OC000459 Dose Finding Study in Hay Fever Sufferers.

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate a range of dose levels for efficacy in the control of symptoms of allergic rhinitis

Detailed Description
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This will be a randomised, double blind, placebo controlled, parallel group evaluation of OC000459 given orally for eight days. Four dose levels will be studied and compared to placebo. They will be studied in treatment groups of 18 to 21 subjects. The placebo group will also consist of 18 to 21 subjects. There will be a screening period of up to six weeks. There will be a follow up one to three weeks after the last dose of study drug.

Official Title
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A Dose Finding 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.

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: OC000459
* Drug: OC000459
* Drug: OC000459
* Drug: OC000459
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years. Females of childbearing potential (i.e. having had a menstrual period within two years prior to the date of screening) must practise two forms of contraception and must have a negative pregnancy test (blood or urine) at screening. Acceptable contraception includes the use of TWO of the following: oral contraception (i.e. the Pill); intrauterine device (an IUD or 'Coil'); barrier contraception (i.e. condoms or diaphragm/cap); transdermal patch 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 as determined by the principal investigator or designee. Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (defined as FEV1 ≥ 90% predicted for height and age). Immunotherapy treatment course in the past 28 days Use of inhaled or local corticosteroids in the past 28 days.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose level 1 | Drug: OC000459<br>* Tablets twice daily for 8 days Dose level 1<br>|
| Experimental: 2<br>Dose level 2 | Drug: OC000459<br>* Tablets twice daily for 8 days Dose level 2<br>|
| Experimental: 3<br>Dose level 3 | Drug: OC000459<br>* Tablets twice daily for 8 days Dose level 3<br>|
| Experimental: 4<br>Dose level 4 | Drug: OC000459<br>* Tablets twice daily for 8 days Dose level 4<br>|
| Experimental: 5<br>Dose level 5 | Drug: Placebo<br>* Tablets twice daily for 8 days Dose level 5<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total nasal symptom score (TNSS) |  | After 8 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other symptom scores of allergic rhinitis |  | After 8 days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allergic rhinitis, human, clinical trial, efficacy, safety, challenge test