The Effects of OC000459 on Nasal Mediators

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.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Heart & Lung Institute Clinical Studies Unit

London, SW3 6HP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

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

Treatment and study plan

Oxagen OC000459

Procedure

Primary outcomes

The Effect of OC000459 on Nasal Filter Paper Levels of IL-4, IL-5, IL-13

Time frame: 1 to 9 hours after nasal allergen challenge

Sponsors and collaborators

Lead sponsor

Trevor Hansel

Other

Collaborators

Oxagen Ltd

Registry information

Official study title

The Effects of OC000459 on Nasal Th2 Cytokine Release, Eosinophil Responses, and Nasal Symptoms After Nasal Allergen Challenge (NAC) With Timothy Grass Pollen in Subjects With Allergic Rhinitis Out of Season

Important dates

Primary completion: 2005
First posted: Feb 13, 2006
Registry last updated: Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed