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| Tracking Information | |
|---|---|
| First Received Date ICMJE | February 20, 2001 |
| Last Updated Date | March 22, 2006 |
| Start Date ICMJE | December 1998 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00011440 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Pollutant Altered Allergic Responses |
| Official Title ICMJE | Markers of Pollutant Altered Allergic Responses |
| Brief Summary | This study is designed to investigate whether exposure to particulate air pollution increases the allergic response to allergens. Research studies suggest that symptoms in individuals with allergies may be aggravated by exposure to particulate air pollution. We sought to experimental determine this by exposing human volunteers to combustion particles, a component of air pollution, and then challenge them with an allergen such as ragweed or oak tree pollen. Using biological tests we can measure whether the allergen response is magnified by prior particulate exposure. |
| Detailed Description | To study whether particulates enhance the allergic response, we chose the upper airway as a model of allergic inflammation and nasal lavage as a non-invasive method for obtaining samples. The nasal cavity is both an excellent model of allergic inflammation and provides an easily accessible site for study. We measured inflammatory cells and cytokines in the nasal lavage fluid. Our specific hypothesis was that particulate exposure prior to allergen challenge would enhance inflammatory cell recruitment and expression of inflammatory cytokines. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Natural History, Longitudinal, Random Sample, Prospective Study |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * | |
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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 | 20 |
| Completion Date | August 2002 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Adult without a history of asthma or respiratory disease. |
| Gender | Both |
| Ages | 18 Years to 60 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00011440 |
| Responsible Party | |
| Study ID Numbers ICMJE | 8077-CP-001 |
| Study Sponsor ICMJE | National Institute of Environmental Health Sciences (NIEHS) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institute of Environmental Health Sciences (NIEHS) |
| Verification Date | March 2006 |
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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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