MedPath

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
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.

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
GroupInterventionDescription
Experimental 1High dose ONO-4053High dose ONO-4053
Experimental 2Low dose ONO-4053Low dose ONO-4053
PlaceboPlaceboPlacebo
CetirizineCetirizine10mg Cetirizine
Primary Outcome Measures
NameTimeMethod
Total Nasal Symptom Score4 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
NameTimeMethod
Total Ocular Symptom Score4 months

Itching and ocular discharge monitored daily

Total Nasal Symptom Score4 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.

PharmacokineticsDays 1 and 8

AUE (0-2h, 2-6h and 0-6h)

Trial Locations

Locations (1)

Vienna Clinical Site

🇦🇹

Vienna, Austria

© Copyright 2025. All Rights Reserved by MedPath