Omnaris Versus Levocetirizine Phase 4 Study

Condition(s) targeted: Allergic Rhinitis

Intervention: Ciclesonide (Drug); Levocetirizine (Drug); Ciclesonide & Levocetirizine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Handok Pharmaceuticals Co., Ltd.

Official(s) and/or principal investigator(s):
Moonhwa Park, Doctor, Study Director, Affiliation: Handok Pharmaceuticals Co., Ltd.

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

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: rTNSS

Secondary outcome:

rTOSS

TNSS

PANS

RQLQ

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

handok pharmaceuticals co. LTD, Seoul 135-755, Korea, Republic of; Recruiting
Mina Hong, Bachelor, Phone: 82-2-527-5553, Ext: 553, Email: mina.hong@handok.com
Juheon Yoon, Doctor, Phone: 82-2-2228-2000, Ext: 8200, Email: jhyoon@yuhs.ac

Starting date: January 2011
Last updated: September 7, 2011