Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT00240435
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2005-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 491}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-10-31', 'studyFirstSubmitDate': '2005-10-14', 'studyFirstSubmitQcDate': '2005-10-14', 'lastUpdatePostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trough FEV1 response after 12 weeks of treatment.', 'timeFrame': 'after 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Trough FEV1 response', 'timeFrame': 'after 1, 4 and 8 weeks'}, {'measure': 'Trough FVC response', 'timeFrame': 'after 1, 4, 8 and 12 weeks'}, {'measure': 'FEV1 and FVC area under the curve and peak response', 'timeFrame': 'after 0, 1, 4, 8 and 12 weeks'}, {'measure': 'Individual FEV1 and FVC measurements at each time point', 'timeFrame': 'during study course of 12 weeks'}, {'measure': 'Therapeutic response and percentage of responders', 'timeFrame': 'after 0 and 12 weeks'}, {'measure': 'Weekly mean pre-dose morning and evening PEFR', 'timeFrame': 'during study course of 12 weeks'}, {'measure': 'Number of occasions of rescue therapy used per day (PRN salbutamol)', 'timeFrame': 'during study course of 12 weeks'}, {'measure': 'COPD symptom scores', 'timeFrame': 'during 15 weeks'}, {'measure': "Physician's Global Evaluation", 'timeFrame': 'during 15 weeks'}, {'measure': 'Number of patients with at least one exacerbation of COPD', 'timeFrame': '15 weeks'}, {'measure': 'time to first exacerbation', 'timeFrame': '15 weeks'}, {'measure': 'number of exacerbations', 'timeFrame': '15 weeks'}, {'measure': 'number of exacerbation days', 'timeFrame': '15 weeks'}, {'measure': 'Patient satisfaction and preference', 'timeFrame': '12 weeks'}, {'measure': 'All adverse events', 'timeFrame': 'during 15 weeks, follow-up period included'}, {'measure': 'Pulse rate and blood pressure for the first three hours following dosing', 'timeFrame': 'after 0, 1, 4, 8 and 12 weeks'}, {'measure': 'Routine blood chemistry, haematology and urinalysis', 'timeFrame': 'after 12 weeks'}, {'measure': '12-lead ECG', 'timeFrame': 'after 12 weeks'}, {'measure': 'Physical examination', 'timeFrame': 'after 12 weeks'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Outpatients of either sex, aged \\>/= 40 years with a diagnosis of COPD (FEV1 \\</= 60% predicted \\[ECCS criteria\\] and FEV1/FVC \\</= 70%)'}, 'identificationModule': {'nctId': 'NCT00240435', 'briefTitle': '12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison of 12-week Treatment of Two Doses (5 Mcg and 10 Mcg) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) i', 'orgStudyIdInfo': {'id': '205.252'}}, 'armsInterventionsModule': {'interventions': [{'name': '5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler', 'type': 'DEVICE'}, {'name': '10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California - Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'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': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 27.81419, 'lon': -82.77816}}, {'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'city': 'Wheaton', 'state': 'Maryland', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.03983, 'lon': -77.05526}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'city': 'Elizabeth City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 36.2946, 'lon': -76.25105}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'St. Boniface General Hospital', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'city': 'Courtice', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.91682, 'lon': -78.76626}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Hospital Cardiac Research", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Department of Respiratory Medicine', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'SMBD--Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de Recherche Clinique -CUSE', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'city': 'Ste-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Laval'}, {'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'c/o Hemodynamics Offices', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim Study Coordinator', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}}}}