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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01470053

Enrollment

347

Registered

2011-11-11

Start date

2011-03-31

Completion date

2012-11-30

Last updated

2013-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perennial Allergic Rhinitis

Keywords

mometasone furoate, azelastine HCl, perennial allergic rhinitis

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.

Interventions

DRUGmometasone furoate plus azelastine HCl

DRUGmometasone furoate

DRUGazelastine HCl

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026