Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-04 @ 12:55 PM
Study NCT ID:
NCT03188120
Status:
COMPLETED
Last Update Posted:
2019-11-27
First Post:
2017-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Specific Use-Result of Spiriva Respimat® in Asthmatics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069447', 'term': 'Tiotropium Bromide'}], 'ancestors': [{'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Patients were not randomized and there are no within-study data. Patients in the study may differ from the overall asthma-treated population, or from treated patients who did not choose to participate in the study.'}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration until 30 days after last drug administration; up to 337 days', 'description': 'The safety set (The safety set includes all patients registered in the study and received the treatment) was used for adverse event reporting. A total of 193 patients were registered and Case Report Forms (CRFs) were collected from 193 patients. The safety set includes 180 patients, excluding 13 patients who had no visit after the first visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Spiriva Respimat Group', 'description': 'Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this noninterventional, observational study to collect new real world data (i.e., data under routine medical practice)', 'otherNumAtRisk': 180, 'deathsNumAtRisk': 180, 'otherNumAffected': 0, 'seriousNumAtRisk': 180, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Suspected Adverse Drug Reactions (ADRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiriva Respimat Group', 'description': 'Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this non-interventional, observational study to collect new real world data (i.e., data under routine medical practice)'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first drug administration until 30 days after last drug administration; up to 337 days', 'description': 'Number of participants with suspected adverse drug reactions (ADRs) is presented.\n\nAn Adverse Event (AE) was considered to be ADR if either the physician who reported the AE or the sponsor assessed its causal relationship as related.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set'}, {'type': 'SECONDARY', 'title': 'The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiriva Respimat Group', 'description': 'Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this non-interventional, observational study to collect new real world data (i.e., data under routine medical practice)'}], 'classes': [{'title': 'BL- WC W12-WC', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'BL-WC W12-IC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL-WC W12-PC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL-WC W12-UNK', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL-WC W12-MIS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL-IC W12-WC', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'BL-IC W12-IC', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'BL-IC W12-PC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL-IC W12-UNK', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL-IC W12-MIS', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'BL-PC W12-WC', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'BL-PC W12-IC', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'BL-PC W12-PC', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'BL-PC W12-UNK', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL-PC W12-MIS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL-UNK W12-WC', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'BL-UNK W12-IC', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'BL-UNK W12-PC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL-UNK W12-UNK', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'BL-UNK W12-MIS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'BL-MIS W12-WC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL-MIS W12-IC', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'BL-MIS W12-PC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL-MIS W12-UNK', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL-MIS W12-MIS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and 12 weeks', 'description': 'The change from baseline in asthma control status at week 12 using Asthma prevention and management guideline is presented.\n\nWell controlled is a better outcome compared to Insufficiently controlled and Poorly controlled outcomes.\n\nAbbreviations used:\n\nBaseline (BL), Week 12 (W12), Well-controlled (WC), Insufficiently controlled (IC), Poorly controlled (PC), Unknown (UNK), Missing (MIS); If a patient was well-controlled at baseline and maintained the state until Week 12, the effectiveness was assessed as "no change". If a patient insufficiently controlled or poorly controlled at baseline became well-controlled at Week 12, or if a patient was poorly controlled at baseline and became insufficiently controlled at Week 12, Spiriva Respimat was assessed as "effective" (or the patient assessed as a responder). If the disease condition did not improve in a patient at Week 12 from baseline, Spiriva Respimat was assessed as "ineffective" (or the patient assessed as a non-responder).