Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-29 @ 8:23 AM
Study NCT ID:
NCT06021912
Status:
UNKNOWN
Last Update Posted:
2023-09-01
First Post:
2023-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
e-ITAG Allergen Immunotherapy in the Management of Allergic Asthma
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': 'D007167', 'term': 'Immunotherapy'}], 'ancestors': [{'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-26', 'studyFirstSubmitDate': '2023-08-26', 'studyFirstSubmitQcDate': '2023-08-26', 'lastUpdatePostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in IGG1, IGG4', 'timeFrame': 'After 6 month of ITA', 'description': 'increase in IGG1, IGG4 after ITA treatment compared to conventional treatment group (prik test /ratio of IGE/IG4/ rate of significant increase is \\> 25%.'}, {'measure': 'Deacresed basophil activation', 'timeFrame': 'After 6 month of ITA', 'description': 'activation of basophils by the presence of the CD203c marker in the ITA group compared with the conventional treatment group'}], 'secondaryOutcomes': [{'measure': 'Evalution AQLQS score(QUALITY OFLIFE)', 'timeFrame': 'After 6 month of ITA', 'description': 'Assessing the quality of life in asthma patient by AQLQS score/ ACQ/ ARIA'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ITA ASTHMA ALLERGIC RHINITIS'], 'conditions': ['Study the Efficacy of ITA in Patients With Allergic Asthma or Allergic Rhinitis or Allergic Rhinitis Compared With Conventional Treatment']}, 'descriptionModule': {'briefSummary': 'Allergy is defined as a specific abnormal and excessive reaction of the immune system to exposed allergen .\n\nThis reaction is reproducible with each new exposure allergen . A recent study by The European Academy of Allergy and Clinical Immunology" (EAACI) estimates that 30% of the population suffers from allergic rhinitis and/or conjunctivitis, 20% of children suffer from asthma, and 8% of the population suffers from food allergies in Europe, with a clear increase in prevalence.\n\nAllergenic immunotherapy (AIT) remains a corner stone in the treatment of allergic diseases. It involves administering an increasing dose of allergens to induce immunological tolerance. The efficacy and safety of ITA have already been demonstrated. However, patient response is highly heterogeneous. This findinf illustrates the value of biomarkers in the selection of patients, enabling prediction of response to ITA and follow-up.', 'detailedDescription': 'This is a prospective, observationel study conducted in Pneumology Department at the Military Hospital in collaboration with the Immunology Laboratory\n\nWe followed patients in 2 groups:\n\nGroup 1: patients with asthma or allergic rhinitis who had received allergen immunotherapy (AIT). Group 2: patients with asthma or allergic rhinitis who received a conventional treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with symptoms of Asthma or moderate or severe persistent allergic rhinitis allergic rhinitis, with a positive prick test or specific IgE', 'eligibilityCriteria': "Inclusion Criteria Patients with symptoms of Asthma or moderate or severe persistent allergic rhinitis allergic rhinitis, with a positive prick test or specific IgE assay demonstrating the presence of allergens (1 or 2 allergens). A significant impact on the patient's quality of life Rhinitis associated with tracheitis or mild-to-moderate asthma. Patients with poorly controlled asthma despite optimal treatment Ineffective drug treatment Patients willing to adhere to our research protocol\n\nExclusion Criteria:\n\nPatients with multi-allergenic asthma (more than 2 allergens) Pregnancy (at the time of ITA initiation). Autoimmune disease Immunosuppressive treatment Poorly controlled asthma HIV infection Cancer Severe psychiatric disorders. Cardiovascular diseases with a risk of complications during administration of adrenaline. Use of beta-blockers. Treatment with ACE inhibitors. Persistent lesions of the oral mucosa (chronic oral aphthosis periodontitis, etc.). Worsening of rhinitis. Acute febrile state. Recent administration of another vaccine (in this case, the ITA should not be administered on the same day).\n\nITA should not be administered on the same day)."}, 'identificationModule': {'nctId': 'NCT06021912', 'acronym': 'EITAG', 'briefTitle': 'e-ITAG Allergen Immunotherapy in the Management of Allergic Asthma', 'organization': {'class': 'NETWORK', 'fullName': 'General Administration of Military Health, Tunisia'}, 'officialTitle': 'Evaluating the Efficacy of Allergen Immunotherapy in the Management of Allergic Asthma and Rhinitis', 'orgStudyIdInfo': {'id': 'efficacity of EITAG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ITA GROUP', 'description': 'Patients with asthma or allergic rhinitis who have received allergen immunotherapy (ITA).', 'interventionNames': ['Drug: Immunotherapy']}, {'label': 'STANDARD TREATMENT', 'description': 'patients with asthma or allergic rhinitis who have received standard allergen treatment.', 'interventionNames': ['Drug: Immunotherapy']}], 'interventions': [{'name': 'Immunotherapy', 'type': 'DRUG', 'description': 'Sublingual immunotherapy', 'armGroupLabels': ['ITA GROUP', 'STANDARD TREATMENT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1008', 'city': 'Tunis', 'state': 'Montfleury', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'Hedi Gharsallah, MD', 'role': 'CONTACT', 'email': 'gharsallahhedi@gmail.com', 'phone': '71391885', 'phoneExt': '00216'}, {'name': 'Salsabil Daboussi, MD', 'role': 'CONTACT', 'email': 'selsabilhmpit@gmail.com', 'phone': '71391133', 'phoneExt': '00216'}], 'facility': 'Military Hospital of Tunis', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'centralContacts': [{'name': 'SELSABIL DABOUSSI, MD', 'role': 'CONTACT', 'email': 'selsabilhmpit@gmail.com', 'phone': '21629424692', 'phoneExt': '19358'}], 'overallOfficials': [{'name': 'SELSABIL DABOUSSI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pneumologie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Administration of Military Health, Tunisia', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DR SELSABIL Daboussi', 'investigatorFullName': 'Hedi Gharsallah', 'investigatorAffiliation': 'General Administration of Military Health, Tunisia'}}}}