Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-02-26 @ 7:47 PM
Study NCT ID:
NCT03394508
Status:
COMPLETED
Last Update Posted:
2020-09-28
First Post:
2017-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Safety and Efficacy of Intralymphatic Immunotherapy in Pollen Allergic Adolescents and Young Adults With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], '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': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000075462', 'term': 'Serum Albumin, Human'}], 'ancestors': [{'id': 'D012709', 'term': 'Serum Albumin'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jon.konradsen@ki.se', 'phone': '+46704242058', 'title': 'Jon Konradsen', 'organization': 'Karolinska Institutet'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'a=active,p=placebo:No booster dose and no follow-up (1a), No NPTs before (1a) and at follow up (1a, 1p), No methacholine, quality of life in the second follow-up (1a). No symptoms and medication scores (3a, 3p), No spirometry at follow-up (1a,1p).'}}, 'adverseEventsModule': {'timeFrame': 'Within 24 hours after each injection, up to 24 months for patients receiving active treatment and up to 12 months for patients receiving placebo.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': "ALK diluent 0,3% human albumin'\n\nALK diluent 0.1 ml human albumin: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval", 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 5, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active Treatment', 'description': 'Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension\n\nALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection before the second pollen season.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 13, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itchyness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swollen locally around injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tiredness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eczema', 'notes': 'The patient reported worsened eczema after the first treatment period and declined the booster dose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Generalized urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sarcoidosis', 'notes': 'One patient was diagnosed with Sarcoidosis 3 months after the booster injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Symptoms Score After Nasal Allergen Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "ALK diluent 0,3% human albumin'\n\nALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval"}, {'id': 'OG001', 'title': 'Active Treatment', 'description': 'Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension\n\nALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.'}], 'classes': [{'title': 'After the first pollen season', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG000', 'lowerLimit': '-9', 'upperLimit': '5'}, {'value': '-4', 'groupId': 'OG001', 'lowerLimit': '-12', 'upperLimit': '4'}]}]}, {'title': 'After the second season compared to pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG001', 'lowerLimit': '-7', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': '0,1 ml of ALK Aquagen birch or timothy 10 000 SQU/ml is deposited in each nostril and allergy symptoms are recorded. Symptoms during NPTs were scored according to the Lebel scoring scale. Symtom scores at 5, 15, and 30 minutes after nasal administration of the allergenextract were summed to represent the symptom-score at each nasal challenge (at inclusion, 12 months after inclusion and for the active patients 24 months after inclusion). The scoring system identifies nasal, eye, and ear symptoms: rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus, watery eyes, and itchy ears, each graded on a scale from 0 to 3 points, and a total score was summarized after subtracting the starting score (min score is 0 and maximum score is 54 + the number of sneezes). Higher scores mean worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were injected 3 times before the start of the first pollen season. The study was unblinded at a follow-up visit after the end of the first season. Active patients returned for a booster injection (1000 SQ-U) before the second season and performed a new follow-up. Eleven patients (6 active, 5 placebo) did not have full analysis data sets.'}, {'type': 'SECONDARY', 'title': 'Change on Visual Analogue Scale (VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "ALK diluent 0,3% human albumin'\n\nALK diluent 0,1 ml human albumin: Intralymphatic injection. 3 injections with 4-5 weeks interval."}, {'id': 'OG001', 'title': 'Active Treatment', 'description': 'Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension.\n\nALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.'