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| Tracking Information | |||||
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| First Received Date ICMJE | November 15, 2006 | ||||
| Last Updated Date | October 27, 2008 | ||||
| Start Date ICMJE | March 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00400998 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study To Validate The Vienna Challenge Chamber, In And Out Of Hayfever Season, And Also A Park Study | ||||
| Official Title ICMJE | See Detailed Description | ||||
| Brief Summary | The aim of the study is to investigate the trial models, Vienna Challenge Chamber (VCC), in and out of season, and Park Study in season and the clinical efficacy of repeat doses of fluticasone propionate in subjects with seasonal allergic rhinitis. This will be a single-centre, randomised, double-blind, placebo-controlled, 3 phase study in 40 male or female subjects with seasonal allergic rhinitis. The subjects will be randomised to receive either fluticasone propionate aqueous nasal spray or matched placebo. The study consists of three phases with each phase consists of 2 treatment periods. A screening visit will be followed by Phase 1 (Vienna Chamber Challenge out of season), Phase 2 (Park Study, in season) and Phase 3 (Vienna Chamber Challenge in season). There will be a follow-up visit after Phase 1 and Phase 2 & 3 will be separated by a 10 day wash-out period. A follow-up visit will be completed 7-14 days after the last received dose. Intranasal fluticasone propionate will be administered daily for 8 days in the VCC and up to 14 days in the Park Study. Primary assessment will consist of major symptoms complex (MSC) during a 5-hour pollen allergen challenge in the Vienna Challenge Chamber (VCC) following final dosing on Day 8 and following final dosing between Day 8 and Day 14 in the Park Study. In addition, nasal flow measured by anterior rhinomanometry, wet tissue weight (as a surrogate of nasal secretion) and categorical scores for ocular symptoms, cough, itchy throat and itchy ears will be measured on day 8 (VCC) or on a day between 8-14 (Park). |
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| Detailed Description | A randomised, double blind, placebo controlled, two-way crossover, three phase, study, to investigate the trial models, Vienna Challenge Chamber, in and out of season, and Park Study in season and the clinical efficacy of repeat doses of fluticasone propionate in subjects with seasonal allergic rhinitis (SAR). |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Retrospective | ||||
| Condition ICMJE | Allergic Rhinitis | ||||
| Intervention ICMJE | Drug: Fluticasone Propionate | ||||
| 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 | 48 | ||||
| Completion Date | November 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Austria | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00400998 | ||||
| Responsible Party | Study Director, GSK | ||||
| Study ID Numbers ICMJE | HH3104994 | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | October 2008 | ||||
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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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