Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 6:40 PM
Study NCT ID:
NCT01059266
Status:
COMPLETED
Last Update Posted:
2012-02-10
First Post:
2010-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PURETHAL Grasses Rush Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-09', 'studyFirstSubmitDate': '2010-01-28', 'studyFirstSubmitQcDate': '2010-01-28', 'lastUpdatePostDateStruct': {'date': '2012-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'systemic reactions > grade I or large local reactions related to injection', 'timeFrame': '24 hrs after injection'}], 'secondaryOutcomes': [{'measure': 'specific serum IgE and IgG concentrations', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['immunotherapy', 'grass pollen', 'seasonal allergy', 'dose tolerability'], 'conditions': ['Allergic Rhinitis', 'Allergic Rhinoconjunctivitis']}, 'descriptionModule': {'briefSummary': 'This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Grasses will be evaluated in a rush regimen (maximum dose reached in 3 injections during 2 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 5 weeks).\n\nThe primary parameter will be the proportion of patients who experience systemic reactions \\> grade I within 24 hours after injection or who need more than 2 additional injections during the up-dosing phase until the maintenance dose has been reached.\n\nIt is expected that up-dosing PURETHAL Grasses according to the rush regimen is as safe as using the conventional regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients with rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 \\> 70%) for at least 2 years related to grass pollen, eligible for SCIT.\n* Confirmation of IgE-mediated allergy by means of:\n\n * Positive SPT to grass pollen (mean wheal diameter ≥ 3 mm and negative control truly negative (no reaction), or\n * Specific serum IgE-test (ssIgE \\>0.7 U/ml) for grass pollen, or\n * Positive provocation test for grass pollen.\n* Age ≥ 18 years.\n* Patients have given a written informed consent\n\nExclusion Criteria:\n\n* Chronic asthma or emphysema, particularly with a FEV1 ≤ 70% of predicted value.\n* Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV).\n* Active inflammation/infection of the target organs (nose, eyes, lungs).\n* Severe atopic dermatitis in need for systemic immunosuppressive medication.\n* Symptomatic coronary heart diseases (e.g heart failure, recent myocardial infarction, unstable angina, serious arrhythmias) or severe (even under treatment) arterial hypertension.\n* Severe kidney disease.\n* Diseases with a contra-indication for the use of adrenaline.\n* Treatment with systemic or local beta-blockers or immunosuppressive drugs.\n* History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis.\n* Any specific immunotherapy (including sublingual) during the study period or during the previous 3 years for a period longer than three months.\n* Participation in a clinical study with a new investigational drug within the last three months.\n* Pregnancy, lactation or inadequate contraceptive measures (adequate measures: oral contraceptives, IUD, condom use if used together with a spermicide and having no sexual relationship with a man).\n* Alcohol or drug abuse.\n* Lack of co-operation or severe psychological disorders.\n* Completed or ongoing long-term treatment with tranquilizer or psycho active drugs.\n* Low compliance or inability to understand instructions/study documents.\n* Completed or ongoing treatment with anti-IgE-antibody.\n* Patients being in relationship or dependence with the sponsor or investigator.\n* Allergy to any of the excipients.\n* Severe illness or any other condition, which makes the patient, in the opinion of the investigator, unsuitable for the study.'}, 'identificationModule': {'nctId': 'NCT01059266', 'briefTitle': 'PURETHAL Grasses Rush Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'HAL Allergy'}, 'officialTitle': 'A Prospective, Randomized, Open, Multi-centre Study to Assess Safety of PURETHAL Grasses Given With a Rush Induction Schedule to Patients With Allergic Rhinoconjunctivitis', 'orgStudyIdInfo': {'id': 'P/0035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional regimen of PURETHAL Grasses', 'description': 'Initial treatment:\n\n6 incremental weekly subcutaneous doses of 0.05, 0.1, 0.2, 0.3, 0.4 and 0.5 ml (week 1, 2, 3, 4, 5, 6).\n\nMaintenance treatment:\n\n0.5 ml in intervals according to registered scheme (week 8, 10, 12, 16).', 'interventionNames': ['Drug: PURETHAL Grasses, 20.000 AUM/ml']}, {'type': 'EXPERIMENTAL', 'label': 'rush regimen of PURETHAL Grasses', 'description': 'Initial treatment:\n\n3 incremental weekly subcutaneous doses of 0.1, 0.3, and 0.5 ml (week 1, 2, 3)\n\nMaintenance treatment:\n\n3 monthly doses of 0.5 ml (week 7, 11, 15).', 'interventionNames': ['Drug: PURETHAL Grasses, 20.000 AUM/ml']}], 'interventions': [{'name': 'PURETHAL Grasses, 20.000 AUM/ml', 'type': 'DRUG', 'description': 'subcutaneous injections of increasing doses according to the described regimen', 'armGroupLabels': ['conventional regimen of PURETHAL Grasses', 'rush regimen of PURETHAL Grasses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitätsklinikum Bonn Klinik u. Poliklinik f. Dermatologie', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '44263', 'city': 'Dortmund', 'country': 'Germany', 'facility': 'Practice Blum', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Uni-Klinikum Carl Gustav Carus Klinik und Poliklinik für HNO', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '47051', 'city': 'Duisburg', 'country': 'Germany', 'facility': 'Practice Thieme', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': '60596', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Medaimun GmbH', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '32052', 'city': 'Herford', 'country': 'Germany', 'facility': 'Practice Wrede', 'geoPoint': {'lat': 52.11457, 'lon': 8.67343}}, {'zip': '56072', 'city': 'Koblenz', 'country': 'Germany', 'facility': 'Dr. med. Jörg Michael Nebel', 'geoPoint': {'lat': 50.35357, 'lon': 7.57883}}, {'zip': '15831', 'city': 'Mahlow', 'country': 'Germany', 'facility': 'Practice Scholz', 'geoPoint': {'lat': 52.36017, 'lon': 13.40954}}, {'zip': '41069', 'city': 'Mönchengladbach', 'country': 'Germany', 'facility': 'St. Kamillus Krankenhaus Abt. Lungen- und Bronchialheilkunde und Allergologie', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}, {'zip': '70499', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Practice Termeer', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': 'D - 65183', 'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Zentrum für Rhinologie & Allergologie', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}], 'overallOfficials': [{'name': 'Oliver Pfaar, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Zentrum für Rhinologie & Allergologie, An den Quellen 10, D - 65183 Wiesbaden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HAL Allergy', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}