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Completed

NCT Number: NCT04654702

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

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).

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Key information

Conditions

Perennial Allergic Rhinitis Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

59 institutions including Chung-Ang University Hospital

Seoul, South Korea

About this study

A Multi-center, Prospective, Observational Study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

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

  2. The change in the therapeutic satisfaction at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline

    Time frame: 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"

  3. 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

    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.

    *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.

  4. The change in the medication compliance at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline

    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.

    *Assessing the medication compliance for the last 30 days; compliance⪴80%, non-compliance<20%

  5. Occurrence and frequency of adverse events

    Time frame: 6Month

    Occurrence and frequency of adverse events

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2020
Registry last updated
Nov 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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