}], 'classes': [{'title': 'After first season', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8.5'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9.1'}]}]}, {'title': 'After second season compared to pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': 'Treatment effect was evaluated by asking the patients to compare their allergic symptoms during the last pollen season with the pollen season before treatment on a visual analogue scale ranging from 0 (unchanged symptoms, no improvement) to 10 (total symptom relief, complete recovery).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "ALK diluent 0,3% human albumin'\n\nALK diluent 0,1 ml human albumin: Intralymphatic injection. 3 injections with 4-5 weeks interval"}, {'id': 'OG001', 'title': 'Active Treatment', 'description': 'Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension.\n\nALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.'}], 'classes': [{'title': 'After first season', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '2.1'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '1.1'}]}]}, {'title': 'After second season compared to pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': 'Difference before and after treatment in Quality of Life. Quality of life was assessed using the Juniper Asthma Quality of Life Questionnaire, giving a score ranging from 1 to 7, and a change in score of 0.5 points is considered clinically relevant. Lower value is considered worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.'}, {'type': 'SECONDARY', 'title': 'Change in Allergen-specific Serum Immunoglobulin E (IgE) Levels Compared to Before Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "ALK diluent 0,3% human albumin'\n\nALK diluent 0.1 ml human albumin: Intralymphatic injection. 3 injections with 4-5 weeks interval"}, {'id': 'OG001', 'title': 'Active Treatment', 'description': 'Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension.\n\nALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.'}], 'classes': [{'title': 'IgE after first season', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-370', 'upperLimit': '70'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '-50', 'upperLimit': '116'}]}]}, {'title': 'IgE after second season compared to pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001', 'lowerLimit': '-111', 'upperLimit': '83'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': "Allergen-specific IgE levels were measured by ImmunoCAP (Thermo Scientific, Uppsala, Sweden) for birch (t3) and timothy grass (g6) pollen according to the manufacturer's instructions. A cutoff level ≥ 0.35 kUA/L was considered positive.", 'unitOfMeasure': 'units on a scale IgE:Kua/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.'}, {'type': 'SECONDARY', 'title': 'Change in Asthma Symptom Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "ALK diluent 0,3% human albumin'\n\nALK diluent 0.1 ml human albumin: Intralymphatic injection. 3 injections with 4-5 weeks interval"}, {'id': 'OG001', 'title': 'Active Treatment', 'description': 'Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension.\n\nALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.'}], 'classes': [{'title': 'After the first pollen seasonllen season', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '4'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '3'}]}]}, {'title': 'After second season compared to pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '-10', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': 'Asthma control 4 weeks before follow-up was estimated with the asthma control test. The score is based on a questionnaire with 5 questions concerning the patients asthma. Each question can be given a score from 1 to 5 points. The answers for each question is added together, where a minimum score of 5 and a maximum score of 25 can be obtained. Higher scores indicate improved outcome and a score of 19 or less suggests poorly controlled asthma.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.'}, {'type': 'SECONDARY', 'title': 'Change in Pulmonary Function Measurement (Spirometry)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "ALK diluent 0,3% human albumin'\n\nALK diluent 0.1 ml human albumin: Intralymphatic injection. 3 injections with 4-5 weeks interval"}, {'id': 'OG001', 'title': 'Active Treatment', 'description': 'Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension.\n\nALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.'}], 'classes': [{'title': 'After first season', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'groupId': 'OG000', 'lowerLimit': '-27', 'upperLimit': '4'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-15', 'upperLimit': '14'}]}]}, {'title': 'After second season compared to pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.5', 'groupId': 'OG001', 'lowerLimit': '-32', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': 'FEV1 were measured according to international guidelines and results presented in % of predicted values according to the patients height, gender, age and weight.', 'unitOfMeasure': 'percent predicted FEV1', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.'