Status:
COMPLETED
Omnaris Versus Levocetirizine Phase 4 Study
Lead Sponsor:
Handok Inc.
Collaborating Sponsors:
Takeda
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in combination.
Detailed Description
randomized, open-label, three arm, parallel group, multi-center study
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
349 Patients enrolled
Trial Details
Trial ID
NCT01430260
Start Date
January 1 2011
End Date
July 1 2012
Last Update
September 6 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
handok pharmaceuticals co. LTD
Seoul, Seoul, South Korea, 135-755