Clinical trial NCT01470053: Efficacy and Safety of Mometasone Furoate Plus Azelastine HCl Combination Versus Mometasone Furoate Alone or Azelastine Alone in Patients With Perennial Allergic Rhinitis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Keywords: mometasone furoate
azelastine HCl
perennial allergic rhinitis
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-11-11
Enrollment: 347
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: change from baseline in rTNSS(reflective Total Nasal Symptom Score)
timeFrame: 4 weeks
Secondary outcomes:
measure: change from baseline in AM rTNSS(AM reflective Total Nasal Symptom Score)
timeFrame: 4 weeks
measure: change from baseline in PM rTNSS(PM reflective Total Nasal Symptom Score)
timeFrame: 4 weeks
measure: change from baseline in iTNSS(instantaneous Total Nasal Symptom Score)
timeFrame: 4 weeks
measure: change from baseline in AM iTNSS(AM instantaneous Total Nasal Symptom Score)
timeFrame: 4 weeks
measure: change from baseline in PM iTNSS(PM instantaneous Total Nasal Symptom Score)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yang Gi Min, M.D.
role: PRINCIPAL_INVESTIGATOR
References: