Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:38 PM
Study NCT ID:
NCT04389034
Status:
COMPLETED
Last Update Posted:
2021-02-08
First Post:
2020-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Specific Immunotherapy With Pollinex Quattro (Tree-/Grass Pollen) on Allergen-specific Immunoglobulin E (IgE) Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D003233', 'term': 'Conjunctivitis, 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': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C516537', 'term': 'Pollinex Quattro'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-05', 'studyFirstSubmitDate': '2020-04-22', 'studyFirstSubmitQcDate': '2020-05-11', 'lastUpdatePostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in allergen specific IgE after allergen-specific immunotherapy', 'timeFrame': 'baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)', 'description': 'Efficacy'}], 'secondaryOutcomes': [{'measure': 'Change in medication usage after allergen-specific immunotherapy', 'timeFrame': 'baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)', 'description': 'Efficacy'}, {'measure': 'Change in FEV1 (forced expiratory volume at one second; measured in %) after allergen-specific immunotherapy', 'timeFrame': 'baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)', 'description': 'Efficacy'}, {'measure': 'Change in lung function resistance (measured in Kpa/l/s) after allergen-specific immunotherapy', 'timeFrame': 'baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)', 'description': 'Efficacy'}, {'measure': 'Assessment of allergic eye symptoms (itching, tearing, redness, feeling of pressure) , on a scale 0 -10 (none - severe) after allergen-specific immunotherapy', 'timeFrame': 'baseline, post-treatment, at least 3 years of allergen-specific immunotherapy', 'description': 'Efficacy'}, {'measure': 'Assessment of allergic nasal symptoms (rhinorrhea, nasal obstruction) , on a scale 0 -10 (none - severe) after allergen-specific immunotherapy', 'timeFrame': 'baseline, post-treatment, at least 3 years of allergen-specific immunotherapy', 'description': 'Efficacy'}, {'measure': 'Assessment of allergic lung/bronchial symptoms (shortness of breath, cough), on a scale 0 -10 (none - severe) after allergen-specific immunotherapy', 'timeFrame': 'baseline, post-treatment, at least 3 years of allergen-specific immunotherapy', 'description': 'Efficacy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rhinitis, Allergic', 'Respiratory Tract Infections', 'Allergy', 'Allergic Asthma', 'Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'Primary goal of this non-interventional study is to evaluate the change in level of allergen-specific IgE (EAST class) after allergen-specific immunotherapy with Pollinex Quattro with tree and/or grass pollen extracts and their mixtures under medial routine at adults with tree- and/or grass-medicated pollinosis.', 'detailedDescription': 'In this non-interventional study, the change in level of allergen-specific IgE before and after 3 or more years of allergen-specific immunotherapy with Pollinex Quattro in a patient population with tree and/or grass pollen induced pollinosis and/or asthma will be analyzed. In addition, the change in medication usage, asthma status for asthmatic patients after 3, 4 or 5 years of allergen specific immunotherapy will be evaluated. Furthermore, patients will be asked for their change in quality of life after therapy end.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Allergic patients ≥ 18 years with IgE-mediated rhinitis, conjunctivitis and bronchial asthma on grass and/or tree pollen', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years\n* Diagnosis of IgE-mediated rhinitis, conjunctivitis and bronchial asthma on grass and/or tree pollen\n* completed allergen-specific immunotherapy with Pollinex Quattro with tree and/or grass pollen extracts or their mixtures according to SMPC effective during immunotherapy\n\nExclusion Criteria:\n\n* Contraindication according to Summary of Product Characteristics (SMPC) effective during immunotherapy\n* no additional allergen-specific immunotherapy with another product than Pollinex Quattro'}, 'identificationModule': {'nctId': 'NCT04389034', 'briefTitle': 'Influence of Specific Immunotherapy With Pollinex Quattro (Tree-/Grass Pollen) on Allergen-specific Immunoglobulin E (IgE) Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergy Therapeutics'}, 'officialTitle': 'Retrospective Data Collection Based on Patient Records and Questionaire Based Data of Therapy Results of Allergen-specific Immunotherapy With Pollinex Quattro With Tree and/or Gras Pollen Extracts and Their Mixtures', 'orgStudyIdInfo': {'id': 'PQ EAST V1.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults', 'description': 'Patients with IgE-induced Rhinitis, Conjunctivitis and/or asthma due to tree- and/or grass pollen induced allergy', 'interventionNames': ['Drug: Pollinex Quattro with tree- and grass pollen extracts and their mixtures']}], 'interventions': [{'name': 'Pollinex Quattro with tree- and grass pollen extracts and their mixtures', 'type': 'DRUG', 'description': 'retrospective analysis of patient records of allergen-specific immunotherapy', 'armGroupLabels': ['Adults']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cologne', 'country': 'Germany', 'facility': 'Outpatient Center Dr Stollewerk/Niebecker', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergy Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}