Omnaris Versus Levocetirizine Phase 4 Study
Information source: Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Rhinitis
Intervention: Ciclesonide (Drug); Levocetirizine (Drug); Ciclesonide & Levocetirizine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Handok Pharmaceuticals Co., Ltd. Official(s) and/or principal investigator(s): Moonhwa Park, Doctor, Study Director, Affiliation: Handok Pharmaceuticals Co., Ltd.
Summary
This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in
combination.
Clinical Details
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: rTOSSTNSS PANS RQLQ
Detailed description:
randomized, open-label, three arm, parallel group, multi-center study
Eligibility
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)
Locations and Contacts
handok pharmaceuticals co. LTD, Seoul 135-755, Korea, Republic of
Additional Information
Starting date: January 2011
Last updated: September 5, 2012
|