The Effects of OC000459 on Nasal Mediators

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Procedure: Oxagen OC000459

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6HP
    • National Heart & Lung Institute Clinical Studies Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo followed by Drug (OC000459); Placebo and Drug are followed by Nasal Allergen Challenge	Procedure: Oxagen OC000459
Experimental: Drug (OC000459) followed by Placebo; Drug and Placebo are followed by Nasal Allergen Challenge	Procedure: Oxagen OC000459

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Trevor Hansel
• Collaborators: Oxagen Ltd
• Investigators: Principal Investigator: Trevor T Hansel, FRCPath, National Heart & Lung Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): February 1, 2005
• Study Completion: June 1, 2006

Study Registration Dates

• First Submitted: February 10, 2006
• First Submitted That Met QC Criteria: February 10, 2006
• First Posted (Estimated): February 13, 2006

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Allergic rhinitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: OC000459/005/05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No