Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-28 @ 8:47 PM
Study NCT ID:
NCT01489020
Status:
COMPLETED
Last Update Posted:
2019-05-06
First Post:
2011-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maricruz.gomez@roxall.es', 'phone': '+34 944438000', 'title': 'Dr. M Cruz Gómez project manager of Roxall Medicina España S.A.', 'organization': 'Roxall Medicina España S.A.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Sample size'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group A Active', 'description': '6 administrations and 5 weeks duration\n\n1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals\n2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Group B Active', 'description': '8 administrations and 7 weeks duration\n\n1. Vial 1: 0.2 ml at 1 week intervals\n2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals\n3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Group C Active', 'description': '8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.\n\n1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval\n2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval\n3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval\n4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 8, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Group A Placebo', 'description': '6 administrations and 5 weeks duration\n\n1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals\n2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.\n\nsubcutaneous depot placebo', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Group B Placebo', 'description': '8 administrations and 7 weeks duration\n\n1. Vial 1: 0.2 ml at 1 week intervals\n2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals\n3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals\n\nsubcutaneous depot placebo', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Group C Placebo', 'description': '8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.\n\n1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval\n2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval\n3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval\n4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval\n\nsubcutaneous depot placebo', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'cephalea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'alterations injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 16, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 20, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Otitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4}, {'groupId': 'EG004', 'numAtRisk': 4}, {'groupId': 'EG005', 'numAtRisk': 4}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'pyrosis', '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}, {'groupId': 'EG003', 'numAtRisk': 4}, {'groupId': 'EG004', 'numAtRisk': 4}, {'groupId': 'EG005', 'numAtRisk': 4}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Facial edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4}, {'groupId': 'EG004', 'numAtRisk': 4}, {'groupId': 'EG005', 'numAtRisk': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4}, {'groupId': 'EG004', 'numAtRisk': 4}, {'groupId': 'EG005', 'numAtRisk': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Edema in upper extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4}, {'groupId': 'EG004', 'numAtRisk': 4}, {'groupId': 'EG005', 'numAtRisk': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'broncoconstriction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4}, {'groupId': 'EG004', 'numAtRisk': 4}, {'groupId': 'EG005', 'numAtRisk': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4}, {'groupId': 'EG004', 'numAtRisk': 4}, {'groupId': 'EG005', 'numAtRisk': 4}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'allergic rhinoconjunctivitis', '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}, {'groupId': 'EG003', 'numAtRisk': 4}, {'groupId': 'EG004', 'numAtRisk': 4}, {'groupId': 'EG005', 'numAtRisk': 4}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number and Seriousness of Both Local and Systemic Adverse Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A Active', 'description': '6 administrations and 5 weeks duration\n\n1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals\n2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo'}, {'id': 'OG001', 'title': 'Group B Active', 'description': '8 administrations and 7 weeks duration\n\n1. Vial 1: 0.2 ml at 1 week intervals\n2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals\n3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo'}, {'id': 'OG002', 'title': 'Group C Active', 'description': '8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.\n\n1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval\n2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval\n3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval\n4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo'}, {'id': 'OG003', 'title': 'Group A Placebo', 'description': '6 administrations and 5 weeks duration\n\n1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals\n2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.\n\nsubcutaneous depot placebo'}, {'id': 'OG004', 'title': 'Group B Placebo', 'description': '8 administrations and 7 weeks duration\n\n1. Vial 1: 0.2 ml at 1 week intervals\n2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals\n3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals\n\nsubcutaneous depot placebo'}, {'id': 'OG005', 'title': 'Group C Placebo', 'description': '8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.