Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT00281567
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2006-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-10-31', 'studyFirstSubmitDate': '2006-01-24', 'studyFirstSubmitQcDate': '2006-01-24', 'lastUpdatePostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of trough FEV1 values at the end of 4-week treatment with tiotropium inhalation solution (5 mcg, 10 mcg) to that achieved with tiotropium inhalation powder (Spiriva 18 mcg).'}], 'secondaryOutcomes': [{'measure': 'Trough forced vital capacity (FVC) response after 4 weeks (change from baseline)', 'timeFrame': 'baseline until week 28'}, {'measure': 'Peak response (FEV1 and FVC) to first dose', 'timeFrame': 'within 3 hours to first dose'}, {'measure': 'Peak response (FEV1 and FVC) after 4 weeks', 'timeFrame': 'within 3 hours after 4 weeks'}, {'measure': 'FEV1 AUC0-12h and FVC AUC0-12h response after 4 weeks', 'timeFrame': 'after 4 weeks'}, {'measure': 'FEV1 AUC0-3h and FVC AUC0-3h response after the first dose and after 4 weeks', 'timeFrame': 'after first dose and after 4 weeks'}, {'measure': 'Individual FEV1and FVC measurements at each time point', 'timeFrame': 'up to 28 weeks'}, {'measure': 'Pre-dose morning and evening peak expiratory flow rate (PEFR) measured by patients', 'timeFrame': 'up to 28 weeks'}, {'measure': 'Number of occasions of rescue therapy used as required (p.r.n. salbutamol)', 'timeFrame': 'up to 28 weeks'}, {'measure': 'Median time to onset of therapeutic response after first dose', 'timeFrame': 'after 4 weeks'}, {'measure': 'Number of patients with 15% response above baseline for each treatment at each timepoint after first dose', 'timeFrame': 'at week 4, 12, 20'}, {'measure': 'Number of patients with 15% response above baseline for each treatment at each timepoint after 4 weeks', 'timeFrame': 'at week 8, 16, 24'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of COPD\n* FEV1 \\< 60% predicted\n* FEV1 \\< 70% of FVC\n* Smoking history of 10 pack-years\n\nExclusion Criteria:\n\n* Significant other disease than COPD\n* Recent history of MI (1 year or less)\n* Cardiac arrhythmia requiring drug therapy\n* History of asthma, allergic rhinitis or eosinophil count \\> 600 mm3\n* Symptomatic prostatic hypertrophy or bladder neck obstruction\n* Known narrow-angle glaucoma\n* Abnormal baseline hematology, blood chemistry or urinalysis\n* History of cancer within last 5 years\n* Life-threatening pulmonary obstruction\n* Cystic fibrosis or bronchiectasis\n* Tuberculosis\n* Pulmonary resection'}, 'identificationModule': {'nctId': 'NCT00281567', 'briefTitle': 'Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomised, Double-blind, Double-dummy, Placebo-controlled, Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Tiotropium Inhalation Powder Capsule (18μg) Delivered by the HandiHaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': '205.250'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tiotropium', 'type': 'DRUG'}, {'name': 'Respimat SMI', 'type': 'DEVICE'}, {'name': 'HandiHaler', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Study Chairs Or Principal Investigators', 'country': 'Belgium', 'facility': 'Boehringer Ingelheim Investigational Site'}, {'city': 'Study Chairs Or Principal Investigators', 'country': 'Netherlands', 'facility': 'Boehringer Ingelheim Investigational Site'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim Study Coordinator', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim KG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}}}}