Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT01380327
Status:
COMPLETED
Last Update Posted:
2014-06-11
First Post:
2011-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Biomarkers of Cockroach Sublingual Immunotherapy 2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DAITClinicalTrialsGov@niaid.nih.gov', 'phone': '301-594-7669', 'title': 'Associate Director, Clinical Research Operations Program', 'organization': 'DAIT/NIAID'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Participant enrollment to end of study (up to 3 months post-baseline)', 'description': "This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)", 'eventGroups': [{'id': 'EG000', 'title': 'Cockroach Sublingual Immunotherapy (SLIT) - High Dose', 'description': 'Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume \\[w/v\\]) twice-daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.', 'otherNumAtRisk': 34, 'otherNumAffected': 20, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cockroach Sublingual Immunotherapy (SLIT) - Low Dose', 'description': 'Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume \\[w/v\\]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.', 'otherNumAtRisk': 33, 'otherNumAffected': 25, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily or twice-daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume \\[w/v\\]) was achieved.', 'otherNumAtRisk': 32, 'otherNumAffected': 21, 'seriousNumAtRisk': 32, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Ear pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oral pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tongue pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Renal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in German Cockroach-Specific Serum IgE Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cockroach Sublingual Immunotherapy (SLIT) - High Dose', 'description': 'Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \\[w/v\\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.'}, {'id': 'OG001', 'title': 'Cockroach Sublingual Immunotherapy (SLIT) - Low Dose', 'description': 'Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \\[w/v\\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received daily (placebo-low dose) or twice-daily (placebo - high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume \\[w/v\\]) was achieved.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.5'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '3.3'}, {'value': '1.2', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.5'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '1.2', 'ciUpperLimit': '2.3', 'estimateComment': 'Estimated value \\& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.18) vs. high dose group (numerator=1.98).', 'groupDescription': 'Analysis compared cockroach SLIT -high dose, Placebo - high dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '1.7', 'ciUpperLimit': '3.1', 'estimateComment': 'Estimated value \\& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.18) vs. low dose group (numerator=2.69).', 'groupDescription': 'Analysis compared cockroach SLIT - low dose, placebo - low dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline through 3 months of treatment', 'description': 'Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with complete data.'}, {'type': 'SECONDARY', 'title': 'Change in German Cockroach-Specific Serum IgG Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cockroach Sublingual Immunotherapy (SLIT) - High Dose', 'description': 'Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \\[w/v\\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.'}, {'id': 'OG001', 'title': 'Cockroach Sublingual Immunotherapy (SLIT) - Low Dose', 'description': 'Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \\[w/v\\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received daily (placebo-low dose) or twice-daily (placebo - high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume \\[w/v\\]) was achieved.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '1.4'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.2'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '1.1', 'ciUpperLimit': '1.4', 'estimateComment': 'Estimated value \\& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.04) vs. high dose group (numerator=1.32).', 'groupDescription': 'Analysis compared cockroach SLIT - high dose, placebo - high dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.11', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '1.0', 'ciUpperLimit': '1.2', 'estimateComment': 'Estimated value \\& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.04) vs. low dose group (numerator=1.14).', 'groupDescription': 'Analysis compared cockroach SLIT - low dose, placebo - low dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline through 3 months of treatment', 'description': 'Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum immunoglobulin G (IgG). This result is an indicator of immune modulation over time, however its clinical significance is unclear.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with complete data.'