphasis on specific exposures of predominantly female occupations (irritants, detergents and other asthmagens), and of other high risk… Read more about this study
- Who is it for?
- Ages 20 to 44 years
- Conditions the study is for
- Asthma, Lung Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 1999to Apr 2003
- 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 20 to 44 years
- All sexes
- No healthy volunteers
- Adult
No eligibility criteria
About this study
To examine the occupations, industries and exposures in the work-place which were associated with a high risk for asthma and other adverse respiratory health effects, with particular emphasis on specific exposures of predominantly female occupations (irritants, detergents and other asthmagens), and of other high risk major occupations which had not been adequately examined.
Read the detailed description
BACKGROUND:
Respiratory diseases are strongly related with exposure in the workplace. A considerable proportion of adult onset asthma is associated with these exposures. The importance of occupational risk factors for asthma has been underestimated, particularly among women. The occupational asthma study (ECRHS-OA) forms part of a wider international multicentre survey on respiratory health (European Community Respiratory Health Survey-ECRHS). The first phase of the ECRHS was conducted in 1991/92 and examined risk factors for asthma and atopy in subjects aged 20-44 years. The study updated (ECRHS-II), following-up approximately 17,000 young adults from 12 countries (Australia, Belgium, France, Germany, Iceland, Italy, Norway, Spain, Sweden, Switzerland, UK and USA).
The study provided valid and precise estimates on the importance of specific occupations, industries and exposures in relation to asthma incidence and prevalence, similar estimates for other respiratory symptoms and diseases and also for declines in pulmonary function.
DESIGN NARRATIVE:
Longitudinal, community-based, multicenter study. Those subjects who took part in the first occupational asthma study survey were re-contacted in 1999, to determine risk factors for incidence and remission of asthma, other respiratory symptoms, atopy, changes in bronchial responsiveness and lung function. Subjects were asked to perform a forced spirometry, methacholine challenge and to provide blood samples for IgE testing. A questionnaire administrated by trained interviewers was delivered requesting information on respiratory symptoms and diseases, socio-demographic factors, tobacco smoking, complete occupational history since the last survey, environmental exposures, family history, diet, treatment and use of health services. Modular occupational questionnaires were developed for subjects employed as cleaners, homemakers, welders, metal workers, nurses, and subjects exposed to organic dusts in the paper and textile industries.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Asthma, Lung Diseases
- Medical subject headings
- Asthma, Lung Diseases
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 startMay 1999
- Study completionApr 2003
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
- Investigators
- Manolis Kogevinas, Municipal Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005755
- Sponsor's protocol ID
- 5109
- Other IDs
- R01HL062633
- Status last verified
- Jan 2006
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Zock JP, Kogevinas M, Sunyer J, Almar E, Muniozguren N, Payo F, Sanchez JL, Anto JM; Spanish working group of the European Community Respiratory Health Survey. Asthma risk, cleaning activities and use of specific cleaning products among Spanish indoor cleaners. Scand J Work Environ Health. 2001 Feb;27(1):76-81. doi: 10.5271/sjweh.590.
PubMed 11266151Zock JP, Kogevinas M, Sunyer J, Jarvis D, Toren K, Anto JM; European Community Respiratory Health Survey. Asthma characteristics in cleaning workers, workers in other risk jobs and office workers. Eur Respir J. 2002 Sep;20(3):679-85. doi: 10.1183/09031936.02.00279702.
PubMed 12358347Zock JP, Cavalle N, Kromhout H, Kennedy SM, Sunyer J, Jaen A, Muniozguren N, Payo F, Almar E, Sanchez JL, Anto JM, Kogevinas M. Evaluation of specific occupational asthma risks in a community-based study with special reference to single and multiple exposures. J Expo Anal Environ Epidemiol. 2004 Sep;14(5):397-403. doi: 10.1038/sj.jea.7500337.
PubMed 15361899de Vocht F, Zock JP, Kromhout H, Sunyer J, Anto JM, Burney P, Kogevinas M. Comparison of self-reported occupational exposure with a job exposure matrix in an international community-based study on asthma. Am J Ind Med. 2005 May;47(5):434-42. doi: 10.1002/ajim.20154.
