Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-02-02 @ 8:15 AM
Study NCT ID:
NCT00615992
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2008-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines
Sponsor:
Organization:
Raw JSON
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The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '4 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Spiriva® (Tiotropium Bromide)', 'description': 'Tiotropium bromide 18μg inhalation capsules once-daily', 'otherNumAtRisk': 754, 'otherNumAffected': 0, 'seriousNumAtRisk': 754, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva', 'denoms': [{'units': 'Participants', 'counts': [{'value': '687', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiriva® (Tiotropium Bromide)', 'description': 'Tiotropium bromide 18μg inhalation capsules once-daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)', 'description': 'The scores are final, not a difference in score. 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'description': 'Tiotropium bromide 18μg inhalation capsules once-daily'}], 'classes': [{'title': 'Very good', 'categories': [{'measurements': [{'value': '407', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Not satisfactory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)', 'description': 'Rating scale ranging from very good (best value) to not satisfactory (worst value)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.'}, {'type': 'SECONDARY', 'title': 'Global Assessment of Tolerability by Physician', 'denoms': [{'units': 'Participants', 'counts': [{'value': '647', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiriva® (Tiotropium Bromide)', 'description': 'Tiotropium bromide 18μg inhalation capsules once-daily'}], 'classes': [{'title': 'Very good', 'categories': [{'measurements': [{'value': '540', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Not satisfactory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)', 'description': 'Rating scale ranging from very good (best value) to not satisfactory (worst value)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Spiriva® (Tiotropium Bromide)', 'description': 'Tiotropium bromide 18μg inhalation capsules once-daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '754'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '687'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '67'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '687', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Spiriva® (Tiotropium Bromide)', 'description': 'Tiotropium bromide 18μg inhalation 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{'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 754}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'lastUpdateSubmitDate': '2016-01-13', 'studyFirstSubmitDate': '2008-01-24', 'resultsFirstSubmitDate': '2009-06-30', 'studyFirstSubmitQcDate': '2008-02-13', 'lastUpdatePostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-11-17', 'studyFirstPostDateStruct': {'date': '2008-02-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva', 'timeFrame': 'Protocol-defined treatment period between 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Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)'}], 'secondaryOutcomes': [{'measure': 'Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva', 'timeFrame': 'Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)', 'description': 'The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)'}, {'measure': 'Global Assessment of Efficacy by Patient', 'timeFrame': 'Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)', 'description': 'Rating scale ranging from very good (best value) to not satisfactory (worst value)'}, {'measure': 'Global Assessment of Tolerability by Patient', 'timeFrame': 'Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)', 'description': 'Rating scale ranging from very good (best value) to not satisfactory (worst value)'}, {'measure': 'Global Assessment of Efficacy by Physician', 'timeFrame': 'Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)', 'description': 'Rating scale ranging from very good (best value) to not satisfactory (worst value)'}, {'measure': 'Global Assessment of Tolerability by Physician', 'timeFrame': 'Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)', 'description': 'Rating scale ranging from very good (best value) to not satisfactory (worst value)'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'The primary goal of this post marketing surveillance (PMS) study is to document the efficacy of Tiotropium (Spiriva) to improve physical activity measured by a score that is recommended in national chronic obstructive pulmonary disease (COPD) guidelines for monitoring the course of the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'primary care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspected chronic obstructive pulmonary disease 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{'nctId': 'NCT00615992', 'briefTitle': 'Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines', 'orgStudyIdInfo': {'id': '205.398'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tiotropium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Admont', 'country': 'Austria', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.57537, 'lon': 14.46075}}, {'city': 'Afritz Am See', 'country': 'Austria', 'facility': 'Boehringer Ingelheim Investigational Site'}, {'city': 'Altenmarkt', 'country': 'Austria', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 46.7, 'lon': 14.71667}}, {'city': 'Altmünster', 'country': 'Austria', 'facility': 'Boehringer Ingelheim Investigational 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