}, {'type': 'SECONDARY', 'title': 'Change in German Cockroach-Specific Serum IgG4 Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cockroach Sublingual Immunotherapy (SLIT) - High Dose', 'description': 'Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \\[w/v\\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.'}, {'id': 'OG001', 'title': 'Cockroach Sublingual Immunotherapy (SLIT) - Low Dose', 'description': 'Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \\[w/v\\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received daily (placebo-low dose) or twice-daily (placebo - high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume \\[w/v\\]) was achieved.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '2.1'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.9'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '1.4'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '1.0', 'ciUpperLimit': '2.4', 'estimateComment': 'Estimated value and associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.03) vs. high dose group (numerator=1.57).', 'groupDescription': 'Analysis compared cockroach SLIT - high dose, placebo - high dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.13', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '0.9', 'ciUpperLimit': '2.2', 'estimateComment': 'Estimated value \\& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.03) vs. low dose group (numerator=1.45).', 'groupDescription': 'Analysis compared cockroach SLIT - low dose, placebo - low dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline through 3 months of treatment', 'description': 'Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum immunoglobulin subclass 4 (IgG4). This result is an indicator of immune modulation over time, however its clinical significance is unclear.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with complete data.'}, {'type': 'SECONDARY', 'title': 'Change in IgE Fragment Antibody Binding (FAB) Activity Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cockroach Sublingual Immunotherapy (SLIT) - High Dose', 'description': 'Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \\[w/v\\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.'}, {'id': 'OG001', 'title': 'Cockroach Sublingual Immunotherapy (SLIT) - Low Dose', 'description': 'Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \\[w/v\\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received daily (placebo-low dose) or twice-daily (placebo - high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume \\[w/v\\]) was achieved.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.2', 'groupId': 'OG000', 'lowerLimit': '-20.8', 'upperLimit': '6.5'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '33.2'}, {'value': '5.7', 'groupId': 'OG002', 'lowerLimit': '-9.5', 'upperLimit': '20.9'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment effect', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.9', 'ciLowerLimit': '-33.2', 'ciUpperLimit': '7.5', 'estimateComment': 'Estimated value\\& associated CI is the treatment effect: baseline to post-baseline change in measurement in high dose group (-7.2) minus baseline to post-baseline change in measurement in placebo group (5.7) .', 'groupDescription': 'Analysis compared cockroach SLIT - high dose, placebo - high dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.20', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Treatment effect', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.5', 'ciLowerLimit': '-7.1', 'ciUpperLimit': '34.1', 'estimateComment': 'Estimated value\\& associated CI is the treatment effect: baseline to post-baseline change in measurement in high dose group (19.2) minus baseline to post-baseline change in measurement in placebo group (5.7) .', 'groupDescription': 'Analysis compared cockroach SLIT - low dose, placebo - low dose', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 3 months of treatment', 'description': 'Outcome is change in mean IgE FAB activity level from baseline to post-baseline (status post 3 months of treatment). Serum from cockroach sublingual immunotherapy (SLIT)-treated participants were analyzed to determine if treatment inhibits in-vitro cockroach SLIT, using the per protocol allergenic extract doses. This result is an indicator of immune modulation over time, however its clinical significance is unclear.(Reference: Shamji MH et al. The IgE-facilitated allergen binding (FAB) assay: validation of a novel flow-cytometric based method for the detection of inhibitory antibody responses. J Immunol Methods 2006;317(1-2): 71-9).', 'unitOfMeasure': 'Percent antibody binding', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with complete data.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With the Occurrence of Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cockroach Sublingual Immunotherapy (SLIT) - High Dose', 'description': 'Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \\[w/v\\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.'}, {'id': 'OG001', 'title': 'Cockroach Sublingual Immunotherapy (SLIT) - Low Dose', 'description': 'Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \\[w/v\\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received daily (placebo-low dose) or twice-daily (placebo - high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume \\[w/v\\]) was achieved.