Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT00789360
Status:
COMPLETED
Last Update Posted:
2019-03-11
First Post:
2008-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Staccato Loxapine Pulmonary Safety in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsInfo@alexza.com', 'phone': '650.944.7071', 'title': 'Executive VP, Research & Development, Regulatory & Quality', 'organization': 'Alexza Pharmaceuticals, Inc'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment', 'description': 'Adverse events (AEs) were assessed predose and at 16 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff', 'eventGroups': [{'id': 'EG000', 'title': 'Inhaled Placebo', 'description': 'Inhaled Staccato Placebo, 2 inhalations, 8 hours apart\n\nInhaled Placebo: Inhaled Staccato Placebo, 2 inhalations, 8 hours apart', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 5, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Inhaled Loxapine', 'description': 'Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart\n\nInhaled Loxapine: Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 16, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Loxapine', 'description': 'Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart'}, {'id': 'OG001', 'title': 'Inhaled Staccato Placebo', 'description': 'Inhaled Staccato Placebo, 2 inhalations, 8 hours apart'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1042', 'groupId': 'OG000', 'lowerLimit': '-0.1776', 'upperLimit': '-0.0310'}, {'value': '-0.1025', 'groupId': 'OG001', 'lowerLimit': '-0.18099', 'upperLimit': '-0.02393'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Maximum LS mean change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0917', 'ciLowerLimit': '-0.028', 'ciUpperLimit': '0.212', 'estimateComment': 'Maximum difference occurred at 10 hours', 'groupDescription': 'The largest treatment difference (Loxapine - Placebo) in change in FEV1 from baseline by spirometry', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '17 post-treatment time points (15 min to 32 hr)', 'description': 'The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FEV1 Change from Same-Period Baseline,', 'unitOfMeasure': 'liters', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Crossover Spirometry Population (all subjects receiving both inhaled loxapine and inhaled placebo)\n\nLSM and CI statistics were based on the individual (within subject) differences between loxapine and placebo exposures'}, {'type': 'SECONDARY', 'title': 'The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Loxapine', 'description': 'Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart'}, {'id': 'OG001', 'title': 'Inhaled Staccato', 'description': 'Inhaled Staccato Placebo, 2 inhalation, 8 hours apart'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.271', 'groupId': 'OG000', 'lowerLimit': '-0.370', 'upperLimit': '-0.172'}, {'value': '-0.149', 'groupId': 'OG001', 'lowerLimit': '-0.264', 'upperLimit': '-0.035'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Maximum LS mean change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.154', 'ciLowerLimit': '-0.290', 'ciUpperLimit': '-0.019', 'estimateComment': 'Greatest difference occurred at 9 hours after Dose 1', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '17 post-treatment time points (15 min to 32 hr)', 'description': 'The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FVC Change from Same-Period Baseline', 'unitOfMeasure': 'liters', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Crossover Spirometry Population (all subjects receiving both inhaled loxapine and inhaled placebo)\n\nLSM and CI statistics were based on the individual (within subject) differences between loxapine and placebo exposures'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inhaled Placebo / Loxapine', 'description': 'Inhaled Staccato Placebo, 2 inhalations, 8 hours apart followed by Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart'}, {'id': 'FG001', 'title': 'Inhaled Loxapine / Placebo', 'description': 'Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart followed by Inhaled Staccato Placebo, 2 inhalations, 8 hours apart'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Each investigator obtained approval from their IRB for their advertisements and other subject recruitment procedures', 'preAssignmentDetails': 'At screening and before administration of Dose 1 in each treatment period, the following were confirmed: forced expiratory volume in 1 second (FEV1) ≥85% of predicted, forced vital capacity (FVC) ≥85% of predicted, and oxygen saturation by pulse oximetry (SpO2)\n\n≥95% on room air.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Inhaled Placebo / Loxapine', 'description': 'Inhaled Staccato Placebo, 2 inhalations, 8 hours apart followed by Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart'}, {'id': 'BG001', 'title': 'Inhaled Loxapine / Placebo', 'description': 'Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart followed by Inhaled Staccato Placebo, 2 inhalations, 8 hours apart'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'spread': '13.65', 'groupId': 'BG000'}, {'value': '28.7', 'spread': '9.75', 'groupId': 'BG001'}, {'value': '30', 'spread': '11.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-18', 'studyFirstSubmitDate': '2008-11-07', 'resultsFirstSubmitDate': '2017-03-12', 'studyFirstSubmitQcDate': '2008-11-10', 'lastUpdatePostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-18', 'studyFirstPostDateStruct': {'date': '2008-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry', 'timeFrame': '17 post-treatment time points (15 min to 32 hr)', 'description': 'The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FEV1 Change from Same-Period Baseline,'}], 'secondaryOutcomes': [{'measure': 'The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry', 'timeFrame': '17 post-treatment time points (15 min to 32 hr)', 'description': 'The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FVC Change from Same-Period Baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.', 'detailedDescription': 'The planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* nonsmoker subjects in good general health with normal spirometry at screening AND baseline\n\nExclusion Criteria:\n\n* history of asthma, COPD, or any other acute or chronic pulmonary disease or bronchodilator use'}, 'identificationModule': {'nctId': 'NCT00789360', 'briefTitle': 'Staccato Loxapine Pulmonary Safety in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexza Pharmaceuticals, Inc.'}, 'officialTitle': 'Pulmonary Safety of Repeat Doses of Staccato® Loxapine for Inhalation in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'AMDC-004-104'}, 'secondaryIdInfos': [{'id': '12 September 2008'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inhaled Placebo crossed over to Inhaled Loxapine', 'description': 'Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; washout of at least 4 days; Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart', 'interventionNames': ['Drug: Inhaled Placebo', 'Drug: Inhaled Loxapine']}, {'type': 'EXPERIMENTAL', 'label': 'Inhaled Loxapine crossed over to Inhaled Placebo', 'description': 'Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart; washout of at least 4 days; Inhaled Staccato Placebo, 2 inhalations, 8 hours apart;', 'interventionNames': ['Drug: Inhaled Placebo', 'Drug: Inhaled Loxapine']}], 'interventions': [{'name': 'Inhaled Placebo', 'type': 'DRUG', 'description': 'Inhaled Staccato Placebo, 2 inhalations, 8 hours apart', 'armGroupLabels': ['Inhaled Loxapine crossed over to Inhaled Placebo', 'Inhaled Placebo crossed over to Inhaled Loxapine']}, {'name': 'Inhaled Loxapine', 'type': 'DRUG', 'description': 'Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart', 'armGroupLabels': ['Inhaled Loxapine crossed over to Inhaled Placebo', 'Inhaled Placebo crossed over to Inhaled Loxapine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02747', 'city': 'North Dartmouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Northeast Medical Research', 'geoPoint': {'lat': 41.63899, 'lon': -70.97032}}], 'overallOfficials': [{'name': 'David S. Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northeast Medical Research, North Dartmouth, MA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexza Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}