Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-27 @ 11:19 PM
Study NCT ID:
NCT01061203
Status:
COMPLETED
Last Update Posted:
2016-09-08
First Post:
2010-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Grazax Asthma Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'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'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C551013', 'term': 'Grazax'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 812}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-07', 'studyFirstSubmitDate': '2010-02-01', 'studyFirstSubmitQcDate': '2010-02-01', 'lastUpdatePostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of allergy and asthma symptoms', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Quality of life and adverse events', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rhinitis', 'allergic', 'Seasonal', 'grass', 'Asthma'], 'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'Investigation of the effect of Grazax (grass tablet) on asthma prevention in children with grass pollen allergy', 'detailedDescription': 'Investigation of the effect of Grazax (ALK produced grass tablet) on asthma prevention in children with grass pollen allergy.\n\nChildren in the age of 6-12 years will be randomised to either placebo or Grazax treatment. Grazax has been approved for treatment of grass pollen allergy in adults and children, diagnosed with a positive skin prick test and/or specific immunoglobulin (IgE) test to grass pollen and with clinically relevant symptoms. This study will explore prevention of asthma in children with grass pollen induced allergy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A history of grass pollen allergy\n* Positive Skin prick test to grass\n* Positive specific IgE to grass\n\nExclusion Criteria:\n\n* Asthma'}, 'identificationModule': {'nctId': 'NCT01061203', 'acronym': 'GAP', 'briefTitle': 'Grazax Asthma Prevention', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALK-Abelló A/S'}, 'officialTitle': 'Grazax Asthma Prevention', 'orgStudyIdInfo': {'id': 'GT-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Grazax', 'description': 'Grazax tablet 75.000 SQ-T. One tablet per day for administration under the tongue.', 'interventionNames': ['Drug: Grazax']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Tablet with no active grass', 'description': 'Tablet with no active grass component. One tablet per day administered under the tongue.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Grazax', 'type': 'DRUG', 'description': 'Treatment with 75.000 SQ-T once daily', 'armGroupLabels': ['Grazax']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablet with no active grass component.', 'armGroupLabels': ['Tablet with no active grass']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20100', 'city': 'Turku', 'country': 'Finland', 'facility': 'Terveystalo Turku', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Erkka Valovirta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Terveystalo Turku, Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALK-Abelló A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}