- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01430260
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
Status
Completed
Conditions
Intervention / Treatment
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
-
-
-
Seoul, Korea, Republic of, 135-755
- Handok Pharmaceuticals CO. LTD
-
-
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:
|
Active Comparator: Levocetirizine
Levocetirizine, alone
|
5mg once daily
Other Names:
|
Active Comparator: Ciclesonide nasal spray & Levocetirizine
Ciclesonide nasal spray & Levocetirizine in combination
|
Other Names:
|
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
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Cetirizine
- Ciclesonide
- Levocetirizine
Other Study ID Numbers
- HANDOK2010.07
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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