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness set that excluded patients who were not associated with effectiveness data available (pulmonary function test or laboratory values related to asthma control status) as defined at baseline and/or on treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Spiriva Respimat Group', 'description': 'Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this non-interventional, observational study to collect new real world data (i.e., data under routine medical practice)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Case Report Form collected (treated)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Insufficient Effectiveness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Improved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'No visit after the first visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}], 'recruitmentDetails': 'This was a non-interventional, observational study to collect new real world data (i.e., data under routine medical practice) on safety and effectiveness of Spiriva Respimat treatment in patients.', 'preAssignmentDetails': 'All participants were screened for eligibility to participate in trial. They attended specialist sites to ensure that they (the participants) met all implemented inclusion/exclusion criteria. Participants were not to be entered to trial if any of the specific entry criteria was violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Spiriva Respimat Group', 'description': 'Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this non-interventional, observational study to collect new real world data (i.e., data under routine medical practice)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59.4', 'spread': '16.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '112', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Patients in safety set included patients ≥ 15 years old diagnosed with mild to moderate persistent bronchial asthma who are naive to Spiriva Respimat and received Spiriva Respimat for the first time for treatment of bronchial asthma on top of at least inhaled corticosteroid (ICS) treatment'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-16', 'size': 473220, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-11-08T08:11', 'hasProtocol': True}, {'date': '2018-10-19', 'size': 237432, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-11-08T08:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 193}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-08', 'studyFirstSubmitDate': '2017-06-13', 'resultsFirstSubmitDate': '2019-11-08', 'studyFirstSubmitQcDate': '2017-06-14', 'lastUpdatePostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-08', 'studyFirstPostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Suspected Adverse Drug Reactions (ADRs)', 'timeFrame': 'From first drug administration until 30 days after last drug administration; up to 337 days', 'description': 'Number of participants with suspected adverse drug reactions (ADRs) is presented.\n\nAn Adverse Event (AE) was considered to be ADR if either the physician who reported the AE or the sponsor assessed its causal relationship as related.'}], 'secondaryOutcomes': [{'measure': 'The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline', 'timeFrame': 'baseline and 12 weeks', 'description': 'The change from baseline in asthma control status at week 12 using Asthma prevention and management guideline is presented.\n\nWell controlled is a better outcome compared to Insufficiently controlled and Poorly controlled outcomes.\n\nAbbreviations used:\n\nBaseline (BL), Week 12 (W12), Well-controlled (WC), Insufficiently controlled (IC), Poorly controlled (PC), Unknown (UNK), Missing (MIS); If a patient was well-controlled at baseline and maintained the state until Week 12, the effectiveness was assessed as "no change". If a patient insufficiently controlled or poorly controlled at baseline became well-controlled at Week 12, or if a patient was poorly controlled at baseline and became insufficiently controlled at Week 12, Spiriva Respimat was assessed as "effective" (or the patient assessed as a responder). If the disease condition did not improve in a patient at Week 12 from baseline, Spiriva Respimat was assessed as "ineffective" (or the patient assessed as a non-responder).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The study objective is to investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use', 'detailedDescription': 'The study is Post-Marketing Surveillance on the Long-Term Use of Spiriva Respimat in Japanese patients with mild to moderate persistent asthma. The patient population who receive Spiriva Respimat and the safety profile is not expected to change. This study can investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with mild to moderate persistent bronchial asthma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with mild to moderate persistent bronchial asthma\n* Patient aged ≥ 15 years\n* Patients who are naive to Spiriva Respimat and receive Spiriva Respimat for the first time for treatment of bronchial asthma on top of at least ICS treatment.\n\nExclusion Criteria:\n\n* Patients who have a contraindication to Spiriva Respimat defined in the package insert for Spiriva Respimat\n* Patients who have been enrolled in this study before.'}, 'identificationModule': {'nctId': 'NCT03188120', 'briefTitle': 'Specific Use-Result of Spiriva Respimat® in Asthmatics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Specific Use-Result Surveillance of Spiriva Respimat in Asthmatics (Patients With Mild and Moderate Persistent Asthma)', 'orgStudyIdInfo': {'id': '0205-0536'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spiriva Respimat group', 'interventionNames': ['Drug: Spiriva Respimat']}], 'interventions': [{'name': 'Spiriva Respimat', 'type': 'DRUG', 'otherNames': ['FORVENT, SPIRIVA, SRIVASSO'], 'description': 'Drug', 'armGroupLabels': ['Spiriva Respimat group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1416017', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Nippon Boehringer Ingelheim Co., Ltd', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Yukako Ogi', 'role': 'STUDY_CHAIR', 'affiliation': 'zzCDMJP_PV_PMS@boehringer-ingelheim.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}