Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2026-02-24 @ 8:26 AM
Study NCT ID:
NCT02172495
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2014-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spiriva® in Patients With Chronic Obstructive Pulmonary Disease (COPD) in Daily Practice
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'lastUpdateSubmitDate': '2018-08-29', 'studyFirstSubmitDate': '2014-06-20', 'studyFirstSubmitQcDate': '2014-06-20', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in breathlessness when walking/climbing stairs', 'timeFrame': 'Baseline, after 4 weeks'}, {'measure': 'Change from baseline in breathlessness on physical exercise', 'timeFrame': 'Baseline, after 4 weeks'}, {'measure': 'Change from baseline in breathlessness during everyday activities', 'timeFrame': 'Baseline, after 4 weeks'}, {'measure': 'Change from baseline in breathlessness during housework', 'timeFrame': 'Baseline, after 4 weeks'}, {'measure': 'Change from baseline in overall severity of the clinical picture', 'timeFrame': 'Baseline, after 4 weeks'}, {'measure': 'Occurrence of Adverse Events', 'timeFrame': '4 weeks'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'Post-marketing surveillance to gather information regarding the tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of daily practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged at least 40 years with the symptoms of Chronic Obstructive Pulmonary Disease\n\nExclusion Criteria:\n\n* Patients with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information'}, 'identificationModule': {'nctId': 'NCT02172495', 'briefTitle': 'Spiriva® in Patients With Chronic Obstructive Pulmonary Disease (COPD) in Daily Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Tolerability and Efficacy of Spiriva® 18 Micrograms in Patients With COPD in Daily Practice', 'orgStudyIdInfo': {'id': '205.278'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Symptoms of COPD', 'description': 'Patients with symptoms of COPD receiving Tiotropium bromide 18 micrograms', 'interventionNames': ['Drug: Tiotropium bromide']}], 'interventions': [{'name': 'Tiotropium bromide', 'type': 'DRUG', 'otherNames': ['Spiriva®'], 'description': 'Tiotropium bromide 18 micrograms', 'armGroupLabels': ['Symptoms of COPD']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}