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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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.

NCT01470053•Hanlim Pharm. Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - No limit years

Sex

ALL

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
+1 more criteria

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Key Dates

Start Date

March 1, 2011

Primary Completion Date

December 1, 2011

Completion Date

November 1, 2012

Last Updated

August 27, 2013

Enrollment

347

ACTUAL participants

Conditions

Perennial Allergic Rhinitis

Interventions

mometasone furoate plus azelastine HCl

DRUG

mometasone furoate

DRUG

azelastine HCl

DRUG

A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

NCT01425632

Perennial Allergic Rhinitis

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TERMINATEDPHASE3

Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis

NCT04874714

Allergic RhinoconjunctivitisPerennial Allergic Rhinitis+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 27, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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