Omnaris Versus Levocetirizine Phase 4 Study

September 5, 2012 updated by: Handok Inc.

A Multi-center, Open, Randomized, Three-arm, Parallel-group, Phase IV Study to Compare the Efficacy of Ciclesonide Nasal Spray and Levocetirizine, Alone and in Combination for the Patient With Allergic Rhinitis

This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in combination.

Study Overview

Detailed Description

randomized, open-label, three arm, parallel group, multi-center study

Study Type

Interventional

Enrollment (Actual)

349

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Allergic rhinitis patients aged ≥ 18 years (with a history of AR of 1 years or longer)
  • Moderate to severe patient according to ARIA guideline
  • To have a demonstrated positive skin prick test or other serologic tests to at least 1 allergen.
  • Subjects who complete the subject diary(S) at least 70%.

Exclusion Criteria:

  • Nasal pathology, including nasal polyps, clinically relevant respiratory tract malformations, recent nasal biopsy (within 60 days), nasal trauma, nasal surgery, atrophic rhinitis, rhinitis medicamentosa (within 60 days), asthma requiring corticosteroid treatment
  • Hypersensitivity to corticosteroid and/or hydroxyzine
  • Hypersensitivity to galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
  • A history of respiratory tract infection or disorder within 2 weeks of the screening visit or had a respiratory tract infection during baseline
  • Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of β-agonists
  • Treated with systemic corticosteroids (within 8 weeks of study initiation) or topical corticosteroids (> 1% hydrocortisone, within 4 weeks of study initiation) or antibiotics (within 2 weeks of first visit)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ciclesonide nasal spray
ciclesonide nasal spray, alone
200 ㎍ once daily
Other Names:
  • Omnaris
Active Comparator: Levocetirizine
Levocetirizine, alone
5mg once daily
Other Names:
  • XYZAL
Active Comparator: Ciclesonide nasal spray & Levocetirizine
Ciclesonide nasal spray & Levocetirizine in combination
  • Omnaris (ciclesonide) 200 ㎍ once daily
  • Levocetirizine 5mg once daily
Other Names:
  • XYZAL
  • Omnaris nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rTNSS
Time Frame: 2 weeks
change from baseline in the average of AM and PM patient assessed reflective TNSS
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rTOSS
Time Frame: 2 weeks
Reflective total ocular symptom sores
2 weeks
TNSS
Time Frame: 2 weeks
Patient assessed individual TNSS
2 weeks
PANS
Time Frame: 2 weeks
Physician-assessed overall nasal signs and symptoms severity (PANS)
2 weeks
RQLQ
Time Frame: 2 weeks
Rhinoconjunctivitis quality of life questionnaire (RQLQ)
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Study Director: Moonhwa Park, Doctor, Handok Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

September 6, 2011

First Submitted That Met QC Criteria

September 7, 2011

First Posted (Estimate)

September 8, 2011

Study Record Updates

Last Update Posted (Estimate)

September 6, 2012

Last Update Submitted That Met QC Criteria

September 5, 2012

Last Verified

September 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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