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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

A Randomised, Placebo Controlled, Four Period Crossover Study to Evaluate the Efficacy, Safety of Oral Repeat Doses of ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis in the Vienna Challenge Chamber.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748344
• Other study ID #: ONO-4053POE003
• Status: Completed
• Phase: Phase 2
• First received: November 1, 2012
• Last updated: April 14, 2014
• Start date: November 2012

Study information

• Verified date: September 2012
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 58
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Cetirizine
10mg tablets
• High dose ONO-4053
Experimental
• Low dose ONO-4053
Experimental
• Placebo
None active

Locations

Country	Name	City	State
Austria	Vienna Clinical Site	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Nasal Symptom Score	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.	4 months	No
Secondary	Total Nasal Symptom Score	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.	4 months	No
Secondary	Total Ocular Symptom Score	Itching and ocular discharge monitored daily	4 months	No
Secondary	Pharmacokinetics	AUE (0-2h, 2-6h and 0-6h)	Days 1 and 8	No