The Effects of OC000459 on Nasal Mediators

Trevor Hansel

Status and phase: Completed; Phase 2; Phase 1

Conditions: Allergic Rhinitis

Treatments: Procedure: Oxagen OC000459

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00290381

OC000459/005/05

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.

Exclusion criteria

1. Medical conditions likely to affect the outcome of the study.

2 History of immunotherapy in the past 3 years or currently on an immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.

3. Any infirmity, disability, or geographic location which, in the opinion of the principal investigator, would limit compliance with the protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups

Placebo followed by Drug (OC000459)

Experimental group

Description:

Placebo and Drug are followed by Nasal Allergen Challenge

Treatment:

Procedure: Oxagen OC000459

Drug (OC000459) followed by Placebo

Experimental group

Description:

Drug and Placebo are followed by Nasal Allergen Challenge

Treatment:

Procedure: Oxagen OC000459