Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 4:04 AM
Study NCT ID:
NCT01199133
Status:
TERMINATED
Last Update Posted:
2025-02-11
First Post:
2010-09-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000485', 'term': 'Allergens'}], 'ancestors': [{'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mroux@stallergenes.com', 'phone': '+33 (0) 1 55 59 29 70', 'title': 'Michel Roux, Medical Director', 'organization': 'Stallergenes'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Reporting and collection of Adverse Events go from the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period, a total of 13 months.', 'description': 'Treatment Emergent Adverse Event (TEAE) defined as any Adverse Event which started on or after the date of the first administration of investigational product up to the 30th day (inclusive) after the last administration in Year 1 treatment period.\n\nA treatment Emergent Adverse Event is not necessarily a treatment related adverse event. "Treatment Emergent" refers to temporality, not to causality.', 'eventGroups': [{'id': 'EG000', 'title': '300 IR', 'description': '300 IR house dust mites allergen extract tablet', 'otherNumAtRisk': 241, 'otherNumAffected': 149, 'seriousNumAtRisk': 241, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo tablet', 'otherNumAtRisk': 230, 'otherNumAffected': 124, 'seriousNumAtRisk': 230, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 36}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Oral pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Tooth loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Tongue oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}], 'seriousEvents': [{'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Ligament injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Status asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Gastroenteritis salmonella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Adjustment disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}, {'term': 'Varicocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1.'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Adjusted Symptom Score (AASS) During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '300 IR', 'description': '300 IR house dust mites allergen extract tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '2.85', 'spread': '0.160', 'groupId': 'OG000'}, {'value': '2.84', 'spread': '0.155', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '> 0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.43', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Year 1 Primary Period = 01 OCT to 30 NOV 2010 The value was obtained by averaging the daily scores over the primary period', 'description': 'The primary efficacy endpoint was the Average Adjusted Symptom Score (AAdSS) during the period from 1 October 2010 to 30 November 2010 (Year 1 Primary Period) assessed in the Full Analysis Set defined for Year 1. The Average Adjusted Symptom Score (AAdSS) ranges from 0 to 12, with a higher score meaning a worse outcome.\n\nIt is a score assessing four rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, adjusted on the rescue medication intake', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set included all randomized patients who received at least one dose of study treatment and had at least one evaluation of Adjusted Symptom Score (AdSS) during the treatment Year 1 period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '300 IR', 'description': '300 IR house dust mites allergen extract tablet'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo tablet'}], 'periods': [{'title': 'Year 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '241'}, {'groupId': 'FG001', 'numSubjects': '230'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}, {'groupId': 'FG001', 'numSubjects': '215'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Any other reason not above-mentioned', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}, {'title': 'Year 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}, {'groupId': 'FG001', 'numSubjects': '215'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '212'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Any other reason not above-mentioned', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'First Patient First Visit 27 OCT 2009, Last Patient Last Visit 30 SEP 2011'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '443', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '300 IR', 'description': '300 IR house dust mites allergen extract tablet'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo tablet'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'spread': '3.24', 'groupId': 'BG000'}, {'value': '11.2', 'spread': '3.41', 'groupId': 'BG001'}, {'value': '11.1', 'spread': '3.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Full Analysis Set included all randomized patients who received at least one dose of study treatment and had at least one evaluation of Adjusted Symptom Score (AdSS) during the treatment Year 1 period.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 471}}, 'statusModule': {'whyStopped': 'Study population was insufficiently symptomatic to enable evaluation of the efficacy of the treatment. No safety concern.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2010-09-09', 'resultsFirstSubmitDate': '2024-11-27', 'studyFirstSubmitQcDate': '2010-09-09', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-23', 'studyFirstPostDateStruct': {'date': '2010-09-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Adjusted Symptom Score (AASS) During the Treatment Period', 'timeFrame': 'Year 1 Primary Period = 01 OCT to 30 NOV 2010 The value was obtained by averaging the daily scores over the primary period', 'description': 'The primary efficacy endpoint was the Average Adjusted Symptom Score (AAdSS) during the period from 1 October 2010 to 30 November 2010 (Year 1 Primary Period) assessed in the Full Analysis Set defined for Year 1. The Average Adjusted Symptom Score (AAdSS) ranges from 0 to 12, with a higher score meaning a worse outcome.\n\nIt is a score assessing four rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, adjusted on the rescue medication intake'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Allergic Rhinitis Due to Dust Mite']}, 'referencesModule': {'references': [{'pmid': '39035788', 'type': 'DERIVED', 'citation': 'Worm M, Demoly P, Okamoto Y, Vidal C, Daghildjian K, Yan K, Casale TB, Bergmann KC. Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data. World Allergy Organ J. 2024 Jun 25;17(7):100924. doi: 10.1016/j.waojou.2024.100924. eCollection 2024 Jul.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy (SLIT) administered to children and adolescents as allergen-based tablets once daily over a period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication use.', 'detailedDescription': 'After the screening period, the patients will be administered 300 IR house dust mite allergen based tablets or placebo, once a day, for a period of 36 months with two windows of 8 months and 6 months without treatment. The carry over effect will be evaluated after a treatment free follow up period of 24 months.\n\nAn independent Data Monitoring Committee will be constituted to evaluate the efficacy and safety data at the end of Year 1 and Year 3, and the post-treatment long-term efficacy data at the end of year 4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female outpatients, aged 5-17 years inclusive\n* History of house dust mite-related allergic rhinitis for at least 1 year requiring regular intake of symptomatic treatment(s)\n* Sensitised to D. pteronyssinus and/or D. farinae (positive skin prick test with wheal diameter greater than 3 mm and specific IgE level ≥ 0.7 kU/L)\n\nExclusion Criteria:\n\n• Co-sensitization associated with clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites to which the patient will be exposed during the study, i.e. will notably be excluded\n\n* patients sensitised to cat or dog allergens and regularly exposed to these allergens\n* patients sensitised to aspergillus, cladosporium, alternaria\n* patients sensitised to parietaria , ragweed, or mugwort, if this allergen is endemic to the region'}, 'identificationModule': {'nctId': 'NCT01199133', 'briefTitle': 'Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stallergenes Greer'}, 'officialTitle': 'A Randomised,Double-blind,Placebo-controlled,Multi National,Phase III Trial to Assess the Efficacy and Safety of 300 IR Sublingual Immunotherapy Administered as Allergen-based Tablets Once Daily to Adolescents and Children Above the Age of 5 Years, Suffering From House Dust Mite Allergic Rhinitis', 'orgStudyIdInfo': {'id': 'VO64.08'}, 'secondaryIdInfos': [{'id': '2009-011999-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '300 IR', 'description': '300 IR house dust mites allergen extract tablet', 'interventionNames': ['Drug: 300 IR house dust mites allergen extract tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablet', 'interventionNames': ['Drug: Placebo tablet']}], 'interventions': [{'name': '300 IR house dust mites allergen extract tablet', 'type': 'DRUG', 'otherNames': ['House dust mites (Der p and Der f) allergen extract tablet'], 'description': 'One sublingual tablet daily for one year.', 'armGroupLabels': ['300 IR']}, {'name': 'Placebo tablet', 'type': 'DRUG', 'otherNames': ['Sublingual placebo tablet'], 'description': 'One sublingual tablet daily for one year.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ulrich Wahn, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Charite- Campus Virchow klinikum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stallergenes Greer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}