Omnaris Versus Levocetirizine Phase 4 Study

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Handok Inc.; Handok Pharmaceuticals Co., Ltd.
• Collaborator: Takeda
• Treatments: Cetirizine; Ciclesonide; Levocetirizine

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)