Efficacy and Safety of Mometasone Furoate Plus Azelastine HCl Combination Versus Mometasone Furoate Alone or Azelastine Alone in Patients With Perennial Allergic Rhinitis

A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Mometasone Furoate/Azelastine Hydrochloride Combination Group and Mometasone Furoate and Azelastine Hydrochloride Group 4 Weeks After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Perennial Allergic Rhinitis Patient.

The purpose of this study is to evaluate of efficacy and safety of mometasone furoate plus azelastine HCl in patients with perennial allergic rhinitis.

Inclusion Criteria:

• Patients over 12 years of age
• Medical history of perennial allergic rhinitis for at least two years
• Moderate ro severe nasal symptom (during placebo run-in period AM rTNSS or PM rTNSS≥8)
• Positive skin prick test result within the previous 12 months

Exclusion Criteria:

• patients with active asthma that required therapy with inhaled or oral corticosteroids or long-term β-agonist
• patients with severe rhinostenosis, severely deviated nasal septum or local infection on the nasal mucous membrane
• patients with herpes zoster, glaucoma or cataract
• patients with history of operation or damage on nasal cavity or ocular region
• patients with drug-induced rhinitis
• patients with history of respiratory infection which requires antibiotic therapy within the previous 14 days
• Patients with lung disease including COPD
• Patients with history of immunotherapy or ongoing immunotherapy
• patients administered with super potent or potent corticosteroid
• patients administered with intra-muscular or intra-articular steroid within the previous 3 months
• patients administered with subcutaneous omalizumab within the previous 5 months