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| Tracking Information | |||||
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| First Received Date ICMJE | May 25, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | February 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00005544 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Community Based Study of Adult Onset Asthma | ||||
| Official Title ICMJE | |||||
| Brief Summary | To identify the role of irritant exposure in adult-onset asthma by simultaneously using both clinical and case control methods in a community-based perspective study of asthma incidence. |
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| Detailed Description | BACKGROUND: Asthma incidence is increasing, and in adults work-related exposures may be an important factor-occupational asthma (OA) incidence increased 70 percent over the last decade according to a recent registry based study. The true contribution of occupational exposures to adult-onset asthma is unknown because the methods for measuring OA give conflicting results. Methods based on surveillance of clinically diagnosed OA account for less than one to five percent of adult-onset asthma. However, case-control methods of measuring asthma risk by industry suggest that six to 33 percent of adult-onset asthma is caused by workplace exposures. The conflict may occur because of two factors: physicians often fail to diagnose and report OA, and irritant exposures may increase the risk the risk of asthma without causing cases that meet the clinical definition. Both factors have important implications for proper treatment and prevention of asthma in adults. DESIGN NARRATIVE: Clinical and case control methods were used to identify the role of irritant exposure in adult-onset asthma in a community-based prospective study of asthma incidence. The study cohort was a typical US working population enrolled in an HMO. Additional benefits of the study design were the opportunities to validate a questionnaire for exposure assessment and for detection of work-related asthma. Specifically, the study: 1) Investigated incident cases in a cohort of over 80,000 adults over three years and determined the proportion that met a clinical definition of occupational asthma (OA); 2) Used a nested case-control study to determine the incidence of all asthma by occupation and workplace exposure; 3) Determined whether clinical OA accounted for the excess incidence of adult-onset asthma associated with workplace exposure to sensitizers and irritants; 4) Prospectively followed asthmatics for two years after diagnosis to determine the impact of adult-onset asthma on lung function, employment, income, and quality of life, and to determine whether prognosis differed for clinical OA and for asthma associated with workplace irritant exposure; 5) Tested an intervention designed to increase appropriate clinical diagnosis, and thus secondary prevention of OA. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Natural History, Defined Population | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | Sama SR, Hunt PR, Cirillo CP, Marx A, Rosiello RA, Henneberger PK, Milton DK. A longitudinal study of adult-onset asthma incidence among HMO members. Environ Health. 2003 Aug 07;2(1):10. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | January 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00005544 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 5087 | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | May 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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