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