}, {'type': 'SECONDARY', 'title': 'Changes in Airway Inflammation Assessed by Exhaled Nitric Oxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "ALK diluent 0,3% human albumin'\n\nALK diluent 0.1 ml human albumin: Intralymphatic injection. 3 injections with 4-5 weeks interval"}, {'id': 'OG001', 'title': 'Active Treatment', 'description': 'Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension.\n\nALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.'}], 'classes': [{'title': 'After first season', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG000', 'lowerLimit': '-52', 'upperLimit': '19'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-27', 'upperLimit': '13'}]}]}, {'title': 'After second season compared to pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG001', 'lowerLimit': '-28', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': 'Nitric oxide in exhaled air, p.p.b. were measured according to international guidelines, and higher values indicate worse outcome.', 'unitOfMeasure': 'parts per billion (ppb)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.'}, {'type': 'SECONDARY', 'title': 'Change in Symptom and Medication-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "ALK diluent 0,3% human albumin'\n\nALK diluent 0.1 ml human albumin: Intralymphatic injection. 3 injections with 4-5 weeks interval"}, {'id': 'OG001', 'title': 'Active Treatment', 'description': 'Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension.\n\nALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.'}], 'classes': [{'title': 'Symptom score after first season', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '0'}, {'value': '-4', 'groupId': 'OG001', 'lowerLimit': '-13', 'upperLimit': '2'}]}]}, {'title': 'Medication score after first season', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '3'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-11', 'upperLimit': '2'}]}]}, {'title': 'Symptom score after second season', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG001', 'lowerLimit': '-15', 'upperLimit': '0'}]}]}, {'title': 'Medication score after second season', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3', 'groupId': 'OG001', 'lowerLimit': '-12', 'upperLimit': '-1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': 'Modified Symptom scores and Medication score were calculated taking into account the frequency: daily (4 points); every second day (3 points); 1 to 3 days per week (2 points); occasionally (1 point); never (0 points), for the following symptoms: blocked nose, rhinorrhea, fatigue, sneezing, and asthma symptoms, and for the following medications used: local and systemic antihistamines, nasal steroids, asthma medication, and eye drops. A minimum score of 0 and a maximum score of 20 points for symptoms and 16 points for medication could be obtained. Higher values indicate worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.'}, {'type': 'SECONDARY', 'title': 'Changes in Response to a Bronchial Challenge With Methacholine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "ALK diluent 0,3% human albumin'\n\nALK diluent 0.1 ml human albumin: Intralymphatic injection. 3 injections with 4-5 weeks interval"}, {'id': 'OG001', 'title': 'Active Treatment', 'description': 'Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension.\n\nALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.'}], 'classes': [{'title': 'After the first pollen season', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG000', 'lowerLimit': '-150', 'upperLimit': '203'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '-131', 'upperLimit': '278'}]}]}, {'title': 'After the second pollen season compared to pre-tre', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG001', 'lowerLimit': '-34', 'upperLimit': '489'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': 'Methacholine challenge to test the bronchial hyperresponsiveness in the airways of the included subjects. The subject will inhale increasing doses of methacholine. Spirometry is performed before and between each inhalation. The cumulative dose of methacholine needed to elicit at 20% decrease in FEV1 (PD20) is reported. Lower values indicate worse outcome.', 'unitOfMeasure': 'units on a scale PD20', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.'}, {'type': 'SECONDARY', 'title': 'Change in Allergen-specific Serum Immunoglobulin (Ig) G and Ig4 Levels Compared to Before Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': "ALK diluent 0,3% human albumin'\n\nALK diluent 0.1 ml human albumin: Intralymphatic injection. 3 injections with 4-5 weeks interval"}, {'id': 'OG001', 'title': 'Active Treatment', 'description': 'Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension.