Clinical Trial: A Study Of The Effects Of OC000459 In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Oxagen Ltd

Current Primary Outcome: Efficacy of OC00045 on response to allergen challenge as measured by change in Total Nasal Symptom Score [ Time Frame: 8 days ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • OC000459 safety as determined by adverse events, laboratory parameters, lung function and vital signs [ Time Frame: 8 days ]
    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 ]
    To assess plasma levels of OC000459 at the time of allergen challenge (trough plasma level).


Original Secondary Outcome: Same as current

Information By: Oxagen Ltd

Dates:
Date Received: July 27, 2011
Date Started: March 2007
Date Completion:
Last Updated: October 6, 2011
Last Verified: October 2011