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

Overview

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

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 2011

Interventions

  • Drug: mometasone furoate plus azelastine HCl
  • Drug: mometasone furoate
  • Drug: azelastine HCl

Arms, Groups and Cohorts

  • Experimental: mometasone furoate + azelastin HCl
    • opaque suspension, four times each naris per day
  • Active Comparator: mometasone furoate
    • opaque suspension, four times each naris per day
  • Active Comparator: azelastine HCl
    • lucidus colorless liquid, two times each naris per day

Clinical Trial Outcome Measures

Primary Measures

  • change from baseline in rTNSS(reflective Total Nasal Symptom Score)
    • Time Frame: 4 weeks

Secondary Measures

  • change from baseline in AM rTNSS(AM reflective Total Nasal Symptom Score)
    • Time Frame: 4 weeks
  • change from baseline in PM rTNSS(PM reflective Total Nasal Symptom Score)
    • Time Frame: 4 weeks
  • change from baseline in iTNSS(instantaneous Total Nasal Symptom Score)
    • Time Frame: 4 weeks
  • change from baseline in AM iTNSS(AM instantaneous Total Nasal Symptom Score)
    • Time Frame: 4 weeks
  • change from baseline in PM iTNSS(PM instantaneous Total Nasal Symptom Score)
    • Time Frame: 4 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hanlim Pharm. Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yang Gi Min, M.D., Principal Investigator, Seoul National University Hospital

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