PubMed 15828067
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
- Community Based Study on Occupational Asthma
- ClinicalTrials.gov ID
- NCT00005755
- Acronym / sponsor ID
- 5109
- Conditions
- Asthma, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- May 1999
- Study completion
- Apr 2003 (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 examine the occupations, industries and exposures in the work-place which were associated with a high risk for asthma and other adverse respiratory health effects, with particular emphasis on specific exposures of predominantly female occupations (irritants, detergents and other asthmagens), and of other high risk major occupations which had not been adequately examined.
Detailed description
BACKGROUND:
Respiratory diseases are strongly related with exposure in the workplace. A considerable proportion of adult onset asthma is associated with these exposures. The importance of occupational risk factors for asthma has been underestimated, particularly among women. The occupational asthma study (ECRHS-OA) forms part of a wider international multicentre survey on respiratory health (European Community Respiratory Health Survey-ECRHS). The first phase of the ECRHS was conducted in 1991/92 and examined risk factors for asthma and atopy in subjects aged 20-44 years. The study updated (ECRHS-II), following-up approximately 17,000 young adults from 12 countries (Australia, Belgium, France, Germany, Iceland, Italy, Norway, Spain, Sweden, Switzerland, UK and USA).
The study provided valid and precise estimates on the importance of specific occupations, industries and exposures in relation to asthma incidence and prevalence, similar estimates for other respiratory symptoms and diseases and also for declines in pulmonary function.
DESIGN NARRATIVE:
Longitudinal, community-based, multicenter study. Those subjects who took part in the first occupational asthma study survey were re-contacted in 1999, to determine risk factors for incidence and remission of asthma, other respiratory symptoms, atopy, changes in bronchial responsiveness and lung function. Subjects were asked to perform a forced spirometry, methacholine challenge and to provide blood samples for IgE testing. A questionnaire administrated by trained interviewers was delivered requesting information on respiratory symptoms and diseases, socio-demographic factors, tobacco smoking, complete occupational history since the last survey, environmental exposures, family history, diet, treatment and use of health services. Modular occupational questionnaires were developed for subjects employed as cleaners, homemakers, welders, metal workers, nurses, and subjects exposed to organic dusts in the paper and textile industries.
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
- 20 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 11266151Zock JP, Kogevinas M, Sunyer J, Almar E, Muniozguren N, Payo F, Sanchez JL, Anto JM; Spanish working group of the European Community Respiratory Health Survey. Asthma risk, cleaning activities and use of specific cleaning products among Spanish indoor cleaners. Scand J Work Environ Health. 2001 Feb;27(1):76-81. doi: 10.5271/sjweh.590.
- Background: PubMed 12358347Zock JP, Kogevinas M, Sunyer J, Jarvis D, Toren K, Anto JM; European Community Respiratory Health Survey. Asthma characteristics in cleaning workers, workers in other risk jobs and office workers. Eur Respir J. 2002 Sep;20(3):679-85. doi: 10.1183/09031936.02.00279702.
- Background: PubMed 15361899Zock JP, Cavalle N, Kromhout H, Kennedy SM, Sunyer J, Jaen A, Muniozguren N, Payo F, Almar E, Sanchez JL, Anto JM, Kogevinas M. Evaluation of specific occupational asthma risks in a community-based study with special reference to single and multiple exposures. J Expo Anal Environ Epidemiol. 2004 Sep;14(5):397-403. doi: 10.1038/sj.jea.7500337.
- Background: PubMed 15828067de Vocht F, Zock JP, Kromhout H, Sunyer J, Anto JM, Burney P, Kogevinas M. Comparison of self-reported occupational exposure with a job exposure matrix in an international community-based study on asthma. Am J Ind Med. 2005 May;47(5):434-42. doi: 10.1002/ajim.20154.
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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.
Manolis Kogevinas
Municipal Institute of Medical Research
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung Diseases, 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 NCT00005755, 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.