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| Descriptive Information Fields | |||||
| Brief Title † | Exploration Of Key Targets And Biomarkers Involved In An Allergic Response In Subjects With Allergic Rhinitis (Hay Fever) | ||||
| Official Title † | A Study to Validate Key Therapeutic Targets and Biomarkers During Allergen Exposure in Subjects With Allergic Rhinitis | ||||
| Brief Summary | This study is aimed at validating key therapeutic targets and biomarkers associated with allergic rhinitis. The therapeutic target expression will be investigated after a 7 day course of corticosteroid treatment followed by allergen challenge. |
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Diagnostic, Randomized, Double-Blind, Crossover Assignment, Pharmacodynamics Study | ||||
| Primary Outcome Measure † | Change in expression of key allergy targets in the nose following exposure to allergen. Assessment of protein expression measured by western blotting and immunohistochemistry in nasal biopsy tissue. | ||||
| Secondary Outcome Measure † | Effect of corticosteroids treatment on the change in target expression following allergen challenge. Nasal lavage fluid and nasal secretions will be measured by ELISA and chemiluminescent assay. | ||||
| Condition † | Allergic Rhinitis | ||||
| Intervention † | Drug: Fluticasone Propionate | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 48 | ||||
| Start Date † | April 2005 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Netherlands, United Kingdom | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00348361 | ||||
| Organization ID | ELR100710 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | GlaxoSmithKline | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | October 2008 | ||||
| First Received Date † | June 30, 2006 | ||||
| Last Updated Date | October 9, 2008 | ||||