Back to resultsA Study Of The Effects Of OC000459 In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
OC000459
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis focused on measuring Allergic rhinitis, CRTH2
Eligibility 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.
Sites / Locations
- Vienna Challenge Chamber
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
OC000459
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Efficacy of OC00045 on response to allergen challenge as measured by change in Total Nasal Symptom Score
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
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)
To assess plasma levels of OC000459 at the time of allergen challenge (trough plasma level).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01448902
Brief Title
A Study Of The Effects Of OC000459 In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxagen Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Allergic rhinitis, CRTH2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OC000459
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
OC000459
Intervention Description
OC000459 200mg bid for 8 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo bid for 8 days
Primary Outcome Measure Information:
Title
Efficacy of OC00045 on response to allergen challenge as measured by change in Total Nasal Symptom Score
Description
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
Time Frame
8 days
Secondary Outcome Measure Information:
Title
OC000459 safety as determined by adverse events, laboratory parameters, lung function and vital signs
Description
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.
Time Frame
8 days
Title
OC000459 plasma concentration (Cmin)
Description
To assess plasma levels of OC000459 at the time of allergen challenge (trough plasma level).
Time Frame
8 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friedrich Horak, Prof Dr
Organizational Affiliation
Vienna Challenge Chamber
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Challenge Chamber
City
Vienna
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
23025511
Citation
Horak F, Zieglmayer P, Zieglmayer R, Lemell P, Collins LP, Hunter MG, Steiner J, Lewis T, Payton MA, Perkins CM, Pettipher R. The CRTH2 antagonist OC000459 reduces nasal and ocular symptoms in allergic subjects exposed to grass pollen, a randomised, placebo-controlled, double-blind trial. Allergy. 2012 Dec;67(12):1572-9. doi: 10.1111/all.12042. Epub 2012 Oct 1.
Results Reference
derived
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A Study Of The Effects Of OC000459 In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis
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