\n\nALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and an additional booster injection with 1000 units before the second pollen season.'}], 'classes': [{'title': 'IgG after first season', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.25', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '1'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '2.9'}]}]}, {'title': 'IgG4 after first season', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '-0.76', 'upperLimit': '0.08'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '-0.73', 'upperLimit': '2'}]}]}, {'title': 'IgG after second season compared to pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-2.5', 'upperLimit': '4'}]}]}, {'title': 'IgG4 after second season compared to pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.69'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': "Allergen-specific IgG and IgG4 level was measured by ImmunoCAP (Thermo Scientific, Uppsala, Sweden) for birch (t3) and timothy grass (g6) pollen according to the manufacturer's instructions. A cutoff 2 mg/L for IgG and 0.05 mg/L for IgG4 was considered positive.", 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '4 left the study before analysis of results; 3 active were excluded after the first treatment period because of deviations from the treatment protocol, and 1 placebo left the study after the first treatment period, before the follow-up. 11 patients (6 active, 5 placebo) did not have full analysis data sets, see limitations section for details.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': "ALK diluent 0,3% human albumin'\n\nALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval"}, {'id': 'FG001', 'title': 'Active Treatment', 'description': 'Intervention: Drug ALK Alutard birch or 5-grasses. Grass pollen suspension or birch pollen suspension\n\nALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and a booster injection with 1000 units before the second pollen season'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': "ALK diluent 0,3% human albumin'\n\nALK diluent 0,3% human albumin: Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval"}, {'id': 'BG001', 'title': 'Active Treatment', 'description': 'Intervention: Drug ALK Alutard birch or 5-grasses Grass pollen suspension or birch pollen suspension.\n\nALK Alutard birch or 5-grasses: Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval and a booster injection with 1000 units before the second pollen season.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000', 'lowerLimit': '16', 'upperLimit': '36'}, {'value': '19.5', 'groupId': 'BG001', 'lowerLimit': '16', 'upperLimit': '42'}, {'value': '19', 'groupId': 'BG002', 'lowerLimit': '16', 'upperLimit': '42'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000', 'lowerLimit': '16', 'upperLimit': '36'}, {'value': '19.5', 'groupId': 'BG001', 'lowerLimit': '16', 'upperLimit': '42'}, {'value': '19', 'groupId': 'BG002', 'lowerLimit': '16', 'upperLimit': '42'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Four patients were removed or left the study before analysis of results; 3 patients (active group) were excluded after the first treatment period because of deviations from the treatment protocol, and 1 patient (placebo) left the study after the first treatment period, before the follow-up.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-24', 'size': 107263, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-20T08:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-25', 'studyFirstSubmitDate': '2017-12-06', 'resultsFirstSubmitDate': '2020-03-11', 'studyFirstSubmitQcDate': '2018-01-08', 'lastUpdatePostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-25', 'studyFirstPostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Symptoms Score After Nasal Allergen Challenge', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': '0,1 ml of ALK Aquagen birch or timothy 10 000 SQU/ml is deposited in each nostril and allergy symptoms are recorded. Symptoms during NPTs were scored according to the Lebel scoring scale. Symtom scores at 5, 15, and 30 minutes after nasal administration of the allergenextract were summed to represent the symptom-score at each nasal challenge (at inclusion, 12 months after inclusion and for the active patients 24 months after inclusion). The scoring system identifies nasal, eye, and ear symptoms: rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus, watery eyes, and itchy ears, each graded on a scale from 0 to 3 points, and a total score was summarized after subtracting the starting score (min score is 0 and maximum score is 54 + the number of sneezes). Higher scores mean worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Change on Visual Analogue Scale (VAS', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': 'Treatment effect was evaluated by asking the patients to compare their allergic symptoms during the last pollen season with the pollen season before treatment on a visual analogue scale ranging from 0 (unchanged symptoms, no improvement) to 10 (total symptom relief, complete recovery).'