Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT05621356
Status:
UNKNOWN
Last Update Posted:
2022-11-18
First Post:
2022-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitoring Allergen Immunotherapy in 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-10', 'studyFirstSubmitDate': '2022-11-10', 'studyFirstSubmitQcDate': '2022-11-10', 'lastUpdatePostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BAT outcome nasal fluid', 'timeFrame': '8 weeks'}, {'measure': 'BAT outcome nasal fluid', 'timeFrame': '16 weeks'}, {'measure': 'BAT outcome serum', 'timeFrame': '8 weeks'}, {'measure': 'BAT outcome serum', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'IgG4/IgA-associated inhibitory activity in nasal fluid', 'timeFrame': '8 weeks'}, {'measure': 'IgG4/IgA-associated inhibitory activity in nasal fluid', 'timeFrame': '16 weeks'}, {'measure': 'IgG4/IgA-associated inhibitory activity in serum', 'timeFrame': '8 weeks'}, {'measure': 'IgG4/IgA-associated inhibitory activity in serum', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immunotherapy', 'Rhinitis, Allergic', 'Treatment Outcome']}, 'descriptionModule': {'briefSummary': 'Allergic rhinitis (hay fever) can be treated successfully with allergen-specific immunotherapy (AIT) for 3-5 years. This relative expensive and prolonged treatment is not suitable for everyone and therefore it is important to predict who will benefit from this therapy early after the start of treatment.\n\nThis project will investigate whether a BAT with nasal fluid can detect inhibition during immunotherapy in comparison with a BAT with blood.', 'detailedDescription': 'Allergic rhinitis (hay fever) can be treated successfully with allergen-specific immunotherapy (AIT) for 3-5 years. This relative expensive and prolonged treatment is not suitable for everyone and therefore it is important to predict who will benefit from this therapy early after the start of treatment. Biomarkers, like Basophil Activation Test (BAT) and IgE-facilitated allergen binding (FAB), using nasal fluid instead of blood, probably better reflect therapy effect (inhibition of an IgE-mediated allergic reaction) as the nose is the main target organ for AIT in allergic rhinitis.\n\nThis project will investigate whether a BAT with nasal fluid can detect inhibition during immunotherapy in comparison with a BAT with blood. Nasal fluid and blood samples are collected at baseline and after 8 and 16 weeks of treatment. A nasal fluid inhibition BAT is developed and validated by comparison with a BAT using serum and an IgE-FAB assay.\n\n15 adults with birch pollen allergy, who are treated with AIT (Itulazax birch pollen tablet) and 10 adults with birch pollen allergy, who are treated with immunosuppressive medication (control group) will be included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Birch pollen allergic patients who are treated with Itulazax (birch pollen SLIT-tablet) and birch pollen allergic patients who are treated with immunosuppressive medication (control group).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IgE-sensitized birch pollen allergy\n* Start of Itulazax therapy or immunosuppressive therapy (nasal corticosteroid and/or antihistamine eye drops)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Other underlying chronic conditions (immunological (autoimmune or immunodeficiency), oncological)\n* Unstable uncontrolled asthma\n* Smoking'}, 'identificationModule': {'nctId': 'NCT05621356', 'briefTitle': 'Monitoring Allergen Immunotherapy in Allergic Rhinitis', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': 'Monitoring Allergen Immunotherapy in Allergic Rhinitis; is Nasal Fluid the Way to Precision Medicine?', 'orgStudyIdInfo': {'id': '2021-1924'}, 'secondaryIdInfos': [{'id': 'NL78278.091.21', 'type': 'OTHER', 'domain': 'CCMO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'allergen-specific immunotherapy (AIT)', 'description': 'Adults with birch pollen allergy, who are treated with allergen-specific immunotherapy (AIT)', 'interventionNames': ['Other: A nasal fluid Basophil Activation Test (BAT)']}, {'label': 'control', 'description': 'Adults with birch pollen allergy, who are treated with immunosuppressive medication', 'interventionNames': ['Other: A nasal fluid Basophil Activation Test (BAT)']}], 'interventions': [{'name': 'A nasal fluid Basophil Activation Test (BAT)', 'type': 'OTHER', 'description': 'a BAT technique for monitoring the inhibitory effect of nasal fluid on basophil activation.', 'armGroupLabels': ['allergen-specific immunotherapy (AIT)', 'control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6815 AD', 'city': 'Arnhem', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Janneke Ruinemans-Koerts', 'role': 'CONTACT', 'phone': '0031 88 005 8888'}], 'facility': 'Rijnstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}], 'centralContacts': [{'name': 'Janneke Ruinemans-Koerts', 'role': 'CONTACT', 'email': 'j.ruinemans-koerts@rijnstate.nl', 'phone': '0031 88 005 8888'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wageningen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}