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participant enrollment to end of study (up to 3 months post-baseline)', 'description': 'Percent of participants who experienced at least one AE.', 'unitOfMeasure': 'Percentage of population', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cockroach Sublingual Immunotherapy (SLIT) - High Dose', 'description': 'Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \\[w/v\\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.'}, {'id': 'FG001', 'title': 'Cockroach Sublingual Immunotherapy (SLIT) - Low Dose', 'description': 'Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \\[w/v\\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received daily (placebo-low dose) or twice-daily (placebo - high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume \\[w/v\\]) was achieved.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number in intent-to-treat having reached maximum tolerated dose with =/\\> 1 one post-baseline measure', 'groupId': 'FG000', 'numSubjects': '30'}, {'comment': 'Number in intent-to-treat having reached maximum tolerated dose with =/\\> 1 one post-baseline measure', 'groupId': 'FG001', 'numSubjects': '31'}, {'comment': 'Number in intent-to-treat having reached maximum tolerated dose with =/\\> 1 one post-baseline measure', 'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Housing situation precluded ability to k', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Questionable onset of epilepsy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Five NIAID ICAC sites in the United States recruited the targeted number of study participants who fulfilled entry criteria between May 2011 and February 2012. Of the ninety-nine subjects enrolled in the study, eighty-nine achieved the milestone of randomization and are included in the Participant Flow: Overall Study Results Section.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cockroach Sublingual Immunotherapy (SLIT) - High Dose', 'description': 'Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \\[w/v\\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.'}, {'id': 'BG001', 'title': 'Cockroach Sublingual Immunotherapy (SLIT) - Low Dose', 'description': 'Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \\[w/v\\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received daily (placebo-low dose) or twice-daily (placebo - high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume \\[w/v\\]) was achieved.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '3.6', 'groupId': 'BG000'}, {'value': '11.0', 'spread': '3.3', 'groupId': 'BG001'}, {'value': '10.8', 'spread': '3.7', 'groupId': 'BG002'}, {'value': '10.7', 'spread': '3.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'German Cockroach-Specific Serum Immunoglobulin E (IgE) Levels', 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'BG000', 'lowerLimit': '0.4', 'upperLimit': '349.0'}, {'value': '4.9', 'groupId': 'BG001', 'lowerLimit': '0.4', 'upperLimit': '174.0'}, {'value': '9.2', 'groupId': 'BG002', 'lowerLimit': '0.4', 'upperLimit': '98.6'}, {'value': '6.4', 'groupId': 'BG003', 'lowerLimit': '0.4', 'upperLimit': '349.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kU/L', 'dispersionType': 'FULL_RANGE'}, {'title': 'German Cockroach-Specific Serum Immunoglobulin G (IgG) Levels', 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'BG000', 'lowerLimit': '2.0', 'upperLimit': '33.8'}, {'value': '4.3', 'groupId': 'BG001', 'lowerLimit': '2.0', 'upperLimit': '20.6'}, {'value': '5.1', 'groupId': 'BG002', 'lowerLimit': '2.0', 'upperLimit': '24.9'}, {'value': '4.5', 'groupId': 'BG003', 'lowerLimit': '2.0', 'upperLimit': '33.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'FULL_RANGE'}, {'title': 'German Cockroach-Specific Serum Immunoglobulin Subclass 4 (IgG4) Levels', 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'BG000', 'lowerLimit': '0.0', 'upperLimit': '7.5'}, {'value': '0.1', 'groupId': 'BG001', 'lowerLimit': '0.0', 'upperLimit': '3.5'}, {'value': '0.5', 'groupId': 'BG002', 'lowerLimit': '0.0', 'upperLimit': '2.6'}, {'value': '0.2', 'groupId': 'BG003', 'lowerLimit': '0.0', 'upperLimit': '7.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'FULL_RANGE'}, {'title': 'German Cockroach-Specific IgE Fragment Antibody Binding (FAB) Activity', 'classes': [{'categories': [{'measurements': [{'value': '84.9', 'groupId': 'BG000', 'lowerLimit': '5.0', 'upperLimit': '426.4'}, {'value': '78.3', 'groupId': 'BG001', 'lowerLimit': '6.2', 'upperLimit': '421.7'}, {'value': '80.8', 'groupId': 'BG002', 'lowerLimit': '16.9', 'upperLimit': '201.5'}, {'value': '81.5', 'groupId': 'BG003', 'lowerLimit': '5.0', 'upperLimit': '426.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Percent antibody binding', 'dispersionType': 'FULL_RANGE'}, {'title': 'German Cockroach Prick Skin Test Wheal Size', 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'BG000', 'lowerLimit': '3.0', 'upperLimit': '12.0'}, {'value': '5.0', 'groupId': 'BG001', 'lowerLimit': '3.5', 'upperLimit': '12.0'}, {'value': '5.8', 'groupId': 'BG002', 'lowerLimit': '4.0', 'upperLimit': '11.5'}, {'value': '5.3', 'groupId': 'BG003', 'lowerLimit': '3.0', 'upperLimit': '12.