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': 'Difference before and after treatment in Quality of Life. Quality of life was assessed using the Juniper Asthma Quality of Life Questionnaire, giving a score ranging from 1 to 7, and a change in score of 0.5 points is considered clinically relevant. Lower value is considered worse outcome.'}, {'measure': 'Change in Allergen-specific Serum Immunoglobulin E (IgE) Levels Compared to Before Treatment', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': "Allergen-specific IgE levels were measured by ImmunoCAP (Thermo Scientific, Uppsala, Sweden) for birch (t3) and timothy grass (g6) pollen according to the manufacturer's instructions. A cutoff level ≥ 0.35 kUA/L was considered positive."}, {'measure': 'Change in Asthma Symptom Scores', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': 'Asthma control 4 weeks before follow-up was estimated with the asthma control test. The score is based on a questionnaire with 5 questions concerning the patients asthma. Each question can be given a score from 1 to 5 points. The answers for each question is added together, where a minimum score of 5 and a maximum score of 25 can be obtained. Higher scores indicate improved outcome and a score of 19 or less suggests poorly controlled asthma.'}, {'measure': 'Change in Pulmonary Function Measurement (Spirometry)', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': 'FEV1 were measured according to international guidelines and results presented in % of predicted values according to the patients height, gender, age and weight.'}, {'measure': 'Changes in Airway Inflammation Assessed by Exhaled Nitric Oxide', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': 'Nitric oxide in exhaled air, p.p.b. were measured according to international guidelines, and higher values indicate worse outcome.'}, {'measure': 'Change in Symptom and Medication-score', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': 'Modified Symptom scores and Medication score were calculated taking into account the frequency: daily (4 points); every second day (3 points); 1 to 3 days per week (2 points); occasionally (1 point); never (0 points), for the following symptoms: blocked nose, rhinorrhea, fatigue, sneezing, and asthma symptoms, and for the following medications used: local and systemic antihistamines, nasal steroids, asthma medication, and eye drops. A minimum score of 0 and a maximum score of 20 points for symptoms and 16 points for medication could be obtained. Higher values indicate worse outcome.'}, {'measure': 'Changes in Response to a Bronchial Challenge With Methacholine', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': 'Methacholine challenge to test the bronchial hyperresponsiveness in the airways of the included subjects. The subject will inhale increasing doses of methacholine. Spirometry is performed before and between each inhalation. The cumulative dose of methacholine needed to elicit at 20% decrease in FEV1 (PD20) is reported. Lower values indicate worse outcome.'}, {'measure': 'Change in Allergen-specific Serum Immunoglobulin (Ig) G and Ig4 Levels Compared to Before Treatment', 'timeFrame': 'At inclusion (pre-treatment), 12 months after inclusion (after first pollen season) and for the active treated patients 24 months after inclusion (after the second pollen season).', 'description': "Allergen-specific IgG and IgG4 level was measured by ImmunoCAP (Thermo Scientific, Uppsala, Sweden) for birch (t3) and timothy grass (g6) pollen according to the manufacturer's instructions. A cutoff 2 mg/L for IgG and 0.05 mg/L for IgG4 was considered positive."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rhinitis', 'Asthma', 'Allergy']}, 'referencesModule': {'references': [{'pmid': '26706294', 'type': 'BACKGROUND', 'citation': 'Patterson AM, Bonny AE, Shiels WE 2nd, Erwin EA. Three-injection intralymphatic immunotherapy in adolescents and young adults with grass pollen rhinoconjunctivitis. Ann Allergy Asthma Immunol. 2016 Feb;116(2):168-70. doi: 10.1016/j.anai.2015.11.010. Epub 2015 Dec 17. No abstract available.'}, {'pmid': '24035151', 'type': 'BACKGROUND', 'citation': 'Witten M, Malling HJ, Blom L, Poulsen BC, Poulsen LK. Is intralymphatic immunotherapy ready for clinical use in patients with grass pollen allergy? J Allergy Clin Immunol. 2013 Nov;132(5):1248-1252.e5. doi: 10.1016/j.jaci.2013.07.033. Epub 2013 Sep 13. No abstract available.'}, {'pmid': '23374268', 'type': 'BACKGROUND', 'citation': 'Hylander T, Latif L, Petersson-Westin U, Cardell LO. Intralymphatic allergen-specific immunotherapy: an effective and safe alternative treatment route for pollen-induced allergic rhinitis. J Allergy Clin Immunol. 