A Study Of The Effects Of OC000459 In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oxagen Ltd
ClinicalTrials.gov Identifier:
NCT01448902
First received: July 27, 2011
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

The study will assess the efficacy of OC000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours. This is a randomised, double blind, placebo controlled, two way crossover evaluation. There will be a screening period of up to three weeks and a washout period of at least one week between the two treatment periods. There will be a follow up one to three weeks after the last dose of study drug.


Condition Intervention Phase
Allergic Rhinitis
Drug: OC000459
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study Of The Effects Of OC000459 On Responses To Allergen Challenge In The Vienna Chamber In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis

Further study details as provided by Oxagen Ltd:

Primary Outcome Measures:
  • Efficacy of OC00045 on response to allergen challenge as measured by change in Total Nasal Symptom Score [ Time Frame: 8 days ] [ Designated as safety issue: No ]
    To assess the efficacy of OC000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours as shown by the effect on Total Nasal Symptom Score


Secondary Outcome Measures:
  • OC000459 safety as determined by adverse events, laboratory parameters, lung function and vital signs [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
    To assess the safety of this treatment schedule in male subjects with allergic rhinitis as assessed via adverse events, clinical chemistry and haematology, FEV1 and vital signs.

  • OC000459 plasma concentration (Cmin) [ Time Frame: 8 days ] [ Designated as safety issue: No ]
    To assess plasma levels of OC000459 at the time of allergen challenge (trough plasma level).


Enrollment: 36
Study Start Date: March 2007
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OC000459 Drug: OC000459
OC000459 200mg bid for 8 days
Placebo Comparator: Placebo Drug: Placebo
Placebo bid for 8 days

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.
  • Subjects must be free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and screening investigations.
  • FEV1 within normal limits (≥90% of predicted).
  • Atopy defined by a positive cutaneous response to mixed grass pollen within the last 12 months or at screening.
  • Asymptomatic at screening
  • Non smokers for at least the past 12 months

Exclusion Criteria:

  • Medical conditions likely to affect the outcome of the study.
  • Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases.
  • Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function
  • Immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.
  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: NCT01448902

Locations
Austria
Vienna Challenge Chamber
Vienna, Austria
Sponsors and Collaborators
Oxagen Ltd
Investigators
Principal Investigator: Friedrich Horak, Prof Dr Vienna Challenge Chamber
  More Information

No publications provided by Oxagen Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oxagen Ltd
ClinicalTrials.gov Identifier: NCT01448902     History of Changes
Other Study ID Numbers: OC000459/007/06, 2007-000017-11
Study First Received: July 27, 2011
Last Updated: October 6, 2011
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Oxagen Ltd:
Allergic rhinitis
CRTH2

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014