\n\n1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval\n2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval\n3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval\n4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval\n\nsubcutaneous depot placebo'}], 'classes': [{'title': 'Local adverse reactions number', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Systemic adverse reactions number', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )', 'description': 'The primary end points were the number of ARs and the severity of local and systemic ARs (SARs) to SCIT administration. Proportions were compared between study arms. The tolerability of SCIT was evaluated by early and late local reactions (i.e., local swelling and redness) and systemic reactions after each injection (any symptoms from organs distant from the location of the injection). Reactions were classified depending on the severity and onset of the reaction, according to the EAACI classification (Alvarez-Cuesta 2006).', 'unitOfMeasure': 'adverse reactions number', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immunoglobulin Levels (IgE Specific) Active Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A Active', 'description': '6 administrations and 5 weeks duration\n\n1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals\n2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'OG001', 'title': 'Group A Placebo', 'description': '6 administrations and 5 weeks duration\n\n1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals\n2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'OG002', 'title': 'Group B Active', 'description': '8 administrations and 7 weeks duration\n\n1. Vial 1: 0.2 ml at 1 week intervals\n2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals\n3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'OG003', 'title': 'Group B Placebo', 'description': '8 administrations and 7 weeks duration\n\n1. Vial 1: 0.2 ml at 1 week intervals\n2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals\n3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'OG004', 'title': 'Group C Active', 'description': '8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.\n\n1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval\n2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval\n3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval\n4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'OG005', 'title': 'Group C Placebo', 'description': '8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.\n\n1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval\n2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval\n3. Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval\n4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0750', 'spread': '0.393', 'groupId': 'OG000'}, {'value': '-0.0055', 'spread': '0.013', 'groupId': 'OG001'}, {'value': '0.1709', 'spread': '0.274', 'groupId': 'OG002'}, {'value': '-0.1445', 'spread': '0.639', 'groupId': 'OG003'}, {'value': '-0.0398', 'spread': '0.507', 'groupId': 'OG004'}, {'value': '0.0395', 'spread': '0.039', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)', 'description': 'Changes on immunoglobulin level determinations (specific IgE, IgG and IgG4) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immunoglobulin Levels (IgG Total) Active Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A Active', 'description': '6 administrations and 5 weeks duration\n\n1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals\n2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'OG001', 'title': 'Group A Placebo', 'description': '6 administrations and 5 weeks duration\n\n1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals\n2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'OG002', 'title': 'Group B Active', 'description': '8 administrations and 7 weeks duration\n\n1. Vial 1: 0.2 ml at 1 week intervals\n2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals\n3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'OG003', 'title': 'Group B Placebo', 'description': '8 administrations and 7 weeks duration\n\n1. Vial 1: 0.2 ml at 1 week intervals\n2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals\n3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'OG004', 'title': 'Group C Active', 'description': '8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.\n\n1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval\n2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval\n3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval\n4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'OG005', 'title': 'Group C Placebo', 'description': '8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.\n\n1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval\n2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval\n3. Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval\n4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8813', 'spread': '0.484', 'groupId': 'OG000'}, {'value': '-0.0405', 'spread': '0.097', 'groupId': 'OG001'}, {'value': '-0.9589', 'spread': '0.536', 'groupId': 'OG002'}, {'value': '-0.0953', 'spread': '0.137', 'groupId': 'OG003'}, {'value': '-0.4918', 'spread': '0.389', 'groupId': 'OG004'}, {'value': '-0.0425', 'spread': '0.090', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)', 'description': 'Changes on immunoglobulin level determinations (IgG) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immunoglobulin Levels (IgG 4) Active Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A Active', 'description': '6 administrations and 5 weeks duration\n\n1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals\n2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'OG001', 'title': 'Group A Placebo', 'description': '6 administrations and 5 weeks duration\n\n1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals\n2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'OG002', 'title': 'Group B Active', 'description': '8 administrations and 7 weeks duration\n\n1. Vial 1: 0.2 ml at 1 week intervals\n2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals\n3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'OG003', 'title': 'Group B Placebo', 'description': '8 administrations and 7 weeks duration\n\n1. Vial 1: 0.2 ml at 1 week intervals\n2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals\n3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'OG004', 'title': 'Group C Active', 'description': '8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.\n\n1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval\n2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval\n3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval\n4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'OG005', 'title': 'Group C Placebo', 'description': '8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.\n\n1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval\n2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval\n3. Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval\n4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0878', 'spread': '0.770', 'groupId': 'OG000'}, {'value': '0.0838', 'spread': '0.518', 'groupId': 'OG001'}, {'value': '-1.2885', 'spread': '0.844', 'groupId': 'OG002'}, {'value': '0.0770', 'spread': '0.162', 'groupId': 'OG003'}, {'value': '-0.8243', 'spread': '0.663', 'groupId': 'OG004'}, {'value': '0.0580', 'spread': '0.039', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)', 'description': 'Changes on immunoglobulin level determinations (IgG4) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A Active', 'description': '6 administrations and 5 weeks duration\n\n1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals\n2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'FG001', 'title': 'Group A Placebo', 'description': '6 administrations and 5 weeks duration\n\n1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals\n2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'FG002', 'title': 'Group B Active', 'description': '8 administrations and 7 weeks duration\n\n1. Vial 1: 0.2 ml at 1 week intervals\n2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals\n3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'FG003', 'title': 'Group B Placebo', 'description': '8 administrations and 7 weeks duration\n\n1. Vial 1: 0.2 ml at 1 week intervals\n2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals\n3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'FG004', 'title': 'Group C Active', 'description': '8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.\n\n1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval\n2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval\n3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval\n4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}, {'id': 'FG005', 'title': 'Group C Placebo', 'description': '8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.\n\n1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval\n2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval\n3. Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval\n4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Concomitant disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A Active', 'description': '6 administrations and 5 weeks duration\n\n1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals\n2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo'}, {'id': 'BG001', 'title': 'Group B Active', 'description': '8 administrations and 7 weeks duration\n\n1. Vial 1: 0.2 ml at 1 week intervals\n2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals\n3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo'}, {'id': 'BG002', 'title': 'Group C Active', 'description': '8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.\n\n1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval\n2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval\n3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval\n4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval\n\nsubcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo'}, {'id': 'BG003', 'title': 'Group A Placebo', 'description': '6 administrations and 5 weeks duration\n\n1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals\n2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.\n\nSubcutaneous depot placebo'}, {'id': 'BG004', 'title': 'Group B Placebo', 'description': '8 administrations and 7 weeks duration\n\n1. Vial 1: 0.2 ml at 1 week intervals\n2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals\n3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals\n\nsubcutaneous depot placebo'}, {'id': 'BG005', 'title': 'Group C Placebo', 'description': '8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.\n\n1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval\n2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval\n3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval\n4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval\n\nsubcutaneous depot placebo'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.66', 'spread': '8.93', 'groupId': 'BG000'}, {'value': '30.88', 'spread': '9.77', 'groupId': 'BG001'}, {'value': '31.80', 'spread': '8.85', 'groupId': 'BG002'}, {'value': '33.93', 'spread': '9.49', 'groupId': 'BG003'}, {'value': '33.93', 'spread': '9.49', 'groupId': 'BG004'}, {'value': '33.93', 'spread': '9.49', 'groupId': 'BG005'}, {'value': '32.68', 'spread': '9.34', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-29', 'studyFirstSubmitDate': '2011-12-02', 'resultsFirstSubmitDate': '2018-08-10', 'studyFirstSubmitQcDate': '2011-12-07', 'lastUpdatePostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-29', 'studyFirstPostDateStruct': {'date': '2011-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and Seriousness of Both Local and Systemic Adverse Reactions', 'timeFrame': 'From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )', 'description': 'The primary end points were the number of ARs and the severity of local and systemic ARs (SARs) to SCIT administration. Proportions were compared between study arms. The tolerability of SCIT was evaluated by early and late local reactions (i.e., local swelling and redness) and systemic reactions after each injection (any symptoms from organs distant from the location of the injection). Reactions were classified depending on the severity and onset of the reaction, according to the EAACI classification (Alvarez-Cuesta 2006).'}], 'secondaryOutcomes': [{'measure': 'Immunoglobulin Levels (IgE Specific) Active Versus Placebo', 'timeFrame': 'Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)', 'description': 'Changes on immunoglobulin level determinations (specific IgE, IgG and IgG4) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.'}, {'measure': 'Immunoglobulin Levels (IgG Total) Active Versus Placebo', 'timeFrame': 'Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)', 'description': 'Changes on immunoglobulin level determinations (IgG) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.'}, {'measure': 'Immunoglobulin Levels (IgG 4) Active Versus Placebo', 'timeFrame': 'Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)', 'description': 'Changes on immunoglobulin level determinations (IgG4) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Allergy', 'Immunotherapy', 'Allergic Rhinoconjunctivitis', 'D. pteronyssinus', 'house dust allergy'], 'conditions': ['Allergic Rhinoconjunctivitis']}, 'descriptionModule': {'briefSummary': 'Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study was to assess safety and tolerability of 3 different subcutaneous immunotherapy dose escalations in patients allergic to Dermatophagoides pteronyssinus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with allergic rhinoconjunctivitis with or without asthma against DPT during a minimum of 1 year prior to study participation.