Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:45 AM
Study NCT ID:
NCT04654702
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2020-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2671}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-24', 'studyFirstSubmitDate': '2020-11-17', 'studyFirstSubmitQcDate': '2020-12-03', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in the average of TNSS at the point of Period 1 (recommended 3 Month(-1 Month)) as compared to baseline', 'timeFrame': '3 Month', 'description': 'The change in the average of TNSS at the point of Period 1 (recommended 3 Month(-1 Month)) as compared to baseline.\n\n\\*TNSS: Total symptom scores for nasal congestion, sneezing, runny nose and nasal itching during the daytime in the past week'}], 'secondaryOutcomes': [{'measure': 'The change in the average of TNSS at the point of Period 2(recommended 6Month(±1Month)) as compared to baseline', 'timeFrame': '6Month', 'description': 'The change in the average of TNSS at the point of Period 2(recommended 6Month(±1Month)) as compared to baseline'}, {'measure': 'The change in the therapeutic satisfaction at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline', 'timeFrame': '3Month,6Month', 'description': '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.\n\n\\*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"'}, {'measure': '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', 'timeFrame': '3Month,6Month', 'description': '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.\n\n\\*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.'}, {'measure': 'The change in the medication compliance at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline', 'timeFrame': '3Month,6Month', 'description': 'The change in the medication compliance at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline.\n\n\\*Assessing the medication compliance for the last 30 days; compliance⪴80%, non-compliance\\<20%'}, {'measure': 'Occurrence and frequency of adverse events', 'timeFrame': '6Month', 'description': 'Occurrence and frequency of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perennial Allergic Rhinitis', 'Asthma']}, 'descriptionModule': {'briefSummary': '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.\n\nAfter being given Monterizine capsules, Investigator evaluates the therapeutic effectiveness and safety for 3 months (or 6 months).', 'detailedDescription': 'A Multi-center, Prospective, Observational Study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '3,000 patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female aged ≥ 15 years\n2. Perennial allergic rhinitis patients with asthma who will be prescribed Monterizine capsules to treat allergic rhinitis\n3. Patients who provided a signed written informed consent form\n\nExclusion Criteria:\n\n1. Highly sensitive patients to ingredients of Monterizine capsules, hydroxyzine or piperazine derivatives\n2. Patients with renal failure(CLCR,10ml/min) and hemodialysis patients\n3. A female who is pregnant, may be pregnant, or is lactating\n4. Patients with genetic problems like Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption'}, 'identificationModule': {'nctId': 'NCT04654702', 'briefTitle': 'Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'A Multi-center, Prospective, Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap in Patients With Asthma and Perennial Allergic Rhinitis.', 'orgStudyIdInfo': {'id': 'HM-MONT-OS-01'}}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': '59 institutions including Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Byoung-Whui Choi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '59 institutions including Chung-Ang University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}