Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:46 AM
Study NCT ID:
NCT04851860
Status:
UNKNOWN
Last Update Posted:
2021-04-21
First Post:
2021-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children
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': 'D063729', 'term': 'Sublingual Immunotherapy'}], 'ancestors': [{'id': 'D003888', 'term': 'Desensitization, Immunologic'}, {'id': 'D007165', 'term': 'Immunosuppression Therapy'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'allergic rhintis children from 6 to12 years'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-14', 'studyFirstSubmitDate': '2021-04-14', 'studyFirstSubmitQcDate': '2021-04-14', 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement of serum level of platlet factor 4 before and after sublingual immunotherapy', 'timeFrame': 'baseline', 'description': 'diffrentiate serum level of platlet factor4 in children with allergic rhintis before and after treatment with sublingual immunotherapy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '27329923', 'type': 'RESULT', 'citation': 'Chen Y, Zhou L, Yang Y. Effect of sublingual immunotherapy on platelet activity in children with allergic rhinitis. Braz J Otorhinolaryngol. 2017 Mar-Apr;83(2):190-194. doi: 10.1016/j.bjorl.2016.03.006. Epub 2016 Apr 22.'}]}, 'descriptionModule': {'briefSummary': 'Better management and improving outcome of children with allergic rhinitis', 'detailedDescription': 'The prevelance of Allergic Respiratory Diseases has been increased worldwide and affect 1of 5 persons of general population . ARDs are triggered by exposure to allergen and includes allergic rhinitis with or without conjunctivitis and bronchial asthma. ARDs are associated with decreased quality of life and increased economic burden .\n\nAllergen-specific immunotherapy is the only disease modifying therapy preventing the evolution of AR to asthma, and its efficacy has long been known since observations by Leonard Noon in 1911. Allergen immunotherapy for AR is currently considered when showing strongly suggestive symptoms of AR which interfere with daily activities or sleep, and having evidence of IgE sensitization to ≥1 clinically relevant allergen .\n\nThe European Academy of Allergy and Clinical Immunology (EAACI) recommends treatmentof children with moderate to severe AR with Allergen Immunotherapy. It includes sublingual immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT).Subcutaneous immunotherapy (SCIT) has been the gold standard, whereas sublingual immunotherapy (SLIT) has emerged as an effective and safe alternative .\n\nSublingual immunotherapy (SLIT) is the only treatment that regulates the immunological process during development of allergic rhinitis (AR), rather than simply treating symptoms.\n\nPlatelet activation occurs during antigen-induced airway reactions in allergic and asthmatic subjects. Raised levels of platelet-derived mediators, such as the Platelet Factor-4 (PF4), it is observed in plasma and bronchoalveolar lavage fluid of atopic individuals, and has the ability to activate eosinophils, increase expression of Fc-IgG and Fc-IgE receptors, and stimulate basophils to release histamine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Children with moderate to severe allergic rhinitis according to Allergic Rhinitis And Its Impact On Asthma (ARIA) guidelines\\[9\\], which interfere with daily activity or sleep.\n\n 2\\. Children aged (6-12) years with clinical history of allergic rhinitis for at least one year.\n\n 3\\. Children with allergic rhinitis who failed medical treatment, desire an alternative to pharmacotherapy.\n\n 4\\. Sex : male and female.\n\nExclusion Criteria:\n\n\\- 1. Children with chronic lung \\& heart diseases as: asthma and anatomical malformation for respiratory system.\n\n2\\. disorders: Gastro Esophageal Reflux Disease, cystic fibrosis and epilepsy. 3.Children with chronic drug use: oral or nasal corticosteroids, antiepileptic and immunosuppressive.'}, 'identificationModule': {'nctId': 'NCT04851860', 'briefTitle': 'Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Effect of Sublingual Immunotherapy on Platlet factor4 Level in Children', 'orgStudyIdInfo': {'id': 'Allergic rhintis in children'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'allergic rhintis children', 'description': 'sublingual immunotherapy is used for allergic rhintis children by dosing Allergen immunotherapy extract as sublingual drops which were kept under the tongue for a couple of minutes and then swallowed. The sublingual drops were administered in the morning on an empty stomach .', 'interventionNames': ['Drug: sublingual immunotherapy']}], 'interventions': [{'name': 'sublingual immunotherapy', 'type': 'DRUG', 'description': 'sublingual immunotherapy is the only disease modifying therapy preventing the evolution of AR to asthma', 'armGroupLabels': ['allergic rhintis children']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Heba Elnaggar', 'role': 'CONTACT', 'email': 'hebanagar77@gmail.com', 'phone': '00201018038288'}, {'name': 'Eman Elbehedy', 'role': 'CONTACT', 'phone': '00201098177980'}], 'overallOfficials': [{'name': 'Mohammad Romeh', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zagazig University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor Heba', 'investigatorFullName': 'Heba Mohammad Mahmoud Mahmoud Elnaggar', 'investigatorAffiliation': 'Zagazig University'}}}}