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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT01748344
First received: November 1, 2012
Last updated: April 14, 2014
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Cetirizine
Drug: High dose ONO-4053
Drug: Low dose ONO-4053
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • Total Nasal Symptom Score [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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:
  • Total Nasal Symptom Score [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.

  • Total Ocular Symptom Score [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Itching and ocular discharge monitored daily

  • Pharmacokinetics [ Time Frame: Days 1 and 8 ] [ Designated as safety issue: No ]
    AUE (0-2h, 2-6h and 0-6h)


Enrollment: 58
Study Start Date: November 2012
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental 1
High dose ONO-4053
Drug: High dose ONO-4053
Experimental
Other Name: Experimental 1
Active Comparator: Cetirizine
10mg Cetirizine
Drug: Cetirizine
10mg tablets
Other Name: Cetirizine
Experimental: Experimental 2
Low dose ONO-4053
Drug: Low dose ONO-4053
Experimental
Other Name: Experimental 2
Placebo Comparator: Placebo
Placebo
Drug: Placebo
None active

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748344

Locations
Austria
Vienna Clinical Site
Vienna, Austria
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Study Director Ono Pharmaceutical Co. Ltd
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT01748344     History of Changes
Other Study ID Numbers: ONO-4053POE003
Study First Received: November 1, 2012
Last Updated: April 14, 2014
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Cetirizine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014