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

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

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).

Study Overview

• Status: Completed
• Conditions: Asthma; Perennial Allergic Rhinitis

Detailed Description

A Multi-center, Prospective, Observational Study

• Study Type: Observational
• Enrollment (Actual): 2671

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • 59 institutions including Chung-Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

3,000 patients

Description

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 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

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Principal Investigator: Byoung-Whui Choi, 59 institutions including Chung-Ang University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2017
• Primary Completion (Actual): January 10, 2020
• Study Completion (Actual): July 20, 2020

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Otorhinolaryngologic Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Asthma; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
• Other Study ID Numbers: HM-MONT-OS-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No