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

Completed

• Conditions: Perennial Allergic Rhinitis; Asthma

• Registration Number: NCT04654702
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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

Study Timeline

• Study Start: 2017-11-17
• Primary Completion: 2020-01-10
• Study Completion: 2020-07-20
• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-04
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-24
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2671

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in the average of TNSS at the point of Period 1 (recommended 3 Month(-1 Month)) as compared to baseline	3 Month	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

Secondary Outcome Measures

Name	Time	Method
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 average of TNSS at the point of 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(±1Month)) as compared to baseline	3Month,6Month	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"
Occurrence and frequency of adverse events	6Month	Occurrence and frequency of adverse events
The change in the medication compliance at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline	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.; \*Assessing the medication compliance for the last 30 days; compliance⪴80%, non-compliance\<20%
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	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.; \*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.

Trial Locations

Locations (1)

59 institutions including Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of