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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01470053
First received: November 8, 2011
Last updated: August 26, 2013
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: mometasone furoate plus azelastine HCl
Drug: mometasone furoate
Drug: azelastine HCl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Hanlim Pharm. Co., Ltd.:

Primary Outcome Measures:
  • change from baseline in rTNSS(reflective Total Nasal Symptom Score) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change from baseline in AM rTNSS(AM reflective Total Nasal Symptom Score) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • change from baseline in PM rTNSS(PM reflective Total Nasal Symptom Score) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • change from baseline in iTNSS(instantaneous Total Nasal Symptom Score) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • change from baseline in AM iTNSS(AM instantaneous Total Nasal Symptom Score) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • change from baseline in PM iTNSS(PM instantaneous Total Nasal Symptom Score) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 347
Study Start Date: March 2011
Study Completion Date: November 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mometasone furoate + azelastin HCl
opaque suspension, four times each naris per day
Drug: mometasone furoate plus azelastine HCl
Other Name: Nasaflex Nasal Spray
Active Comparator: mometasone furoate
opaque suspension, four times each naris per day
Drug: mometasone furoate
Other Name: NASONEX NASAL SPRAY
Active Comparator: azelastine HCl
lucidus colorless liquid, two times each naris per day
Drug: azelastine HCl
Other Name: AZEPTIN NASAL

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470053

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
Investigators
Principal Investigator: Yang Gi Min, M.D. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01470053     History of Changes
Other Study ID Numbers: HL_NSFX_301
Study First Received: November 8, 2011
Last Updated: August 26, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanlim Pharm. Co., Ltd.:
mometasone furoate
azelastine HCl
perennial allergic rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Azelastine
Mometasone furoate
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Lipoxygenase Inhibitors
Enzyme Inhibitors
Anti-Allergic Agents
Therapeutic Uses
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014