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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04654702
• Other study ID #: HM-MONT-OS-01
• Status: Completed
• Start date: November 17, 2017
• Est. completion date: July 20, 2020

Study information

• Verified date: November 2021
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

A Multi-center, Prospective, Observational Study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2671
• Est. completion date: July 20, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Locations

Country	Name	City	State
Korea, Republic of	59 institutions including Chung-Ang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Occurrence and frequency of adverse events	Occurrence and frequency of adverse events	6Month