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Omnaris Versus Levocetirizine Phase 4 Study

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01430260
First received: September 6, 2011
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Allergic Rhinitis
Drug: Ciclesonide
Drug: Levocetirizine
Drug: Ciclesonide & Levocetirizine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Handok Pharmaceuticals Co., Ltd.:

Primary Outcome Measures:
  • rTNSS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    change from baseline in the average of AM and PM patient assessed reflective TNSS


Secondary Outcome Measures:
  • rTOSS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Reflective total ocular symptom sores

  • TNSS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Patient assessed individual TNSS

  • PANS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Physician-assessed overall nasal signs and symptoms severity (PANS)

  • RQLQ [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Rhinoconjunctivitis quality of life questionnaire (RQLQ)


Enrollment: 349
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • XYZAL

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430260

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

No publications provided

Responsible Party: Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT01430260     History of Changes
Other Study ID Numbers: HANDOK2010.07
Study First Received: September 6, 2011
Last Updated: September 5, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

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

ClinicalTrials.gov processed this record on November 27, 2014