Status:
COMPLETED
Efficacy and Safety of Mometasone Furoate Plus Azelastine HCl Combination Versus Mometasone Furoate Alone or Azelastine Alone in Patients With Perennial Allergic Rhinitis
Lead Sponsor:
Hanlim Pharm. Co., Ltd.
Conditions:
Perennial Allergic Rhinitis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT01470053
Start Date
March 1 2011
End Date
November 1 2012
Last Update
August 27 2013
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744