Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-03-29 @ 1:53 PM
Study NCT ID:
NCT05708157
Status:
UNKNOWN
Last Update Posted:
2023-02-01
First Post:
2023-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concomitant Intranasal Antihistamine and Corticosteroid in Stepwise Treatment Strategy for Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-02-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-23', 'studyFirstSubmitDate': '2023-01-23', 'studyFirstSubmitQcDate': '2023-01-23', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TNSS', 'timeFrame': '2 week', 'description': 'total nasal symptom score'}], 'secondaryOutcomes': [{'measure': 'TOSS', 'timeFrame': '2 week', 'description': 'total nasal symptom score'}, {'measure': 'RQLQ', 'timeFrame': '2 week', 'description': 'rhinoconjunctivitis quality-of-life questionnares'}, {'measure': 'VAS', 'timeFrame': '2 week', 'description': 'visual analogue scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '35716356', 'type': 'BACKGROUND', 'citation': 'Kim M, Ryu G, Kang SY, Kim MA, Yang SI, Lee IH, Choi GS, Kim HJ, Lee SM, Kim DK, Choi JH, Yang HJ, Kim SW; Work Group for Rhinitis, the Korean Academy of Asthma, Allergy and Clinical Immunology. Intranasal antihistamine and corticosteroid to treat allergic rhinitis: A systematic review and meta-analysis. Allergy. 2022 Nov;77(11):3436-3440. doi: 10.1111/all.15415. Epub 2022 Jul 8. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Patients with perennial allergic rhinitis whose symptoms are not controlled (visual analogue scale \\[VAS\\] ≥5) by 2-week treatment with intranasal corticosteroid will receive concomitant intranasal antihistamine and corticosteroid for 2 weeks. After 2-week treatment, changes in clinical parameters including VAS, total nasal symptom score (TNSS), total ocular symptom score (TOSS), rhinoconjunctivitis quality-of-life questionnaires (RQLQ) will be evaluated.', 'detailedDescription': 'Patients with perennial allergic rhinitis whose symptoms are not controlled (visual analogue scale \\[VAS\\] ≥5) by 2-week treatment with intranasal corticosteroid will receive concomitant intranasal antihistamine and corticosteroid. In addition to VAS, total nasal symptom score (TNSS), total ocular symptom score (TOSS), rhinoconjunctivitis quality-of-life questionnaires (RQLQ) will be measured before treatment (baseline) and 2 week after treatment. The differences between parameters before treatment and those after 2-week treatment will be statistically analyzed using paired student t test, and p\\<0.05 was considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with perennial allergic rhinitis whose symptoms are not controlled by 2-week treatement with intranasal corticosteroid.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Perinnial allergic rhinitis diagnosed by a doctor\n* Positive for one or more of inhalant perinneal allergen in skin prick test or serum specific IgE measurement\n* Age: 19 years or older\n* Allergic rhinitis symptoms not controlled (VAS ≥5) by 2-week treatment with intranasal corticosteroid\n\nExclusion Criteria:\n\n* Compliance for one or more drugs in last 2 weeks: \\<80%\n* Use of oral corticosteroid, oral or intranasal decongestant in last 2 weeks\n* Initiation of allergen-specific immunotherapy in last 12 months\n* Seasonal allergic rhinitis\n* Chronic rhinosinusitis other than allergic rhinitis\n* Nasal polyposis\n* Comorbid diseases including infectious, respiratory, cardiologic, renal, gastrointestinal, endocrinologic, oncologic, hemotologic and immunologic disorders which investigators judge to affect on the study significantly.\n* Patients' rejection\n* Pregenancy or lactation"}, 'identificationModule': {'nctId': 'NCT05708157', 'acronym': 'INCS/INAH', 'briefTitle': 'Concomitant Intranasal Antihistamine and Corticosteroid in Stepwise Treatment Strategy for Allergic Rhinitis', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'Therapeutic Role of Concomitant Intranasal Antihistamine and Corticosteroid in Patient With Perennial Allergic Rhinitis Whose Symptoms Are Not Controlled With Intranasal Corticosteroid', 'orgStudyIdInfo': {'id': 'GCIRB2022-327'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Active group', 'description': 'Patients with perennial allergic rhinitis who receive concomitant intranasal antihistamine and corticosteroid.', 'interventionNames': ['Drug: concomitant intranasal antihistamine and corticosteroid']}], 'interventions': [{'name': 'concomitant intranasal antihistamine and corticosteroid', 'type': 'DRUG', 'description': 'concomitant intranasal administration with antihistamine and corticosteroid', 'armGroupLabels': ['Active group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21565', 'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Min Lee, MD, PhD', 'role': 'CONTACT', 'email': 'sangminlee77@naver.com', 'phone': '82324582713'}, {'name': 'Sang Min Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'centralContacts': [{'name': 'Sang Min Lee, MD, PhD', 'role': 'CONTACT', 'email': 'sangminlee77@naver.com', 'phone': '82324582713'}], 'overallOfficials': [{'name': 'Sang Min Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gachon University Gil Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hallym University Kangnam Sacred Heart Hospital', 'class': 'OTHER'}, {'name': 'Gangneung Asan Hospital', 'class': 'OTHER'}, {'name': 'Bundang Jesaeng Hospital', 'class': 'UNKNOWN'}, {'name': 'Chung-Ang University Gwangmyeong Hospital', 'class': 'OTHER'}, {'name': 'Hallym University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sangmin Lee, MD', 'investigatorAffiliation': 'Gachon University Gil Medical Center'}}}}