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mm', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-05', 'studyFirstSubmitDate': '2011-06-22', 'resultsFirstSubmitDate': '2014-05-02', 'studyFirstSubmitQcDate': '2011-06-22', 'lastUpdatePostDateStruct': {'date': '2014-06-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-02', 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in German Cockroach-Specific Serum IgE Over Time', 'timeFrame': 'Baseline through 3 months of treatment', 'description': 'Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.'}], 'secondaryOutcomes': [{'measure': 'Change in German Cockroach-Specific Serum IgG Over Time', 'timeFrame': 'Baseline through 3 months of treatment', 'description': 'Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum immunoglobulin G (IgG). This result is an indicator of immune modulation over time, however its clinical significance is unclear.'}, {'measure': 'Change in German Cockroach-Specific Serum IgG4 Over Time', 'timeFrame': 'Baseline through 3 months of treatment', 'description': 'Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum immunoglobulin subclass 4 (IgG4). This result is an indicator of immune modulation over time, however its clinical significance is unclear.'}, {'measure': 'Change in IgE Fragment Antibody Binding (FAB) Activity Over Time', 'timeFrame': 'Baseline through 3 months of treatment', 'description': 'Outcome is change in mean IgE FAB activity level from baseline to post-baseline (status post 3 months of treatment). Serum from cockroach sublingual immunotherapy (SLIT)-treated participants were analyzed to determine if treatment inhibits in-vitro cockroach SLIT, using the per protocol allergenic extract doses. This result is an indicator of immune modulation over time, however its clinical significance is unclear.(Reference: Shamji MH et al. The IgE-facilitated allergen binding (FAB) assay: validation of a novel flow-cytometric based method for the detection of inhibitory antibody responses. J Immunol Methods 2006;317(1-2): 71-9).'}, {'measure': 'Percent of Participants With the Occurrence of Adverse Events (AEs)', 'timeFrame': 'Participant enrollment to end of study (up to 3 months post-baseline)', 'description': 'Percent of participants who experienced at least one AE.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cockroach', 'immunotherapy', 'sublingual immunotherapy (SLIT)', 'inner city asthma'], 'conditions': ['Asthma', 'Perennial Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '24184147', 'type': 'RESULT', 'citation': "Wood RA, Togias A, Wildfire J, Visness CM, Matsui EC, Gruchalla R, Hershey G, Liu AH, O'Connor GT, Pongracic JA, Zoratti E, Little F, Granada M, Kennedy S, Durham SR, Shamji MH, Busse WW. Development of cockroach immunotherapy by the Inner-City Asthma Consortium. J Allergy Clin Immunol. 2014 Mar;133(3):846-52.e6. doi: 10.1016/j.jaci.2013.08.047. Epub 2013 Nov 1."}], 'seeAlsoLinks': [{'url': 'http://www.niaid.nih.gov', 'label': 'National Institute of Allergy and Infectious Diseases (NIAID)'}]}, 'descriptionModule': {'briefSummary': 'This trial is a follow-up study of the ICAC-12 Phase I/II trial (NCT00829985), and is designed to study biomarkers of the immune response to allergen immunotherapy and the safety of this therapy in a pediatric population.', 'detailedDescription': 'Over the past two decades, scientific evidence has shown that the combination of cockroach allergy and cockroach exposure is one of the most important factors contributing to the dramatic increase in asthma morbidity seen in inner city children with asthma. Therefore, a major goal of the National Institute of Allergy and Infectious Diseases (NIAID) Inner City Asthma Consortium (ICAC) is ultimately to conduct a large multi-center trial of cockroach sublingual immunotherapy (SLIT) in inner-city asthma. As a step toward achieving this goal, ICAC is conducting a clinical trial comparing two doses of glycerinated German cockroach (Blattella germanica) allergenic extract to placebo, administered under the tongue (sublingual).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a history of perennial allergic rhinitis, asthma, or both, before study entry. For those with asthma:\n\n 1. a diagnosis of asthma will be defined as a report by the participant that they have had a clinical diagnosis of asthma made by a physician over a year ago\n 2. the participant's asthma must be well controlled as defined by: ii. a forced expiratory volume at one second (FEV1) greater than or equal to 80% predicted value with or without controller medication ii. albuterol use for no more than 3 days per week in each of the previous 2 weeks for asthma symptoms (not including exercise prophylaxis)\n* Are sensitive to German cockroach (Blattella germanica) as documented by a positive (\\>/=3 mm greater than negative control) skin prick test result and detectable German cockroach specific IgE (\\>/=0.35 kUA/L)\n* Have no known contraindications to therapy with glycerinated German cockroach allergenic extract or