Omnaris Versus Levocetirizine Phase 4 Study
Information source: Handok Pharmaceuticals Co., Ltd.
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Rhinitis
Intervention: Ciclesonide (Drug); Levocetirizine (Drug); Ciclesonide & Levocetirizine (Drug)
Phase: Phase 4
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
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
randomized, open-label, three arm, parallel group, multi-center study
Minimum age: 18 Years.
Maximum age: N/A.
- Allergic rhinitis patients aged ≥ 18 years (with a history of AR of 1 years or
- Moderate to severe patient according to ARIA guideline
- To have a demonstrated positive skin prick test or other serologic tests to at least
- Subjects who complete the subject diary(S) at least 70%.
- 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
- Hypersensitivity to corticosteroid and/or hydroxyzine
- Hypersensitivity to galactose intolerance, lapp lactase deficiency, glucose-galactose
- 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)
Locations and Contacts
handok pharmaceuticals co. LTD, Seoul 135-755, Korea, Republic of; Recruiting
Mina Hong, Bachelor, Phone: 82-2-527-5553, Ext: 553, Email: email@example.com
Juheon Yoon, Doctor, Phone: 82-2-2228-2000, Ext: 8200, Email: firstname.lastname@example.org
Starting date: January 2011
Last updated: September 7, 2011