Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-01 @ 8:30 AM
Study NCT ID:
NCT00841256
Status:
COMPLETED
Last Update Posted:
2015-10-16
First Post:
2008-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Trial of Sublingual Immunotherapy With a Solution of Grass Pollen Allergen Extract in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-15', 'studyFirstSubmitDate': '2008-04-22', 'studyFirstSubmitQcDate': '2009-02-10', 'lastUpdatePostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of Symptom-Medication-Score', 'timeFrame': 'After 1 year of treatment', 'description': 'The change of the area under the curve of the symptom and medication score (SMS) from the baseline season to the season after 1 year of treatment.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the documentation of adverse events (AEs)', 'timeFrame': 'Entire treatment period', 'description': 'Safety of treatments during the entire treatment period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['specific immunotherapy', 'SIT', 'SLIT', 'sublingual'], 'conditions': ['Allergic Rhinoconjunctivitis']}, 'referencesModule': {'references': [{'pmid': '22939758', 'type': 'RESULT', 'citation': 'Wahn U, Klimek L, Ploszczuk A, Adelt T, Sandner B, Trebas-Pietras E, Eberle P, Bufe A; SLIT Study Group. High-dose sublingual immunotherapy with single-dose aqueous grass pollen extract in children is effective and safe: a double-blind, placebo-controlled study. J Allergy Clin Immunol. 2012 Oct;130(4):886-93.e5. doi: 10.1016/j.jaci.2012.06.047. Epub 2012 Aug 29.'}], 'seeAlsoLinks': [{'url': 'http://www.allergopharma.de', 'label': 'Leader in specific allergy research and therapy'}, {'url': 'https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-005911-82/DE', 'label': 'Click here for information about this trial in the European Clinical Trials Register'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of safety and efficacy of sublingual immunotherapy with grass pollen allergens formulated as solution in comparison to a symptomatic standard treatment with add on placebo in grass pollen allergic children suffering from allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma.', 'detailedDescription': 'Although highly effective, subcutaneous administration of allergens may cause inconvenience in some patients. Alternative routes, e.g. nasal and oral, have therefore been investigated to find an immunotherapy regimen largely accepted by all groups of patients, including children.\n\nSublingual specific immunotherapy (SLIT) may represent a more acceptable route of immunotherapy. It may be an optimal therapy option especially for children because they often fear injections.\n\nIn this study children are to be treated with a preparation of a grass pollen allergen extract in a water/glycerol solution with phosphate buffered saline in comparison to a symptomatic standard treatment with add on placebo, in order to investigate efficacy and safety of the study drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 4 - \\<12 years (at the time of inclusion)\n* Positive SPT\n* Positive EAST\n* Positive CPT\n\nExclusion Criteria:\n\n* Serious chronic diseases\n* Other perennial allergies'}, 'identificationModule': {'nctId': 'NCT00841256', 'briefTitle': 'Multicenter Trial of Sublingual Immunotherapy With a Solution of Grass Pollen Allergen Extract in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergopharma GmbH & Co. KG'}, 'officialTitle': '... Study to Evaluate Efficacy and Safety of Perennial Sublingual SIT With a Solution of Grass Pollen Allergen ... in Children With Clinically Relevant Grass Pollen Sensitivity in Comparison to a ... Standard Treatment With Add on Placebo', 'orgStudyIdInfo': {'id': 'AL0506st'}, 'secondaryIdInfos': [{'id': '2006-005911-82', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immunotherapy', 'description': 'Grass pollen allergens in a water/glycerol solution', 'interventionNames': ['Biological: Grass pollen allergens in a water/glycerol solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Water/glycerol solution with phosphate buffered saline', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Grass pollen allergens in a water/glycerol solution', 'type': 'BIOLOGICAL', 'otherNames': ['Allerslit forte grasses'], 'description': 'In total up to 4 drops (dose for maintenance therapy) are administered under the tongue.', 'armGroupLabels': ['Immunotherapy']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Comparator'], 'description': 'Placebo was given in the same way as the sublingual active treatment. Symptomatic standard treatment, i.e. antihistamines and glucocorticoids as well as alphamimetics is allowed during grass pollen season.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Klinik für Paediatrie Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Ulrich Wahn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergopharma GmbH & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}