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This is an 8 day, randomised, double blind, 3-way crossover trial of repeat doses of intranasal GSK256066 and fluticasone propionate in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR). Approximately 60 subjects will be selected for enrolment with the intention of acquiring at least 48 evaluable subjects. Laboratory safety assessments, 12-lead electrocardiograph (ECG), vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores, nasal lavage, nasal scrape and allergen challenge assessments will also be performed at various time points throughout the study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
GSK256066, fluticasone propionate
GSK Investigational Site
Published on BioPortfolio: 2014-07-24T14:18:53-0400
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Randomized, Placebo Controlled, Crossover Study in an Environmental Challenge Chamber to Assess Safety & Efficacy of Three Oral Doses of BI 671800 Versus Fluticasone Propionate and Montelukast in Sensitive Seasonal Allergic Rhinitis Patients Out of Season
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This study is in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of repeat doses of intranasal GSK256066 using the Vienna Challenge Chamber. GSK25...
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