A Study Of The Effects Of OC000459 In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis
The study will assess the efficacy of OC000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours. This is a randomised, double blind, placebo controlled, two way crossover evaluation. There will be a screening period of up to three weeks and a washout period of at least one week between the two treatment periods. There will be a follow up one to three weeks after the last dose of study drug.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Study Of The Effects Of OC000459 On Responses To Allergen Challenge In The Vienna Chamber In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis|
- Efficacy of OC00045 on response to allergen challenge as measured by change in Total Nasal Symptom Score [ Time Frame: 8 days ] [ Designated as safety issue: No ]To assess the efficacy of OC000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours as shown by the effect on Total Nasal Symptom Score
- OC000459 safety as determined by adverse events, laboratory parameters, lung function and vital signs [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]To assess the safety of this treatment schedule in male subjects with allergic rhinitis as assessed via adverse events, clinical chemistry and haematology, FEV1 and vital signs.
- OC000459 plasma concentration (Cmin) [ Time Frame: 8 days ] [ Designated as safety issue: No ]To assess plasma levels of OC000459 at the time of allergen challenge (trough plasma level).
|Study Start Date:||March 2007|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
OC000459 200mg bid for 8 days
|Placebo Comparator: Placebo||
Placebo bid for 8 days
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448902
|Vienna Challenge Chamber|
|Principal Investigator:||Friedrich Horak, Prof Dr||Vienna Challenge Chamber|