Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT00274560
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2006-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol.
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': 'D000068299', 'term': 'Salmeterol Xinafoate'}], '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': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 653}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2006-01-09', 'studyFirstSubmitQcDate': '2006-01-09', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12)', 'timeFrame': '12 weeks'}, {'measure': 'peak FEV1', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Trough FEV1: Trough FEV1 was the FEV1 measured prior to dosing', 'timeFrame': '12 weeks'}, {'measure': 'Trough and peak FVC and FVC AUC0-12 measured at the same times as FEV1 on each test day', 'timeFrame': '12 weeks'}, {'measure': 'Individual FEV1 and FVC measurements at each timepoint', 'timeFrame': '12 weeks'}, {'measure': 'Number (%) of patients with at least one exacerbation of COPD', 'timeFrame': '12 weeks'}, {'measure': 'time to first exacerbation', 'timeFrame': '12 weeks'}, {'measure': 'number of exacerbations', 'timeFrame': '12 weeks'}, {'measure': 'number of exacerbation days', 'timeFrame': '12 weeks'}, {'measure': 'Average daily occasions of rescue medication [albuterol (salbutamol)] use each week', 'timeFrame': '12 weeks'}, {'measure': 'All adverse events', 'timeFrame': '12 weeks'}, {'measure': 'Pulse rate measured in conjunction with spirometry', 'timeFrame': '12 weeks'}, {'measure': 'Blood pressure (seated) measured in conjunction with spirometry', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'The objective of the study was to evaluate the degree of improvement in lung function in patients with chronic obstructive pulmonary disease (COPD) after treatment with tiotropium inhalation capsules compared to salmeterol inhalation aerosol .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Ability to sign a written Informed Consent Form consistent with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial (i.e., prior to any study procedures, including any pre-study washout of medications).\n* Age of 40 years or older.\n* Smoking history of ≥10 pack-years.\n* A diagnosis of relatively stable chronic obstructive pulmonary disease with an Forced expiratory volume in one second (FEV1) ≤60% of predicted normal and FEV1 ≤70% of Forced vital capacity (FVC).\n* Ability to perform technically acceptable pulmonary function tests, and ability to maintain records during the study period as required in the protocol.\n* Ability to inhale medication from the HandiHaler® and from a metered dose inhaler.\n\nExclusion criteria:\n\n* Clinically significant diseases other than Chronic obstructive pulmonary disease (COPD). A clinically significant disease was defined as a disease or condition which, in the opinion of the investigator, could have put the patient at risk because of participation in the study or may have influenced either the results of the study or the patient's ability to participate in the study.\n* Known moderate or severe renal insufficiency.\n* A recent history (i.e., six months or less) of myocardial infarction.\n* Unstable or life-threatening cardiac arrhythmias, including newly diagnosed, clinically relevant arrhythmia on the electrocardiogram (ECG) performed on Visit 1. Unstable arrhythmias included arrhythmias that required an intervention (i.e., hospitalization, cardioversion, pacemaker placement, and automatic implantable cardiac defibrillator (AICD) placement) or a change in drug therapy during the year preceding study enrollment.\n* Hospitalization for heart failure during the past three years.\n* History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.\n* Other exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT00274560', 'briefTitle': 'A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol in a 12 Week, Randomized, Double-Blind, Double-Dummy Parallel Group Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).', 'orgStudyIdInfo': {'id': '205.264'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tiotropium', 'type': 'DRUG'}, {'name': 'Salmeterol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Medical Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Jasper', 'state': 'Alabama', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.83122, 'lon': -87.27751}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southern Arizona VA Health Care System', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'city': 'Sepulveda', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los angeles Health Care Systems', 'geoPoint': {'lat': 34.16167, 'lon': -118.28285}}, {'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'facility': 'Olive View UCLA Medical Center', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Pulmonary Associates', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'University Medical Associates, LLP', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'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 MC-Sheveport', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'The Oregon Clinic', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University School of Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Attention: Thomas D. 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