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

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

Official Title
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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.

Conditions
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Perennial Allergic Rhinitis

Intervention / Treatment
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* Drug: mometasone furoate plus azelastine HCl
* Drug: mometasone furoate
* Drug: azelastine HCl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mometasone furoate + azelastin HCl<br>opaque suspension, four times each naris per day | Drug: mometasone furoate plus azelastine HCl<br> <br> * Other names: Nasaflex Nasal Spray;|
| Active Comparator: mometasone furoate<br>opaque suspension, four times each naris per day | Drug: mometasone furoate<br> <br> * Other names: NASONEX NASAL SPRAY;|
| Active Comparator: azelastine HCl<br>lucidus colorless liquid, two times each naris per day | Drug: azelastine HCl<br> <br> * Other names: AZEPTIN NASAL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in rTNSS(reflective Total Nasal Symptom Score) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in AM rTNSS(AM reflective Total Nasal Symptom Score) |  | 4 weeks | 
| change from baseline in PM rTNSS(PM reflective Total Nasal Symptom Score) |  | 4 weeks | 
| change from baseline in iTNSS(instantaneous Total Nasal Symptom Score) |  | 4 weeks | 
| change from baseline in AM iTNSS(AM instantaneous Total Nasal Symptom Score) |  | 4 weeks | 
| change from baseline in PM iTNSS(PM instantaneous Total Nasal Symptom Score) |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mometasone furoate, azelastine HCl, perennial allergic rhinitis