Omnaris Versus Levocetirizine Phase 4 Study

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

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

Official Title
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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

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Ciclesonide
* Drug: Levocetirizine
* Drug: Ciclesonide & Levocetirizine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ciclesonide nasal spray<br>ciclesonide nasal spray, alone | Drug: Ciclesonide<br>* 200 ㎍ once daily<br>* Other names: Omnaris;|
| Active Comparator: Levocetirizine<br>Levocetirizine, alone | Drug: Levocetirizine<br>* 5mg once daily<br>* Other names: XYZAL;|
| Active Comparator: Ciclesonide nasal spray & Levocetirizine<br>Ciclesonide nasal spray & Levocetirizine in combination | Drug: Ciclesonide & Levocetirizine<br>* Omnaris (ciclesonide) 200 ㎍ once daily Levocetirizine 5mg once daily<br>* Other names: XYZAL;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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efficacy, ciclesonide, levocetirizine, allergic rhinitis