Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 5:32 PM
Study NCT ID:
NCT00264459
Status:
COMPLETED
Last Update Posted:
2014-01-24
First Post:
2005-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen Mixture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, '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': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-23', 'studyFirstSubmitDate': '2005-12-12', 'studyFirstSubmitQcDate': '2005-12-12', 'lastUpdatePostDateStruct': {'date': '2014-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom and Medication Score (SMS)', 'timeFrame': '1.5 years of therapy', 'description': 'The primary endpoint is the change of the area under the curve (AUC, derived from an analysis period of 42 days) of the daily sum of the Symptom and Medication Score (SMS) from the baseline measurement to the measurement after 1.5 years of therapy.'}], 'secondaryOutcomes': [{'measure': 'Visual Rating Scale', 'timeFrame': '1.5 years', 'description': "Patients' Assessment of severity of symptoms at the end of each season on a 10 points visual rating scale (VRS)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sublingual immunotherapy', 'Rhinoconjunctivitis', 'Rhinitis', 'Asthma'], 'conditions': ['Grass Pollen Allergy']}, 'referencesModule': {'references': [{'pmid': '17274520', 'type': 'RESULT', 'citation': 'Worm M. Efficacy and tolerability of high dose sublingual immunotherapy in patients with rhinoconjunctivitis. Eur Ann Allergy Clin Immunol. 2006 Dec;38(10):355-60.'}, {'pmid': '18426146', 'type': 'RESULT', 'citation': 'Pfaar O, Klimek L. Efficacy and safety of specific immunotherapy with a high-dose sublingual grass pollen preparation: a double-blind, placebo-controlled trial. Ann Allergy Asthma Immunol. 2008 Mar;100(3):256-63. doi: 10.1016/s1081-1206(10)60451-6.'}], 'seeAlsoLinks': [{'url': 'http://www.allergopharma.de', 'label': 'Leader in specific allergy research and therapy'}]}, 'descriptionModule': {'briefSummary': 'The trial is performed to asses efficacy and safety of a sublingual extract of a six grass pollen mixture'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nRhinitis, Rhinoconjunctivitis, Positive Rast result to grass pollen, Positive skin prick test to grass pollen, Positive specific provocation to grass pollen,\n\nExclusion Criteria:\n\nSerious chronic diseases, Other perennial allergies'}, 'identificationModule': {'nctId': 'NCT00264459', 'briefTitle': 'Safety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen Mixture', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergopharma GmbH & Co. KG'}, 'officialTitle': 'A Multicentre, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of a Perennial Sublingual Specific Immunotherapy With a Liquid Formulation of an Extract of a Six Grass Pollen-mixture in Patients With Clinically Relevant Grass Pollen Sensitivity.', 'orgStudyIdInfo': {'id': 'Al0102st'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo was given the same way as a sublingual preparation.', 'interventionNames': ['Other: Comparator']}, {'type': 'EXPERIMENTAL', 'label': 'Liquid formulation of an extract of a 6 grass pollen mixture', 'description': 'Sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract.\n\nThe study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter. Initial treatment was applied on the first day of treatment with a starting dose of 25% of the maintenance dose. Increasing doses of 50% were applied with the second and 100% with the third dose to give the maximum (=maintenance) dose. This was followed by a daily patient selfadministered treatment with the maintenance dose.', 'interventionNames': ['Biological: Grass pollen formulation']}], 'interventions': [{'name': 'Grass pollen formulation', 'type': 'BIOLOGICAL', 'otherNames': ['specific immunotherapy'], 'description': 'Solution for sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract.\n\nThe study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.', 'armGroupLabels': ['Liquid formulation of an extract of a 6 grass pollen mixture']}, {'name': 'Comparator', 'type': 'OTHER', 'otherNames': ['Specific Immunotherapy'], 'description': 'Solution for sublingual application containing Placebo. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21465', 'city': 'Reinbek', 'country': 'Germany', 'facility': 'Allergopharma GmbH & Co. KG', 'geoPoint': {'lat': 53.51703, 'lon': 10.2488}}], 'overallOfficials': [{'name': 'Ludger Klimek, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergopharma GmbH & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}