Phase II Study Evaluating ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Brief Summary

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The purpose of this study is to investigate if ONO-4053 relieves symptoms of allergic rhinitis in seasonal allergic rhinitis subjects exposed to pollen under controlled conditions.

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Detailed Description

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The purpose of this study is to investigate if ONO-4053 will impact allergic rhinitis symptoms in subjects with seasonal allergic rhinitis when they are exposed to pollen administered at a fixed rate in an inhalation exposure chamber compared to the standard treatment Cetirizine 10mg under the same conditions.

Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental 1

High dose ONO-4053

Group Type EXPERIMENTAL

High dose ONO-4053

Intervention Type DRUG

Experimental

Cetirizine

10mg Cetirizine

Group Type ACTIVE_COMPARATOR

Cetirizine

Intervention Type DRUG

10mg tablets

Experimental 2

Low dose ONO-4053

Group Type EXPERIMENTAL

Low dose ONO-4053

Intervention Type DRUG

Experimental

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

None active

Interventions

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Cetirizine

10mg tablets

Intervention Type DRUG

High dose ONO-4053

Experimental

Intervention Type DRUG

Low dose ONO-4053

Experimental

Intervention Type DRUG

Placebo

None active

Intervention Type DRUG

Other Intervention Names

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Experimental 1 Experimental 2

Eligibility Criteria

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Inclusion Criteria

* The subject is aged between 18 and 65 years inclusive, and healthy with the exception of allergic rhinitis or mild asthma that does not require treatment and has provided written informed consent, which signifies an agreement to enter the study and comply with the restrictions and requirements listed in the informed consent form.
* The subject exhibits a moderate to severe response to grass pollen grains in the allergen challenge chamber at Screening.

Exclusion Criteria

* The subject on examination is found to have nasal structural abnormalities or nasal polyps; a history of frequent nose bleeds, nasal biopsy, nasal trauma or nasal surgery.
* Pregnant or breast-feeding females.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No