The Effects of OC000459 on Nasal Mediators

NCT00290381 | Completed Phase 1

• 1 other identifier: OC000459/005/05
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitis

Outcome Measures

Primary Outcomes (1)

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

  1 to 9 hours after nasal allergen challenge

Study Arms (2)

Placebo followed by Drug (OC000459)

EXPERIMENTAL

Placebo and Drug are followed by Nasal Allergen Challenge

Procedure: Oxagen OC000459

Drug (OC000459) followed by Placebo

EXPERIMENTAL

Drug and Placebo are followed by Nasal Allergen Challenge

Procedure: Oxagen OC000459

Interventions

Oxagen OC000459 PROCEDURE

Drug (OC000459) followed by Placebo; Placebo followed by Drug (OC000459)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \. Medical conditions likely to affect the outcome of the study.
• 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.

Sponsors & Collaborators

• Trevor Hansel: lead
• Oxagen Ltd: collaborator

Study Sites (1)

National Heart & Lung Institute Clinical Studies Unit

London, SW3 6HP, United Kingdom

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

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

Study Officials

• Trevor T Hansel, FRCPath

  National Heart & Lung Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Imperial College

Model Details: Nasal Allergen Challenge Study

Study Record Dates

• First Submitted: February 10, 2006
• First Posted: February 13, 2006
• Primary Completion: February 1, 2005
• Last Updated: October 30, 2023

Record last verified: 2023-10

Locations

GB (1)