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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000017-11 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OC000459 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OC000459 | Drug | OC000459 200mg bid for 8 days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 days |
| OC000459 plasma concentration (Cmin) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Friedrich Horak, Prof Dr | Vienna Challenge Chamber | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna Challenge Chamber | Vienna | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23025511 | Derived | 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. |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| C571151 | (5-fluoro-2-methyl-3-quinolin-2-ylmethylindo-1-yl)acetic acid |
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| Drug |
Placebo bid for 8 days |
|
To assess plasma levels of OC000459 at the time of allergen challenge (trough plasma level). |
| 8 days |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |