Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-24 @ 4:29 AM
Study NCT ID:
NCT02172560
Status:
COMPLETED
Last Update Posted:
2014-11-18
First Post:
2014-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Collection of Vital Status and Pulmonary Medication Usage Data for Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Withdrew Prematurely From Tiotropium Inhalation Solution Delivered by the Respimat Inhaler
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 441}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-11-17', 'studyFirstSubmitDate': '2014-06-20', 'studyFirstSubmitQcDate': '2014-06-23', 'lastUpdatePostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and status of patients dead or alive at the predicted end of treatment date', 'timeFrame': 'Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death'}], 'secondaryOutcomes': [{'measure': 'Number and specification of patients on pulmonary medications and other pulmonary interventions', 'timeFrame': 'Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': "The objectives were to collect information on vital status and pulmonary medication use at the predicted exit date for patients who participated in two one-year trials and withdrew prematurely. The primary objective was to ascertain the vital status (dead or alive) of these patients in the time interval between the patients' withdrawal from the trial and their predicted exit date (i.e: 48 weeks from first intake of randomised treatment + 30 days). The secondary objective was to collect information on classes of pulmonary medication and some other specified pulmonary interventions used by these prematurely discontinued patients at the time of their predicted exit date (i.e 48 weeks from the first intake of randomised treatment + 30 days) or at date of death (if this occurred during the time interval of interest, i.e 48 weeks from the first intake of randomised treatment + 30 days)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with COPD who withdrew prematurely from the randomised treatment phases of studies 205.254 and 205.255', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who withdrew prematurely from the randomised treatment phase of studies 205.254 and 205.255.\n\nExclusion Criteria:\n\n* Not applicable.'}, 'identificationModule': {'nctId': 'NCT02172560', 'briefTitle': 'A Collection of Vital Status and Pulmonary Medication Usage Data for Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Withdrew Prematurely From Tiotropium Inhalation Solution Delivered by the Respimat Inhaler', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Retrospective Collection of Vital Status and Pulmonary Medication Usage Data for Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Withdrew Prematurely From Either of Two One-Year Trials (205.254, 205.255) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler', 'orgStudyIdInfo': {'id': '205.392'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Premature withdrawal from tiotropium', 'interventionNames': ['Drug: Tiotropium']}], 'interventions': [{'name': 'Tiotropium', 'type': 'DRUG', 'armGroupLabels': ['Premature withdrawal from tiotropium']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Garran', 'state': 'Australian Capital Territory', 'country': 'Australia', 'facility': 'Boehringer Ingelheim Investigational Site 61501', 'geoPoint': {'lat': -35.34206, 'lon': 149.10846}}, {'city': 'Clayton', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Boehringer Ingelheim Investigational Site 61403'}, {'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Boehringer Ingelheim Investigational Site 61502', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Woodsville South', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Boehringer Ingelheim Investigational Site 61401'}, {'city': 'Frankston', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Boehringer Ingelheim Investigational Site 61402', 'geoPoint': {'lat': -38.14458, 'lon': 145.12291}}, {'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Boehringer Ingelheim Investigational Site 61503', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Boehringer Ingelheim Investigational Site 61405', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Boehringer Ingelheim Investigational Site 61505', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'city': 'Otahuhu', 'country': 'New Zealand', 'facility': 'Boehringer Ingelheim Investigational Site 61504', 'geoPoint': {'lat': -36.9382, 'lon': 174.84019}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Boehringer Ingelheim Investigational Site 44402', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Boehringer Ingelheim Investigational Site 44409', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Devon', 'country': 'United Kingdom', 'facility': 'Boehringer Ingelheim Investigational Site 44502'}, {'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Boehringer Ingelheim Investigational Site 44504', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'city': 'Isleworth', 'country': 'United Kingdom', 'facility': 'Boehringer Ingelheim Investigational Site 44507', 'geoPoint': {'lat': 51.47518, 'lon': -0.34246}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Boehringer Ingelheim Investigational Site 44506', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Boehringer Ingelheim Investigational Site 44403', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'city': 'Swansea', 'country': 'United Kingdom', 'facility': 'Boehringer Ingelheim Investigational Site 44405', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}, {'city': 'Torquay', 'country': 'United Kingdom', 'facility': 'Boehringer Ingelheim Investigational Site 44404', 'geoPoint': {'lat': 50.46198, 'lon': -3.52522}}, {'city': 'Torquay', 'country': 'United Kingdom', 'facility': 'Boehringer Ingelheim Investigational Site 44505', 'geoPoint': {'lat': 50.46198, 'lon': -3.52522}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}