\n2. Patients must sign the informed consent form.\n3. Patients must be between 18 and 60 years of age.\n4. Patients who obtained a prick test result greater or equal to 3 mm diameter and a specific IgE greater or equal to class 2 (CAP/PHADIA) to DPT.\n5. Patients will preferably be monosensitized to DPT. In the case of polysensitized patients they can only be included if other sensitizations are caused by seasonal allergens whose pollination do not overlap with the study period.\n6. Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0\n7. Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active\n\nExclusion Criteria:\n\n1. Stable and continued use of medication for allergic pathology during 2 weeks prior to inclusion.\n2. Patients sensitised to other perennial allergens clinically relevant and with specific IgE levels greater or equal to class 2 CAP/PHADIA.\n3. Patients who received immunotherapy in the previous 5 years for DPT or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.\n4. Patients with severe asthma or FEV1 minor than 70% or asthma requiring inhaled or systemic corticoid treatment at the time of study entry or within 8 weeks prior to treatment initiation.\n5. Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study.\n6. Patients with a previous history of anaphylaxis\n7. Patients with chronic urticaria\n8. Patients with unstable angina\n9. Patients with uncontrolled hypertension\n10. Patients with clinically significant arrythmias\n11. Patients with neoplasia\n12. Patients with clinically relevant malformations of the upper respiratory tract.\n13. Other chronic or immunological disease that could interfere with the assessment of the investigational product or that could generate any additional risk for the patients\n14. Patients who have participated in another clinical trial within 3 month prior to enrolment.\n15. Patients under treatment with tricyclic antidepressives, psychotropics beta-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)\n16. Female patients who are pregnant or breast-feeding or women of childbearing potential that do not agree to use an appropriate contraception method during the study if they are sexually active, if they have not been surgically sterilised or present any other incapacity to bear\n17. Patient who does not attend the visits\n18. Patient's lack of collaboration or refusal to participate"}, 'identificationModule': {'nctId': 'NCT01489020', 'briefTitle': 'Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Roxall Medicina España S.A'}, 'officialTitle': 'Multicentre Phase I Randomized Double Blind Placebo Controlled Study of Subcutaneous Immunotherapy in Subjects With Allergic Rhinoconjunctivitis ± Asthma Sensitised to Dermatophagoides Pteronyssinus.', 'orgStudyIdInfo': {'id': 'BIA-DPT-P1-001'}, 'secondaryIdInfos': [{'id': '2009-016277-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A active', 'description': '6 administrations and 5 weeks duration\n\n1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals\n2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.', 'interventionNames': ['Biological: subcutaneous immunotherapy with DPT extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group A placebo', 'description': '6 administrations and 5 weeks duration\n\n1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals\n2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.', 'interventionNames': ['Biological: Subcutaneous depot placebo']}, {'type': 'EXPERIMENTAL', 'label': 'group B active', 'description': '8 administrations and 7 weeks duration\n\n1. Vial 1: 0.2 ml at 1 week intervals\n2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals\n3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals', 'interventionNames': ['Biological: subcutaneous immunotherapy with DPT extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B placebo', 'description': '8 administrations and 7 weeks duration\n\n1. Vial 1: 0.2 ml at 1 week intervals\n2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals\n3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals', 'interventionNames': ['Biological: Subcutaneous depot placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group C active', 'description': '8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.\n\n1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval\n2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval\n3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval\n4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval', 'interventionNames': ['Biological: subcutaneous immunotherapy with DPT extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group C placebo', 'description': '8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.\n\n1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval\n2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval\n3. Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval\n4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval', 'interventionNames': ['Biological: Subcutaneous depot placebo']}], 'interventions': [{'name': 'subcutaneous immunotherapy with DPT extract', 'type': 'BIOLOGICAL', 'otherNames': ['DPT depot vaccine'], 'description': 'Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)', 'armGroupLabels': ['Group A active', 'Group C active', 'group B active']}, {'name': 'Subcutaneous depot placebo', 'type': 'BIOLOGICAL', 'description': 'Increasing doses of subcutaneous depot placebo in three different scales', 'armGroupLabels': ['Group A placebo', 'Group B placebo', 'Group C placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48013', 'city': 'Bilbao', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de Basurto', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Mª Dolores Hernández, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario La Fe'}, {'name': 'Ignacio Antépara, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Basurto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roxall Medicina España S.A', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}