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

Phase 2

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: High dose ONO-4053; Drug: Low dose ONO-4053; Drug: Placebo; Drug: Cetirizine

• Registration Number: NCT01748344
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-11
• Study First Submitted: 2012-11-01
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-12
• Primary Completion: 2014-02
• Last Update Submitted: 2014-04-14
• Last Update Posted: 2014-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental 1	High dose ONO-4053	High dose ONO-4053
Experimental 2	Low dose ONO-4053	Low dose ONO-4053
Placebo	Placebo	Placebo
Cetirizine	Cetirizine	10mg Cetirizine

Primary Outcome Measures

Name	Time	Method
Total Nasal Symptom Score	4 months	To investigate the effect of repeat oral doses of ONO-4053 versus placebo on nasal symptoms elicited by allergen chamber challenge in subjects with seasonal allergic rhinitis.

Secondary Outcome Measures

Name	Time	Method
Total Ocular Symptom Score	4 months	Itching and ocular discharge monitored daily
Total Nasal Symptom Score	4 months	To investigate the effect of repeat oral doses of ONO-4053 versus Cetirizine on nasal symptoms (Total Nasal Symptom Score) elicited by allergen chamber challenge in subjects with allergic rhinitis.
Pharmacokinetics	Days 1 and 8	AUE (0-2h, 2-6h and 0-6h)

Trial Locations

Locations (1)

Vienna Clinical Site; 🇦🇹 Vienna, Austria