2013 Feb;131(2):412-20. doi: 10.1016/j.jaci.2012.10.056.'}, {'pmid': '22464647', 'type': 'BACKGROUND', 'citation': 'Senti G, Crameri R, Kuster D, Johansen P, Martinez-Gomez JM, Graf N, Steiner M, Hothorn LA, Gronlund H, Tivig C, Zaleska A, Soyer O, van Hage M, Akdis CA, Akdis M, Rose H, Kundig TM. Intralymphatic immunotherapy for cat allergy induces tolerance after only 3 injections. J Allergy Clin Immunol. 2012 May;129(5):1290-6. doi: 10.1016/j.jaci.2012.02.026. Epub 2012 Mar 30.'}, {'pmid': '26817454', 'type': 'RESULT', 'citation': 'Hylander T, Larsson O, Petersson-Westin U, Eriksson M, Kumlien Georen S, Winqvist O, Cardell LO. Intralymphatic immunotherapy of pollen-induced rhinoconjunctivitis: a double-blind placebo-controlled trial. Respir Res. 2016 Jan 27;17:10. doi: 10.1186/s12931-016-0324-9.'}]}, 'descriptionModule': {'briefSummary': 'The study evaluates the safety and efficacy of intralymphatic allergen-specific immunotherapy given to adolescents and young adults who are allergic to grass or birch pollen and have mild or moderate asthma. Patients will be treated with three intralymphatic injections; 1000 SQ-U x3 with 4-5 weeks interval, or placebo with 4-5 weeks interval. The patients receiving treatment will be given a fourth injection one year after the initial injections. The study is conducted in collaboration between Professor Lars Olof Cardell (ENT), prof Gunilla Hedlin (Pediatrics) and prof Marianne van Hage (Immunology)".', 'detailedDescription': '30 patients with seasonal allergic rhinitis due to birch or grass pollen are included. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses / birch or placebo. The patients receiving treatment will be given a fourth injection one year after the initial injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Allergic rhinitis due to grass or birch pollen\n* Mild to moderate asthma with a positive methacholine challenge\n* Accepted and signed informed consent.\n\nExclusion Criteria:\n\n* Previously subcutaneous immunotherapy (SCIT) with total symptom relief.\n* Previously SCIT but no symptom improvement at all.\n* Sensitizations to house dust mite or furry animals, with ongoing exposure and symptoms.\n* Severe atopic dermatitis.\n* Patients with significant diseases other than allergic rhinitis. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.\n* Patients with a respiratory tract infection in the past 4 weeks prior to Visit 2.\n* Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants).\n* Known autoimmune or collagen disease\n* Cardiovascular disease\n* Hepatic disease\n* Known renal insufficiency\n* Cancer\n* Hematologic disease\n* Chronic infectious disease\n* Any medication with a possible side-effect of interfering with the immune response\n* Previous immuno- or chemotherapy\n* Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers)\n* Major metabolic disease\n* Known or suspected allergy to the study product\n* Obesity with BMI \\> 30 since subcutaneous fat makes ultrasound imaging of lymph nodes harder which may risk the correct placement of injection.\n* Patients who, in the opinion of the investigator, abuse alcohol or drugs within 2 years prior to Visit 1.\n* Patients who have taken an investigational drug within 1 month or six half lives, whichever is greater, prior to Visit 1.\n* Mental incapability of coping with the study\n* Withdrawal of informed consent"}, 'identificationModule': {'nctId': 'NCT03394508', 'briefTitle': 'The Safety and Efficacy of Intralymphatic Immunotherapy in Pollen Allergic Adolescents and Young Adults With Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'The Safety and Efficacy of Intralymphatic Immunotherapy in Pollen Allergic Adolescents and Young Adults With Asthma: A Randomized Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'DNR 2012/701 EPN Lund'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': "ALK diluent 0,3% human albumin'", 'interventionNames': ['Drug: ALK diluent 0,3% human albumin']}, {'type': 'EXPERIMENTAL', 'label': 'Active treatment', 'description': 'Intervention: Drug ALK Alutard birch or 5-grasses. Grass pollen suspension or birch pollen suspension', 'interventionNames': ['Drug: ALK Alutard birch or 5-grasses']}], 'interventions': [{'name': 'ALK Alutard birch or 5-grasses', 'type': 'DRUG', 'otherNames': ['ALK Alutard birch pollen or ALK Alutard grass pollen'], 'description': 'Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval (0,1 ml) and one additional booster injection with 1000 units before the second pollen season.', 'armGroupLabels': ['Active treatment']}, {'name': 'ALK diluent 0,3% human albumin', 'type': 'DRUG', 'otherNames': ['Human albumin'], 'description': 'Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gunilla Hedlin', 'investigatorAffiliation': 'Karolinska Institutet'}}}}