Omnaris Versus Levocetirizine Phase 4 Study

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01430260

Enrollment

349

Registered

2011-09-08

Start date

2011-01-31

Completion date

2012-07-31

Last updated

2012-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

efficacy, ciclesonide, levocetirizine, allergic rhinitis

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

Interventions

DRUGCiclesonide

200 ㎍ once daily

DRUGLevocetirizine

5mg once daily

DRUGCiclesonide & Levocetirizine

* Omnaris (ciclesonide) 200 ㎍ once daily * Levocetirizine 5mg once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026