Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT03014661
Status:
COMPLETED
Last Update Posted:
2017-01-09
First Post:
2017-01-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Untersuchung Zur Erfassung Und Kontrolle Der Lebensqualität Unter Einer Therapie Mit Pollinex Quattro Bei Heuschnupfen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'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': 'C516537', 'term': 'Pollinex Quattro'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-05', 'studyFirstSubmitDate': '2017-01-02', 'studyFirstSubmitQcDate': '2017-01-05', 'lastUpdatePostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life questionnaire (DLQI)', 'timeFrame': 'during year one, year two, year three of therapy or within 6 months after completion of therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pollinosis, quality of life, specific immunotherapy'], 'conditions': ['Rhinitis, Allergic, Seasonal']}, 'descriptionModule': {'briefSummary': 'Questionnaire to measure and control the quality of life of patients with hay fever who are treated or were treated with Pollinex quattro', 'detailedDescription': 'Questionnaire including 19 questions concerning the Quality of life of patients with hayfeyer under or after therapy with a specific immuntherapy with Pollinex quattro'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult persons with hayfever treated with a specific immunotherapy with Pollinex quattro plus (Allergens: birch/alder/Hazel or grass/rye or mugwort)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pollinosis/seasonal Rhinitis based on an allergy against birch/alder/Hazel pollen OR grass/rye pollen OR mugwort\n* Therapy with Polinex quattro\n\nExclusion Criteria:\n\n* Age \\<18 years.'}, 'identificationModule': {'nctId': 'NCT03014661', 'briefTitle': 'Untersuchung Zur Erfassung Und Kontrolle Der Lebensqualität Unter Einer Therapie Mit Pollinex Quattro Bei Heuschnupfen', 'organization': {'class': 'OTHER', 'fullName': 'Universität des Saarlandes'}, 'officialTitle': 'Untersuchung Zur Erfassung Und Kontrolle Der Lebensqualität Unter Einer Therapie Mit Pollinex Quattro Bei Heuschnupfen', 'orgStudyIdInfo': {'id': 'PQ-HOM-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single group study', 'description': 'Single Group study investigating retrospectively the Quality of life of patients with pollinosis under or after specific immunotherapy with Pollinex quattro', 'interventionNames': ['Other: Quality of life under or after therapy with Pollinex quattro']}], 'interventions': [{'name': 'Quality of life under or after therapy with Pollinex quattro', 'type': 'OTHER', 'description': 'To measure Quality of life using the DLQI-index in year one, year two, year three or six month after therapy with Pollinex quattro plus.', 'armGroupLabels': ['Single group study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66421', 'city': 'Homburg', 'state': 'Saarland', 'country': 'Germany', 'facility': 'Saarland University Hospital. Department of Dermatology', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität des Saarlandes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Claudia Pföhler', 'investigatorAffiliation': 'Universität des Saarlandes'}}}}