placebo\n* Parent or legally authorized representative (LAR) of child is willing to sign the written Informed Consent prior to initiation of any study procedure\n\nExclusion Criteria:\n\n* Are pregnant or lactating. Females must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception)\n* Cannot perform spirometry or peak flow at screening\n* Have an asthma severity classification at recruitment of severe persistent, using the National Asthma Education and Prevention Program (NAEPP) classification, as evidenced by at least one of the following:\n\n 1. requires a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid\n 2. have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months\n 3. have been treated with depot steroids within the last 12 months\n 4. have been hospitalized for asthma within the 6 months prior to recruitment\n 5. have had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to recruitment\n* Do not have access to a phone (needed for scheduling appointments)\n* Have received allergen immunotherapy in the last 12 months prior to recruitment or who plan to initiate or resume allergen immunotherapy during the study\n* Have previously been treated with anti-IgE therapy within 1 year of recruitment\n* Have received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study\n* Have in the last 3 months prior to recruitment experienced on average \\>/=1 day per week any of the symptoms below:\n\n 1. nausea or vomiting\n 2. abdominal pain or cramps severe enough to interfere with daily activities (excluding those associated with menstruation).\n 3. diarrhea\n* Refuse to sign the Epinephrine Auto-injector Training Form\n\nParticipants who meet any of the following criteria are not eligible for enrollment and may not be reassessed. Participants are ineligible if they:\n\n* Do not primarily speak English\n* Plan to move from the area during the study period\n* Have a history of idiopathic anaphylaxis or anaphylaxis grade 2 or higher\n* Have unstable angina, significant arrhythmia, uncontrolled hypertension, history of autoimmune disease, or other chronic or immunological diseases that in the opinion of the investigator might interfere with the evaluation of the investigational agent or pose additional risk to the patient (e.g., gastrointestinal disease, gastroesophageal reflux disease, chronic infections, scleroderma, hepatic, and gallbladder disease)\n* Are using tricyclic antidepressants or beta-adrenergic blocker drugs (either oral and/or topical route\\[s\\] of administration)"}, 'identificationModule': {'nctId': 'NCT01380327', 'acronym': 'BioCSI-2', 'briefTitle': 'Biomarkers of Cockroach Sublingual Immunotherapy 2', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Biomarker-Based Pilot Study of Cockroach Sublingual Immunotherapy in Cockroach Sensitive Children With Asthma and/or Perennial Allergic Rhinitis', 'orgStudyIdInfo': {'id': 'DAIT ICAC-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cockroach Sublingual Immunotherapy (SLIT) - Low Dose', 'description': 'Glycerinated German cockroach (Blatella germanica) allergen extract administered sublingually with a maximally tolerated dose of 420 microliters daily', 'interventionNames': ['Biological: Cockroach Sublingual Immunotherapy (SLIT) - Low Dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered sublingually not to exceed the maximally tolerated dose of either 1.) 420 microliters daily (placebo - low dose randomization) or 2.) 840 microliters twice daily (placebo - high dose randomization)', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cockroach Sublingual Immunotherapy (SLIT) - High Dose', 'description': 'Glycerinated German cockroach (Blatella germanica) allergen extract administered sublingually with a maximally tolerated dose of 840 microliters taken twice daily', 'interventionNames': ['Biological: Cockroach Sublingual Immunotherapy (SLIT) - High Dose']}], 'interventions': [{'name': 'Cockroach Sublingual Immunotherapy (SLIT) - Low Dose', 'type': 'BIOLOGICAL', 'otherNames': ['Blattella germanica'], 'description': 'Participants are randomized to receive daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \\[w/v\\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.', 'armGroupLabels': ['Cockroach Sublingual Immunotherapy (SLIT) - Low Dose']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['German cockroach (Blattella germanica) placebo'], 'description': 'Participants are randomized to receive either daily (low dose) or twice-daily (high dose) placebo treatment placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume \\[w/v\\]) was achieved.', 'armGroupLabels': ['Placebo']}, {'name': 'Cockroach Sublingual Immunotherapy (SLIT) - High Dose', 'type': 'BIOLOGICAL', 'otherNames': ['Blattella germanica'], 'description': 'Participants are randomized to receive twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume \\[w/v\\] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.', 'armGroupLabels': ['Cockroach Sublingual Immunotherapy (SLIT) - High Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Children's Memorial Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Robert Wood, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}