The Effects of OC000459 on Nasal Mediators

Phase 1

Completed

• Conditions: Allergic Rhinitis
• Interventions: Procedure: Oxagen OC000459

• Registration Number: NCT00290381
• Lead Sponsor: Trevor Hansel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Primary Completion: 2005-02-01
• Study First Submitted: 2006-02-10
• Study First Submitted QC: 2006-02-10
• Study First Posted: 2006-02-13
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo followed by Drug (OC000459)	Oxagen OC000459	Placebo and Drug are followed by Nasal Allergen Challenge
Drug (OC000459) followed by Placebo	Oxagen OC000459	Drug and Placebo are followed by Nasal Allergen Challenge

Primary Outcome Measures

Name	Time	Method
The Effect of OC000459 on Nasal Filter Paper Levels of IL-4, IL-5, IL-13	1 to 9 hours after nasal allergen challenge

Trial Locations

Locations (1)

National Heart & Lung Institute Clinical Studies Unit; 🇬🇧 London, United Kingdom