Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT02255604
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2014-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Intralymphatic Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020794', 'term': 'Receptor Protein-Tyrosine Kinases'}], 'ancestors': [{'id': 'D011505', 'term': 'Protein-Tyrosine Kinases'}, {'id': 'D011494', 'term': 'Protein Kinases'}, {'id': 'D017853', 'term': 'Phosphotransferases (Alcohol Group Acceptor)'}, {'id': 'D010770', 'term': 'Phosphotransferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Hans.Jurgen.Hoffmann@ki.au.dk', 'phone': '7845000', 'title': 'Hans Jürgen Hoffmann', 'organization': 'Aarhus Universitets Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.\n\nPatients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015.\n\nAlk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 4', 'otherNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '3 Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.\n\nPatients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection.\n\nalk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 3 injection into a lymphnode', 'otherNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'no Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline.\n\nPatients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control.\n\n0.1 ml Isoton saline: 4 injection into a lymphnode', 'otherNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Local reaction', 'notes': 'Local swelling, edema and rubor at injection point', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Headache, fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anaphylaxis', 'notes': 'anaphylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in cSMS (Combined Symptom and Medication Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.\n\nPatients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015.\n\nAlk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 4'}, {'id': 'OG001', 'title': '3 Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.\n\nPatients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection.\n\nalk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 3 injection into a lymphnode'}, {'id': 'OG002', 'title': 'no Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline.\n\nPatients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control.\n\n0.1 ml Isoton saline: 4 injection into a lymphnode'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '3.4'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '3.0'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'cSMS, Combined symptom and medication score, during grass pollen season in three years follow up.\n\nMinimal score 0, Maximal score 18. Higher score means worse outcome.\n\nScale:\n\nItchy/red eys: 0-3, Runny eyes: 0-3, Itchy nose: 0-3, Runny nose: 0-3, Block nose: 0-3, Sneezes: 0-3. Topical antihistamine 1.5 points/1 point. Nasal corticosteroid: 1 point/2 points. Oral antihistamine: 6 points/1 point. Oral prednisolon 1.5 point /3 points.\n\nElements are summed to a combined score. Different combination methods exists. EAACI recommends means, i.e. symptoms 0-3 plus medicationscore 0-3. This scoringsystem was applied in the last follow-up year.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Circulating Grass Specific Immunoglobulin E Producing Plasmacells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.\n\nPatients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015.\n\nAlk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 4'}, {'id': 'OG001', 'title': '3 Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.\n\nPatients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection.\n\nalk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 3 injection into a lymphnode'}, {'id': 'OG002', 'title': 'no Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline.\n\nPatients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control.\n\n0.1 ml Isoton saline: 4 injection into a lymphnode'}], 'timeFrame': 'one week from vaccinations', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to technical flow-cytometry problem could analysis of circulating grass specific immunoglobulin E producing plasma cells not be performed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Basophil Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.\n\nPatients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015.\n\nAlk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 4'}, {'id': 'OG001', 'title': '3 Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.\n\nPatients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection.\n\nalk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 3 injection into a lymphnode'}, {'id': 'OG002', 'title': 'no Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline.\n\nPatients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control.\n\n0.1 ml Isoton saline: 4 injection into a lymphnode'}], 'timeFrame': '2 years', 'description': 'Flowcytometry based analysis of basophil cells reaction to allergen provocation.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to technical problems data was not recorded at all time points and results are missing.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.\n\nPatients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015.\n\nAlk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 4'}, {'id': 'FG001', 'title': '3 Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.\n\nPatients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection.\n\nalk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 3 injection into a lymphnode'}, {'id': 'FG002', 'title': 'no Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline.\n\nPatients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control.\n\n0.1 ml Isoton saline: 4 injection into a lymphnode'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.\n\nPatients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015.