Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap.

Study Overview
=================
Brief Summary
-----------------
Investigator examines the past prescription patterns and the reasons for the change of prescription to Monterizine capsules for Perennial Allergic Rhinitis patients with Asthma who will be taking Monterizine capsules to treat allergic rhinitis. After being given Monterizine capsules, Investigator evaluates the therapeutic effectiveness and safety for 3 months (or 6 months).

Detailed Description
-----------------
A Multi-center, Prospective, Observational Study

Official Title
-----------------
A Multi-center, Prospective, Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap in Patients With Asthma and Perennial Allergic Rhinitis.

Conditions
-----------------
Asthma, Perennial Allergic Rhinitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged ≥ 15 years Perennial allergic rhinitis patients with asthma who will be prescribed Monterizine capsules to treat allergic rhinitis Patients who provided a signed written informed consent form Exclusion Criteria: Highly sensitive patients to ingredients of Monterizine capsules, hydroxyzine or piperazine derivatives Patients with renal failure(CLCR,10ml/min) and hemodialysis patients A female who is pregnant, may be pregnant, or is lactating Patients with genetic problems like Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the average of TNSS at the point of Period 1 (recommended 3 Month(-1 Month)) as compared to baseline | The change in the average of TNSS at the point of Period 1 (recommended 3 Month(-1 Month)) as compared to baseline. *TNSS: Total symptom scores for nasal congestion, sneezing, runny nose and nasal itching during the daytime in the past week | 3 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the average of TNSS at the point of Period 2(recommended 6Month(±1Month)) as compared to baseline | The change in the average of TNSS at the point of Period 2(recommended 6Month(±1Month)) as compared to baseline | 6Month | 
| The change in the therapeutic satisfaction at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline | The change in the therapeutic satisfaction at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(1±Month)) as compared to baseline. *Therapeutic satisfaction : overall satisfaction with the treatment of allergic rhinitis for the past month. A possible scale is then: Very Satisfied, Satisfied, Neutral, Dissafistied, Very Dissatisfied | 3Month,6Month | 
| The change in the quality of life at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline | The change in the quality of life at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline. *Evaluate the quality of life with KARQLQ (Korean allergic rhinitis-specific quality of life questionnaire: 10 questions in regular activities at home and work, daily life disturbance and other symptoms)in the past week. | 3Month,6Month | 
| The change in the medication compliance at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline | The change in the medication compliance at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline. *Assessing the medication compliance for the last 30 days; compliance⪴80%, non-compliance<20% | 3Month,6Month | 
| Occurrence and frequency of adverse events | Occurrence and frequency of adverse events | 6Month |