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

Hanmi Pharmaceutical Company Limited2,671 enrolled

Overview

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).

A Multi-center, Prospective, Observational Study

Study Type

OBSERVATIONAL

Enrollment

2,671

Conditions

Perennial Allergic Rhinitis Asthma

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female aged ≥ 15 years 2. Perennial allergic rhinitis patients with asthma who will be prescribed Monterizine capsules to treat allergic rhinitis 3. Patients who provided a signed written informed consent form Exclusion Criteria: 1. Highly sensitive patients to ingredients of Monterizine capsules, hydroxyzine or piperazine derivatives 2. Patients with renal failure(CLCR,10ml/min) and hemodialysis patients 3. A female who is pregnant, may be pregnant, or is lactating 4. Patients with genetic problems like Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption

Locations (1)

59 institutions including Chung-Ang University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: 3 Month

Secondary Outcomes

The change in the average of TNSS at the point of Period 2(recommended 6Month(±1Month)) as compared to baseline

Time frame: 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"

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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