Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 8:06 AM
Study NCT ID:
NCT00434434
Status:
COMPLETED
Last Update Posted:
2022-12-14
First Post:
2007-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], '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': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069444', 'term': 'Omalizumab'}], 'ancestors': [{'id': 'D000888', 'term': 'Antibodies, Anti-Idiotypic'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Genentech, Inc.'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety evaluable population', 'eventGroups': [{'id': 'EG000', 'title': 'Liquid Omalizumab', 'description': 'Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening', 'otherNumAtRisk': 23, 'otherNumAffected': 7, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lyopholized Omalizumab', 'description': 'Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening', 'otherNumAtRisk': 24, 'otherNumAffected': 6, 'seriousNumAtRisk': 24, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening', 'otherNumAtRisk': 14, 'otherNumAffected': 5, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Facial Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Joint Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Joint Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Sinus Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Middle Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Periorbital Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'seriousEvents': [{'term': 'Abortion Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liquid Omalizumab', 'description': 'Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening'}, {'id': 'OG001', 'title': 'Lyopholized Omalizumab', 'description': 'Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening'}], 'classes': [{'categories': [{'measurements': [{'value': '1.15', 'groupId': 'OG000', 'lowerLimit': '-2.30', 'upperLimit': '4.03'}, {'value': '1.85', 'groupId': 'OG001', 'lowerLimit': '-1.10', 'upperLimit': '3.50'}, {'value': '0.36', 'groupId': 'OG002', 'lowerLimit': '-1.09', 'upperLimit': '3.09'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'exact Wilcoxon-Mann-Whitney'}, {'pValue': '0.0133', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'exact Wilcoxon-Mann-Whitney'}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline to Week 16', 'description': 'The primary analysis included two tests: a test for superiority of the lyophilized formulation of omalizumab compared with placebo in the change of allergen concentration and a test for the superiority of the aged liquid omalizumab compared with placebo. The difference for the change in the allergen concentration between the lyophilized formulation of omalizumab and placebo, and between the aged liquid omalizumab and placebo were assessed by the exact Wilcoxon-Mann-Whitney test.', 'unitOfMeasure': 'concentration change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Ratio of the Allergen Forced Expiratory Volume at One Second (FEV1) Two-point Slope at the Week 16 Allergen Challenge to the Allergen FEV1 Two-point Slope at the Baseline Allergen Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liquid Omalizumab', 'description': 'Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening'}, {'id': 'OG001', 'title': 'Lyopholized Omalizumab', 'description': 'Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000', 'lowerLimit': '-0.09', 'upperLimit': '3.18'}, {'value': '0.29', 'groupId': 'OG001', 'lowerLimit': '-0.26', 'upperLimit': '2.08'}, {'value': '0.95', 'groupId': 'OG002', 'lowerLimit': '0.12', 'upperLimit': '2.20'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'exact Wilcoxon-Mann-Whitney'}, {'pValue': '0.0028', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'exact Wilcoxon-Mann-Whitney'}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline to Week 16', 'description': 'FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity, measured in liters. The allergen FEV1 two-point slope is defined as the final percent change in FEV1 from pre-challenge value divided by the final value of allergen concentration used in the challenge.', 'unitOfMeasure': 'ratio of FEV1', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liquid Omalizumab', 'description': 'Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening'}, {'id': 'FG001', 'title': 'Lyopholized Omalizumab', 'description': 'Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Liquid Omalizumab', 'description': 'Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening'}, {'id': 'BG001', 'title': 'Lyopholized Omalizumab', 'description': 'Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 40 years', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}, {'title': '41 to 65 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': '> 65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.5', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '30.6', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '32.0', 'spread': '9.6', 'groupId': 'BG002'}, {'value': '30.1', 'spread': '11.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-09', 'studyFirstSubmitDate': '2007-02-11', 'resultsFirstSubmitDate': '2010-02-17', 'studyFirstSubmitQcDate': '2007-02-11', 'lastUpdatePostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-04-30', 'studyFirstPostDateStruct': {'date': '2007-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)', 'timeFrame': 'From baseline to Week 16', 'description': 'The primary analysis included two tests: a test for superiority of the lyophilized formulation of omalizumab compared with placebo in the change of allergen concentration and a test for the superiority of the aged liquid omalizumab compared with placebo. The difference for the change in the allergen concentration between the lyophilized formulation of omalizumab and placebo, and between the aged liquid omalizumab and placebo were assessed by the exact Wilcoxon-Mann-Whitney test.'}], 'secondaryOutcomes': [{'measure': 'Ratio of the Allergen Forced Expiratory Volume at One Second (FEV1) Two-point Slope at the Week 16 Allergen Challenge to the Allergen FEV1 Two-point Slope at the Baseline Allergen Challenge', 'timeFrame': 'From baseline to Week 16', 'description': 'FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity, measured in liters. The allergen FEV1 two-point slope is defined as the final percent change in FEV1 from pre-challenge value divided by the final value of allergen concentration used in the challenge.'}]}, 'conditionsModule': {'keywords': ['AQUA', 'anti-CD11', 'CD11a', 'Asthma', 'Allergy'], 'conditions': ['Allergic Asthma']}, 'descriptionModule': {'briefSummary': 'This was a multicenter, randomized, double-blind, parallel-group, three-arm, placebo-controlled study designed to demonstrate the efficacy of two different formulations of omalizumab compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult subjects with mild allergic asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Informed Consent Form\n* Meet criteria for the diagnosis of allergic asthma\n* Be between the ages of 18 to 65 years\n* Have a normal chest X-ray within 2 years of screening\n\nExclusion Criteria:\n\n* Need daily controller medication for asthma\n* History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin)\n* Have a documented medical history of anaphylaxis\n* Have lung disease other than mild allergic asthma\n* Have taken other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer\n* Are unable or unwilling to comply with study procedures and visits\n* Are pregnant or lactating\n* Have significant medical illness other than asthma, including malignancies, parasitic infections, immune system disorders, and thrombocytopenia\n* Have been treated with omalizumab within 12 months prior to screening\n* Currently smoke or have a history of smoking more than 10 pack-years\n* Have a history of drug or alcohol abuse, which, in the judgment of the investigator, may put the subject at risk for being unable to participate fully in the study for the duration of the study'}, 'identificationModule': {'nctId': 'NCT00434434', 'acronym': 'AQUA', 'briefTitle': 'A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lyophilized and Aged Liquid Omalizumab in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma', 'orgStudyIdInfo': {'id': 'Q4160g'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: omalizumab']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: omalizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'omalizumab', 'type': 'DRUG', 'description': 'Aged Liquid; subcutaneous repeating dose', 'armGroupLabels': ['1']}, {'name': 'omalizumab', 'type': 'DRUG', 'description': 'Lyophilized; subcutaneous repeating dose', 'armGroupLabels': ['2']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Subcutaneous repeating dose', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dennis Wong, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}