Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT00239460
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2005-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-10-31', 'studyFirstSubmitDate': '2005-10-14', 'studyFirstSubmitQcDate': '2005-10-14', 'lastUpdatePostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trough FEV1 after 12 weeks of treatment', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Trough FEV1 at Visit 3', 'timeFrame': 'week 8'}, {'measure': 'Trough FVC at Visits 3 and 4', 'timeFrame': 'week 8 and week 12'}, {'measure': 'FEV1 and FVC 90 min post study drug inhalation at all visits', 'timeFrame': '90 minutes post-medication'}, {'measure': 'Use of rescue medication', 'timeFrame': '12 weeks'}, {'measure': "Patient's Global Evaluation", 'timeFrame': 'week 8 and week 12'}, {'measure': "Physician's Global Evaluation", 'timeFrame': 'week 8 and week 12'}, {'measure': 'Health Related Quality of Life assessed by the EQ5D at Visit 2 and 4', 'timeFrame': 'week 8 and week 12'}, {'measure': 'Adverse events', 'timeFrame': '12 weeks'}, {'measure': 'Vital signs', 'timeFrame': 'week 8 and week 12'}, {'measure': 'Physical Exam', 'timeFrame': 'week 12'}, {'measure': '12-lead ECG', 'timeFrame': 'week 8 and week 12'}, {'measure': '24-hour holter ECG monitoring', 'timeFrame': 'week 8 and week 12'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '25496316', 'type': 'DERIVED', 'citation': 'Hohlfeld JM, Furtwaengler A, Konen-Bergmann M, Wallenstein G, Walter B, Bateman ED. Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter-ECG data from four randomised clinical trials. Int J Clin Pract. 2015 Jan;69(1):72-80. doi: 10.1111/ijcp.12596. Epub 2014 Dec 11.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the effect of inhaled tiotropium bromide on trough FEV1 and to assess the cardiac effects through 12-lead and Holter ECG monitoring in patients with COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of COPD, FEV1 less than or equal to 65%, FEV1/FVC less than or equal 70%\n* Smoking history greater than or equal to 10 pack years\n* Not history of clinical diagnosis of asthma and/or atopy\n* A history of thoracotomy with pulmonary resection\n* Patients requiring the use of supplemental oxygen therapy for \\>12 hours per day\n* Chronic use of systemic corticosteroids in an unstable daily dose\n* Patients with a recent history of myocardial infarction\n* A known hypersensitivity to anticholinergic drugs'}, 'identificationModule': {'nctId': 'NCT00239460', 'briefTitle': 'Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With Chronic Obstructive Pulmonary Disease (a 12-week, Parallel Group, Randomized, Placebo-cotrolled, Double-blind Study).', 'orgStudyIdInfo': {'id': '205.284'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tiotropium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Attn: William C. Bailey, M.D.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'facility': 'Olive View UCLA Medical Center', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Center for Clinical Research', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'city': 'Bay Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Respiratory Diseases (111A)', 'geoPoint': {'lat': 27.81419, 'lon': -82.77816}}, {'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'city': "Coeur d'Alene", 'state': 'Idaho', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.67768, 'lon': -116.78047}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU Health Sciences Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Pulmonary and Critical Care Services, PC', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'The Oregon Clinic', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim Study Coordinator', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}}}}