Omnaris Versus Levocetirizine Phase 4 Study

Phase 4

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: Ciclesonide & Levocetirizine; Drug: Ciclesonide; Drug: Levocetirizine

• Registration Number: NCT01430260
• Lead Sponsor: Handok Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-09-06
• Study First Submitted QC: 2011-09-07
• Study First Posted: 2011-09-08
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-05
• Last Update Posted: 2012-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 349

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ciclesonide nasal spray & Levocetirizine	Ciclesonide & Levocetirizine	Ciclesonide nasal spray \& Levocetirizine in combination
ciclesonide nasal spray	Ciclesonide	ciclesonide nasal spray, alone
Levocetirizine	Levocetirizine	Levocetirizine, alone

Primary Outcome Measures

Name	Time	Method
rTNSS	2 weeks	change from baseline in the average of AM and PM patient assessed reflective TNSS

Secondary Outcome Measures

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

Trial Locations

Locations (1)

handok pharmaceuticals co. LTD; 🇰🇷 Seoul, Korea, Republic of