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

Ono Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Cetirizine; Drug: Placebo; Drug: Low dose ONO-4053; Drug: High dose ONO-4053

Study type: Interventional

Funder types: Industry

Identifiers

NCT01748344

ONO-4053POE003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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58 participants in 4 patient groups, including a placebo group

Experimental 1

Experimental group

Description:

High dose ONO-4053

Treatment:

Drug: High dose ONO-4053

Cetirizine

Active Comparator group

Description:

10mg Cetirizine

Treatment:

Drug: Cetirizine

Experimental 2

Experimental group

Description:

Low dose ONO-4053

Treatment:

Drug: Low dose ONO-4053

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo