Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
Study NCT ID:
NCT06741800
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-19
First Post:
2024-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microbial Study of Sublingual Immunotherapy Tablets in Patients With 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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'elbow venous blood: 2ml, feces: 5ml, saliva:2ml, tonsil microorganism:2ml, nasal exfoliated cells:2ml, nasal microorganism:2ml.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2032-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2024-01-22', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)', 'timeFrame': '2024.2-2026.7', 'description': 'Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure'}, {'measure': 'Visual analogue scale (VAS)', 'timeFrame': '2024.2-2026.7', 'description': 'Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure. Range: 0-10. Higher scores reflect more pain and severity.'}, {'measure': 'Total Nasal Symptom Score (TNSS)', 'timeFrame': '2024.2-2026.7', 'description': 'It includes four common nasal symptoms: itching, nasal congestion, sneezing and runny nose. These four symptoms are scored using a "four-point scale," in which the severity of each symptom is rated from 0 to 3. The total score for the entire TNSS score is the sum of the four symptom scores, which range from 0 to 12.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rhinitis, Allergic']}, 'descriptionModule': {'briefSummary': 'The incidence of allergic rhinitis (AR) in Chinese adults was reported to be as high as 24.1% and 16.8% in children. The current symptomatic treatment has the disadvantage of poor efficacy and cannot change the natural course of the disease. Allergen immunotherapy (AIT) is the only causative treatment approved by the WHO, bringing a new option to patients with allergic diseases. The quality of allergen preparations is critical to the diagnosis and treatment of the disease, emphasizing the need for standardized preparations, and AIT treatment in the early stages of the disease may change the long-term progression of the disease. Recent studies have reported that the microbiome of patients with different efficacy of desensitization therapy is different and may be correlated with the clinical symptoms of patients, but no prospective studies have been reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with allergic rhinitis in the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University and selected sublingual tablet desensitization.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18-65 years).\n* Patients with moderate to severe dust mite allergic rhinitis were diagnosed based on clinical history and positive dust mite sensitization tests (skin prick test and/or specific IgE).\n* Patients who visited the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University and selected sublingual tablet desensitization.\n\nExclusion Criteria:\n\n* Patients who refused to accept specimen and questionnaire collection.\n* Patients who had nasal diseases other than allergic rhinitis, such as nasal papilloma and nasal malignant tumor.'}, 'identificationModule': {'nctId': 'NCT06741800', 'briefTitle': 'Microbial Study of Sublingual Immunotherapy Tablets in Patients With Allergic Rhinitis', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'Microbial Characterization in Patients With Allergic Rhinitis Before and After Sublingual Immunotherapy Tablets', 'orgStudyIdInfo': {'id': '2023-SR-528'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients desensitized by sublingual tablets', 'interventionNames': ['Drug: ACARIZAX®️']}], 'interventions': [{'name': 'ACARIZAX®️', 'type': 'DRUG', 'description': 'ACARIZAX®️：The recommended dose for adults (18-65 years) is one freeze-dried tablet (12 SQ-HDM) daily, placed under the tongue.', 'armGroupLabels': ['Patients desensitized by sublingual tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Lei Cheng, PhD', 'role': 'CONTACT', 'email': 'chenglei@jsph.org.cn', 'phone': '13776620807', 'phoneExt': '0086'}], 'facility': 'The First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Lei Cheng, PhD', 'role': 'CONTACT', 'email': 'chenglei@jsph.org.cn', 'phone': '13776620807', 'phoneExt': '0086'}], 'overallOfficials': [{'name': 'Lei Cheng, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}