The Effects of OC000459 on Nasal Mediators

This study has been completed.
Sponsor:
Collaborator:
Oxagen Ltd
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00290381
First received: February 10, 2006
Last updated: September 7, 2006
Last verified: September 2006
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Further study details as provided by Imperial College London:

Estimated Enrollment: 20
Study Start Date: February 2006
Estimated Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00290381     History of Changes
Other Study ID Numbers: OC000459/005/05
Study First Received: February 10, 2006
Last Updated: September 7, 2006
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Allergic rhinitis

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

ClinicalTrials.gov processed this record on September 29, 2014