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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanlim Pharm. Co., Ltd.
• Treatments: Azelastine; Mometasone Furoate

Criteria

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