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

August 26, 2013 updated by: Hanlim Pharm. Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

347

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mometasone furoate + azelastin HCl
opaque suspension, four times each naris per day
Drug: mometasone furoate plus azelastine HCl
Other Names:
  • Nasaflex Nasal Spray
Active Comparator: mometasone furoate
opaque suspension, four times each naris per day
Drug: mometasone furoate
Other Names:
  • NASONEX NASAL SPRAY
Active Comparator: azelastine HCl
lucidus colorless liquid, two times each naris per day
Drug: azelastine HCl
Other Names:
  • AZEPTIN NASAL

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanlim Pharm. Co., Ltd.

Investigators

  • Principal Investigator: Yang Gi Min, M.D., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

November 8, 2011

First Submitted That Met QC Criteria

November 10, 2011

First Posted (Estimate)

November 11, 2011

Study Record Updates

Last Update Posted (Estimate)

August 27, 2013

Last Update Submitted That Met QC Criteria

August 26, 2013

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL_NSFX_301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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