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The Effects of OC000459 on Nasal Mediators

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ClinicalTrials.gov Identifier: NCT00290381
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : May 28, 2015
Sponsor:
Collaborator:
Oxagen Ltd
Information provided by:
Imperial College London

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.


Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: Study drug administration Procedure: Skin prick test Procedure: 12-lead ECG Procedure: Laboratory safety samples Procedure: Alcohol breath test Procedure: Smokerlyzer test Procedure: Urine drug test Procedure: Blood test for drug concentrations Procedure: Nasal allergen challenge Procedure: Nasal filter paper placement Procedure: Total nasal symptoms scores Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Diagnostic
Official 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
Study Start Date : February 2006
Study Completion Date : June 2006




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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290381


Locations
United Kingdom
National Heart & Lung Institute Clinical Studies Unit
London, United Kingdom, SW3 6HP
Sponsors and Collaborators
Imperial College London
Oxagen Ltd
Investigators
Principal Investigator: Trevor T Hansel, FRCPath National Heart & Lung Institute

ClinicalTrials.gov Identifier: NCT00290381     History of Changes
Other Study ID Numbers: OC000459/005/05
First Posted: February 13, 2006    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: September 2006

Keywords provided by Imperial College London:
Allergic rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases