Omnaris Versus Levocetirizine Phase 4 Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01430260
Recruitment Status : Completed
First Posted : September 8, 2011
Last Update Posted : September 6, 2012
Information provided by (Responsible Party):
Handok Pharmaceuticals Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: Ciclesonide Drug: Levocetirizine Drug: Ciclesonide & Levocetirizine Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 349 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2011
Primary Completion Date : July 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ciclesonide nasal spray
ciclesonide nasal spray, alone
Drug: Ciclesonide
200 ㎍ once daily
Other Name: Omnaris
Active Comparator: Levocetirizine
Levocetirizine, alone
Drug: Levocetirizine
5mg once daily
Other Name: XYZAL
Active Comparator: Ciclesonide nasal spray & Levocetirizine
Ciclesonide nasal spray & Levocetirizine in combination
Drug: Ciclesonide & Levocetirizine
  • Omnaris (ciclesonide) 200 ㎍ once daily
  • Levocetirizine 5mg once daily
Other Names:
  • Omnaris nasal spray

Primary Outcome Measures :
  1. rTNSS [ Time Frame: 2 weeks ]
    change from baseline in the average of AM and PM patient assessed reflective TNSS

Secondary Outcome Measures :
  1. rTOSS [ Time Frame: 2 weeks ]
    Reflective total ocular symptom sores

  2. TNSS [ Time Frame: 2 weeks ]
    Patient assessed individual TNSS

  3. PANS [ Time Frame: 2 weeks ]
    Physician-assessed overall nasal signs and symptoms severity (PANS)

  4. RQLQ [ Time Frame: 2 weeks ]
    Rhinoconjunctivitis quality of life questionnaire (RQLQ)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01430260

Korea, Republic of
handok pharmaceuticals co. LTD
Seoul, Korea, Republic of, 135-755
Sponsors and Collaborators
Handok Pharmaceuticals Co., Ltd.
Study Director: Moonhwa Park, Doctor Handok Pharmaceuticals Co., Ltd.

Responsible Party: Handok Pharmaceuticals Co., Ltd. Identifier: NCT01430260     History of Changes
Other Study ID Numbers: HANDOK2010.07
First Posted: September 8, 2011    Key Record Dates
Last Update Posted: September 6, 2012
Last Verified: September 2012

Keywords provided by Handok Pharmaceuticals Co., Ltd.:
allergic rhinitis

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action