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

Oxagen

Status and phase

Completed

Phase 2

Conditions

Allergic Rhinitis

Treatments

Drug: OC000459

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01448902

2007-000017-11 (EudraCT Number)

OC000459/007/06

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.