\n\nAlk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 4'}, {'id': 'BG001', 'title': '3 Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.\n\nPatients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection.\n\nalk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.: 3 injection into a lymphnode'}, {'id': 'BG002', 'title': 'no Intralymphatic Immune Therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline.\n\nPatients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control.\n\n0.1 ml Isoton saline: 4 injection into a lymphnode'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.67', 'spread': '5.52', 'groupId': 'BG000'}, {'value': '29.92', 'spread': '6.80', 'groupId': 'BG001'}, {'value': '30.58', 'spread': '7.43', 'groupId': 'BG002'}, {'value': '30.72', 'spread': '6.58', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2014-09-17', 'resultsFirstSubmitDate': '2020-11-10', 'studyFirstSubmitQcDate': '2014-09-29', 'lastUpdatePostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-24', 'studyFirstPostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Basophil Sensitivity', 'timeFrame': '2 years', 'description': 'Flowcytometry based analysis of basophil cells reaction to allergen provocation.'}], 'primaryOutcomes': [{'measure': 'Change in cSMS (Combined Symptom and Medication Score)', 'timeFrame': '3 years', 'description': 'cSMS, Combined symptom and medication score, during grass pollen season in three years follow up.\n\nMinimal score 0, Maximal score 18. Higher score means worse outcome.\n\nScale:\n\nItchy/red eys: 0-3, Runny eyes: 0-3, Itchy nose: 0-3, Runny nose: 0-3, Block nose: 0-3, Sneezes: 0-3. Topical antihistamine 1.5 points/1 point. Nasal corticosteroid: 1 point/2 points. Oral antihistamine: 6 points/1 point. Oral prednisolon 1.5 point /3 points.\n\nElements are summed to a combined score. Different combination methods exists. EAACI recommends means, i.e. symptoms 0-3 plus medicationscore 0-3. This scoringsystem was applied in the last follow-up year.'}], 'secondaryOutcomes': [{'measure': 'Change in Circulating Grass Specific Immunoglobulin E Producing Plasmacells', 'timeFrame': 'one week from vaccinations'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Allergic Rhinitis', 'Allergen immunotherapy'], 'conditions': ['Allergy', 'Immune Tolerance', 'Injection Site Discomfort']}, 'descriptionModule': {'briefSummary': 'The investigators want to investigate whether specific immunotherapy can be delivered directly into a lymph node. The investigators think that a direct introduction of allergen to the antigen presenting cells in the lymph node a give a strong immune response and that this can change the number of injections needed in allergen immunotherapy. The investigators do measurements of clinical effect and a variety of paraclinical test to see if the investigators can find af biomarker of successful specific immune therapy of grass allergy.', 'detailedDescription': 'Patients are injected with 3 or 4 doses of alk 225 Phleum Pratense 1000 standard quantity units/ml in a lymph node in the groin.\n\nThe investigators monitor clinical response and use of medication during the grass pollen season. SMS (Symptom and Medication Score) will be used.\n\nThe investigators count the number of immunoglobulin E grass producing plasma cells in blood one week after each injection. The investigators also do basophil activation tests, nasal provocation tests and titrated skin prick test to monitor effect.\n\nAdverse events will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Allergic rhinitis to grass pollen, more than 3 mm reaction at skin prick test for grass, age between 18 and 40 years.\n\nExclusion Criteria:\n\n* Uncontrolled asthma.\n* Severe asthma with post bronchodilator test forced expiratory volume at 1 second less than 70% of expected.\n* Severe co morbidity. Allergy to Fenol or Aluminium hydroxid.\n* Any autoimmune diseases. Treatment with beta blocking medicine.\n* Any heart diseases.\n* Severe arterial hypertension. Kidney failure.\n* Known malignancy. Known pregnancy.'}, 'identificationModule': {'nctId': 'NCT02255604', 'briefTitle': 'Effect of Intralymphatic Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Effect of Intralymphatic Immunotherapy at Basophil Response and Plasmacell Kinetic in Patients With Allergic Rhinitis.', 'orgStudyIdInfo': {'id': 'ILIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intralymphatic immune therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.\n\nPatients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015.', 'interventionNames': ['Drug: Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3 intralymphatic immune therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.\n\nPatients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection.', 'interventionNames': ['Drug: alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.']}, {'type': 'SHAM_COMPARATOR', 'label': 'no intralymphatic immune therapy', 'description': 'Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline.\n\nPatients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control.', 'interventionNames': ['Drug: 0.1 ml Isoton saline']}], 'interventions': [{'name': 'Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.', 'type': 'DRUG', 'description': '4', 'armGroupLabels': ['intralymphatic immune therapy']}, {'name': 'alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.', 'type': 'DRUG', 'description': '3 injection into a lymphnode', 'armGroupLabels': ['3 intralymphatic immune therapy']}, {'name': '0.1 ml Isoton saline', 'type': 'DRUG', 'description': '4 injection into a lymphnode', 'armGroupLabels': ['no intralymphatic immune therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Lungemedicinsk Forskningsafdeling. Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Søren Helbo SH Skaarup, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lungemedicinsk forskningsafdeling. Aarhus University Hospital.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}