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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

NCT ID: NCT01470053

Last Updated: 2013-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-11-30

Brief Summary

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

Detailed Description

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Conditions

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Perennial Allergic Rhinitis

Keywords

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mometasone furoate azelastine HCl perennial allergic rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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mometasone furoate + azelastin HCl

opaque suspension, four times each naris per day

Group Type EXPERIMENTAL

mometasone furoate plus azelastine HCl

Intervention Type DRUG

mometasone furoate

opaque suspension, four times each naris per day

Group Type ACTIVE_COMPARATOR

mometasone furoate

Intervention Type DRUG

azelastine HCl

lucidus colorless liquid, two times each naris per day

Group Type ACTIVE_COMPARATOR

azelastine HCl

Intervention Type DRUG

Interventions

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mometasone furoate plus azelastine HCl

Intervention Type DRUG

mometasone furoate

Intervention Type DRUG

azelastine HCl

Intervention Type DRUG

Other Intervention Names

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Nasaflex Nasal Spray NASONEX NASAL SPRAY AZEPTIN NASAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanlim Pharm. Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yang Gi Min, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HL_NSFX_301

Identifier Type: -

Identifier Source: org_study_id