Status:
COMPLETED
A Study Of The Effects Of OC000459 In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis
Lead Sponsor:
Oxagen Ltd
Conditions:
Allergic Rhinitis
Eligibility:
MALE
18-50 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.
- Subjects must be free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and screening investigations.
- FEV1 within normal limits (≥90% of predicted).
- Atopy defined by a positive cutaneous response to mixed grass pollen within the last 12 months or at screening.
- Asymptomatic at screening
- Non smokers for at least the past 12 months
Exclusion
- Medical conditions likely to affect the outcome of the study.
- Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases.
- Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function
- Immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01448902
Start Date
March 1 2007
End Date
May 1 2007
Last Update
October 7 2011
Active Locations (1)
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1
Vienna Challenge Chamber
Vienna, Austria