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

Phase 3

Completed

• Conditions: Perennial Allergic Rhinitis
• Interventions: Drug: mometasone furoate plus azelastine HCl; Drug: azelastine HCl; Drug: mometasone furoate

• Registration Number: NCT01470053
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Status Verified: 2011-11
• Study First Submitted: 2011-11-08
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-11
• Primary Completion: 2011-12
• Study Completion: 2012-11
• Last Update Submitted: 2013-08-26
• Last Update Posted: 2013-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 347

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mometasone furoate + azelastin HCl	mometasone furoate plus azelastine HCl	opaque suspension, four times each naris per day
azelastine HCl	azelastine HCl	lucidus colorless liquid, two times each naris per day
mometasone furoate	mometasone furoate	opaque suspension, four times each naris per day

Primary Outcome Measures

Name	Time	Method
change from baseline in rTNSS(reflective Total Nasal Symptom Score)	4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of