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

Primary Purpose

Perennial Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
mometasone furoate plus azelastine HCl
mometasone furoate
azelastine HCl
Sponsored by
Hanlim Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perennial Allergic Rhinitis focused on measuring mometasone furoate, azelastine HCl, perennial allergic rhinitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

mometasone furoate + azelastin HCl

mometasone furoate

azelastine HCl

Arm Description

opaque suspension, four times each naris per day

opaque suspension, four times each naris per day

lucidus colorless liquid, two times each naris per day

Outcomes

Primary Outcome Measures

change from baseline in rTNSS(reflective Total Nasal Symptom Score)

Secondary Outcome Measures

change from baseline in AM rTNSS(AM reflective Total Nasal Symptom Score)
change from baseline in PM rTNSS(PM reflective Total Nasal Symptom Score)
change from baseline in iTNSS(instantaneous Total Nasal Symptom Score)
change from baseline in AM iTNSS(AM instantaneous Total Nasal Symptom Score)
change from baseline in PM iTNSS(PM instantaneous Total Nasal Symptom Score)

Full Information

First Posted
November 8, 2011
Last Updated
August 26, 2013
Sponsor
Hanlim Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01470053
Brief Title
Efficacy and Safety of Mometasone Furoate Plus Azelastine HCl Combination Versus Mometasone Furoate Alone or Azelastine Alone in Patients With Perennial Allergic Rhinitis
Official Title
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
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanlim Pharm. Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis
Keywords
mometasone furoate, azelastine HCl, perennial allergic rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
347 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mometasone furoate + azelastin HCl
Arm Type
Experimental
Arm Description
opaque suspension, four times each naris per day
Arm Title
mometasone furoate
Arm Type
Active Comparator
Arm Description
opaque suspension, four times each naris per day
Arm Title
azelastine HCl
Arm Type
Active Comparator
Arm Description
lucidus colorless liquid, two times each naris per day
Intervention Type
Drug
Intervention Name(s)
mometasone furoate plus azelastine HCl
Other Intervention Name(s)
Nasaflex Nasal Spray
Intervention Type
Drug
Intervention Name(s)
mometasone furoate
Other Intervention Name(s)
NASONEX NASAL SPRAY
Intervention Type
Drug
Intervention Name(s)
azelastine HCl
Other Intervention Name(s)
AZEPTIN NASAL
Primary Outcome Measure Information:
Title
change from baseline in rTNSS(reflective Total Nasal Symptom Score)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
change from baseline in AM rTNSS(AM reflective Total Nasal Symptom Score)
Time Frame
4 weeks
Title
change from baseline in PM rTNSS(PM reflective Total Nasal Symptom Score)
Time Frame
4 weeks
Title
change from baseline in iTNSS(instantaneous Total Nasal Symptom Score)
Time Frame
4 weeks
Title
change from baseline in AM iTNSS(AM instantaneous Total Nasal Symptom Score)
Time Frame
4 weeks
Title
change from baseline in PM iTNSS(PM instantaneous Total Nasal Symptom Score)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Gi Min, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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