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

Perennial Allergic Rhinitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470053
• Other study ID #: HL_NSFX_301
• Status: Completed
• Phase: Phase 3
• First received: November 8, 2011
• Last updated: August 26, 2013
• Start date: March 2011
• Est. completion date: November 2012

Study information

• Verified date: November 2011
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: November 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 ß-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

Study Design

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

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• mometasone furoate plus azelastine HCl

• mometasone furoate

• azelastine HCl

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in rTNSS(reflective Total Nasal Symptom Score)		4 weeks	No
Secondary	change from baseline in AM rTNSS(AM reflective Total Nasal Symptom Score)		4 weeks	No
Secondary	change from baseline in PM rTNSS(PM reflective Total Nasal Symptom Score)		4 weeks	No
Secondary	change from baseline in iTNSS(instantaneous Total Nasal Symptom Score)		4 weeks	No
Secondary	change from baseline in AM iTNSS(AM instantaneous Total Nasal Symptom Score)		4 weeks	No
Secondary	change from baseline in PM iTNSS(PM instantaneous Total Nasal Symptom Score)		4 weeks	No