The Effects of OC000459 on Nasal Mediators
This is the first proof of concept study for OC000459 and is undertaken to assess the effects of the compound on the development of inflammatory cytokines in a model (nasal allergen challenge model) that is validated and clinically safe and easy to conduct. OC000459 will be compared with placebo in the study.
The study will be a randomised, double blind, placebo controlled, crossover evaluation of the effect of OC000459 on cytokine secretion induced by nasal allergen challenge. Male subjects with a known history of allergic rhinitis and screening positive to allergen will be included. After dosing with OC000459 or placebo, nasal allergen challenge will be performed and measurements made in the nasal fluids. Nasal symptom scores will also be recorded. Safety parameters will be monitored throughout.
|Allergic Rhinitis||Drug: Study drug administration Procedure: Skin prick test Procedure: 12-lead ECG Procedure: Laboratory safety samples Procedure: Alcohol breath test Procedure: Smokerlyzer test Procedure: Urine drug test Procedure: Blood test for drug concentrations Procedure: Nasal allergen challenge Procedure: Nasal filter paper placement Procedure: Total nasal symptoms scores||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Diagnostic
|Official Title:||The Effects of OC000459 on Nasal Th2 Cytokine Release, Eosinophil Responses, and Nasal Symptoms After Nasal Allergen Challenge (NAC) With Timothy Grass Pollen in Subjects With Allergic Rhinitis Out of Season|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290381
|National Heart & Lung Institute Clinical Studies Unit|
|London, United Kingdom, SW3 6HP|
|Principal Investigator:||Trevor T Hansel, FRCPath||National Heart & Lung Institute|