Viewing Study NCT02177318


Ignite Creation Date: 2025-12-25 @ 4:59 AM
Ignite Modification Date: 2026-03-06 @ 4:05 PM
Study NCT ID: NCT02177318
Status: COMPLETED
Last Update Posted: 2014-06-27
First Post: 2008-01-31
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Tiotropium in the Treatment of the Patients With Chronic Obstructive Pulmonary Disease
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'}, {'id': 'D001239', 'term': 'Inhalation'}], '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'}, {'id': 'D015656', 'term': 'Respiratory Mechanics'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3588}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-06-26', 'studyFirstSubmitDate': '2008-01-31', 'studyFirstSubmitQcDate': '2014-06-26', 'lastUpdatePostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with adverse events', 'timeFrame': 'Up to 4 weeks after start of treatment'}, {'measure': 'Number of patients with adverse drug reactions', 'timeFrame': 'Up to 4 weeks after start of treatment'}, {'measure': 'Number of patients with serious adverse events', 'timeFrame': 'Up to 4 weeks after start of treatment'}], 'secondaryOutcomes': [{'measure': "Physician's overall judgement by medical interview into four grades: 1. Improved 2. No Change 3. Aggravated 4.Unassessable", 'timeFrame': 'Up to 4 weeks after start of treatment'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'To collect post-marketing safety and effectiveness information on the use of Tiotropium Inhalation Capsules (18 μg) in patients with chronic obstructive pulmonary disease in daily clinical settings'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD patients in daily clinical settings.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients with COPD\n\nExclusion Criteria:\n\n-There is no exclusion criterion, because this post marketing study (PMS) is observational survey under condition of normal clinical practice'}, 'identificationModule': {'nctId': 'NCT02177318', 'acronym': 'COPD', 'briefTitle': 'Tiotropium in the Treatment of the Patients With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Drug Use Results Survey of Tiotropium Bromide', 'orgStudyIdInfo': {'id': '205.314'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with COPD', 'interventionNames': ['Drug: Spiriva (tiotropium bromide) inhalation capsules']}], 'interventions': [{'name': 'Spiriva (tiotropium bromide) inhalation capsules', 'type': 'DRUG', 'description': 'Survey of patients with COPD using Spiriva (tiotropium bromide) inhalation capsules', 'armGroupLabels': ['Patients with COPD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abashiri', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 44.02127, 'lon': 144.26971}}, {'city': 'Aizu-Wakamatsu', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 37.49142, 'lon': 139.94546}}, {'city': 'Aizubangemachi', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site'}, {'city': 'Aizumisatomachi', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site'}, {'city': 'Akashi', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 34.65524, 'lon': 135.00687}}, {'city': 'Akita', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'city': 'Akō', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.55, 'lon': 137.25}}, {'city': 'Amagasaki', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 34.71667, 'lon': 135.41667}}, {'city': 'Amakusa', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.45861, 'lon': 130.19306}}, {'city': 'Amimachi', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site'}, {'city': 'Anan', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.91667, 'lon': 134.65}}, {'city': 'Anjo', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 34.95828, 'lon': 137.08054}}, {'city': 'Arakawamachi', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site'}, {'city': 'Arao', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.97888, 'lon': 130.44572}}, {'city': 'Aritacho', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site'}, {'city': 'Asahikawa', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'city': 'Ashikaga', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 36.33333, 'lon': 139.45}}, {'city': 'Atami', 'country': 'Japan', 'facility': 'Boehringer Ingelheim 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'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.48933, 'lon': 138.68832}}, {'city': 'Fujinomiya', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.21667, 'lon': 138.61667}}, {'city': 'Fukagawa', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.70806, 'lon': 142.03917}}, {'city': 'Fukaya', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 38.47019, 'lon': 141.06305}}, {'city': 'Fukuchiyama', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.3, 'lon': 135.11667}}, {'city': 'Fukui', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 34.84214, 'lon': 135.54836}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 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