Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-30 @ 4:28 AM
Study NCT ID:
NCT00122434
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2005-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Finding Study 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'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 389}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'statusVerifiedDate': '2017-12', 'lastUpdateSubmitDate': '2017-12-27', 'studyFirstSubmitDate': '2005-07-18', 'studyFirstSubmitQcDate': '2005-07-21', 'lastUpdatePostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trough forced expiratory volume (FEV1) response after four weeks of treatment.', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Trough FEV1 response after 1 and 2 weeks', 'timeFrame': 'after 1 and 2 weeks'}, {'measure': 'Trough FVC response after 1, 2 and 4 weeks', 'timeFrame': 'after 1, 2 and 4 weeks'}, {'measure': 'FEV1, FVC AUC0-6h and peak response after 0, 1, 2 and 4 weeks', 'timeFrame': 'after 0, 1, 2 and 4 weeks'}, {'measure': 'Individual FEV1 and FVC measurements at each time point', 'timeFrame': '4 weeks'}, {'measure': 'Weekly mean pre-dose morning and evening PEFR', 'timeFrame': '4 weeks'}, {'measure': 'Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol]', 'timeFrame': '4 weeks'}, {'measure': 'COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)', 'timeFrame': '4 weeks'}, {'measure': "Physician's Global Evaluation", 'timeFrame': '4 weeks'}, {'measure': 'All adverse events', 'timeFrame': '7 weeks'}, {'measure': 'Pulse rate and blood pressure (seated) recorded in conjunction with spirometry up to the three hour pulmonary function test (PFT)', 'timeFrame': '4 weeks'}, {'measure': '12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose (Visits 2 and 5)', 'timeFrame': '4 weeks'}, {'measure': 'drug plasma concentrations', 'timeFrame': '4 or 7 weeks'}, {'measure': 'drug urine concentrations', 'timeFrame': '4 or 7 weeks'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://onlinelibrary.wiley.com/doi/10.1111/j.1440-1843.2012.02302.x/abstract', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the optimum dose of BEA 2180 BR inhalation solut ion delivered by the Respimat ? inhaler once daily for four weeks in patients with COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '83 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 \\>=30% and \\<= 60% of predicted normal and FEV1 \\<=70% of FVC at the baseline PFTs at Visit 1 (at both timepoints).\n2. All patients must have an increase in FEV1 of at least 12% from baseline (th e -10 minute measurement) 45 min after inhalation of 80 ?g Atrovent MDI.\n3. Male or female patients 40 years of age or older.\n4. Smoker or ex-smoker with a history of more than 10 pack years.\n\n1\\. Patients with any other significant disease will be excluded. 2. Patients with a history of asthma or allergic rhinitis will be excluded.'}, 'identificationModule': {'nctId': 'NCT00122434', 'briefTitle': 'Dose Finding Study in COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomized, Multiple-dose, Double-blind, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Study to Determine the Optimum Dose of BEA 2180 BR Delivered by the Respimat® Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': '1205.4'}}, 'armsInterventionsModule': {'interventions': [{'name': 'BEA 2180 BR', 'type': 'DRUG'}, {'name': 'tiotropium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Lung Health Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Vapahcs 111P', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Sepulveda', 'state': 'California', 'country': 'United States', 'facility': 'GLAHS Sepulveda', 'geoPoint': {'lat': 34.16167, 'lon': -118.28285}}, {'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Rehabilitation Clinical Trial Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'city': 'New Britain', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hospital for Special Care', 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'city': 'Bay Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Bay Pines VA Medical Center', 'geoPoint': {'lat': 27.81419, 'lon': -82.77816}}, {'city': 'Panama City', 'state': 'Florida', 'country': 'United States', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 30.15946, 'lon': -85.65983}}, {'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': 'LSUHSC - 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