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Omnaris Versus Levocetirizine Phase 4 Study

NCT ID: NCT01430260

Last Updated: 2012-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

349 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-07-31

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

Conditions

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Allergic Rhinitis

Keywords

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efficacy ciclesonide levocetirizine allergic rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ciclesonide nasal spray

ciclesonide nasal spray, alone

Group Type EXPERIMENTAL

Ciclesonide

Intervention Type DRUG

200 ㎍ once daily

Levocetirizine

Levocetirizine, alone

Group Type ACTIVE_COMPARATOR

Levocetirizine

Intervention Type DRUG

5mg once daily

Ciclesonide nasal spray & Levocetirizine

Ciclesonide nasal spray \& Levocetirizine in combination

Group Type ACTIVE_COMPARATOR

Ciclesonide & Levocetirizine

Intervention Type DRUG

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

Interventions

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Ciclesonide

200 ㎍ once daily

Intervention Type DRUG

Levocetirizine

5mg once daily

Intervention Type DRUG

Ciclesonide & Levocetirizine

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

Intervention Type DRUG

Other Intervention Names

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Omnaris XYZAL Omnaris nasal spray XYZAL

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role collaborator

Handok Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moonhwa Park, Doctor

Role: STUDY_DIRECTOR

Handok Inc.

Locations

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handok pharmaceuticals co. LTD

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HANDOK2010.07

Identifier Type: -

Identifier Source: org_study_id