Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-07 @ 9:40 PM
Study NCT ID:
NCT01810692
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2013-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Preference Tiotropium Respimat Study in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 day', 'description': 'The occurrence of adverse events was assessed from signed informed consent to the completion of the questionnaire.', 'eventGroups': [{'id': 'EG000', 'title': 'Spiriva Respimat', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.', 'otherNumAtRisk': 77, 'otherNumAffected': 0, 'seriousNumAtRisk': 77, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hirobriz/Onbrez/Oslif Breezhaler', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.', 'otherNumAtRisk': 77, 'otherNumAffected': 0, 'seriousNumAtRisk': 77, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiriva Respimat', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.'}, {'id': 'OG001', 'title': 'Hirobriz/Onbrez/Oslif Breezhaler', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.71', 'spread': '10.47', 'groupId': 'OG000'}, {'value': '79.92', 'spread': '12.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 1', 'description': 'Patient satisfaction with regard to the total score of the handling of the inhaled devices performed by means of a PASAPQ. All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the total score, the sum of the 13 items of the two domains (performance and convenience) was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from the Full Analysis Set (FAS) which includes all patients from TS who provide evaluable data for the total score of the PASAPQ.'}, {'type': 'SECONDARY', 'title': 'Total Performance PASAPQ Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiriva Respimat', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.'}, {'id': 'OG001', 'title': 'Hirobriz/Onbrez/Oslif Breezhaler', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.50', 'spread': '12.57', 'groupId': 'OG000'}, {'value': '78.20', 'spread': '15.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 1', 'description': 'All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the performance domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS.'}, {'type': 'SECONDARY', 'title': 'Total Convenience PASAPQ Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiriva Respimat', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.'}, {'id': 'OG001', 'title': 'Hirobriz/Onbrez/Oslif Breezhaler', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.62', 'spread': '11.28', 'groupId': 'OG000'}, {'value': '81.93', 'spread': '11.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 1', 'description': 'All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the convenience domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS.'}, {'type': 'SECONDARY', 'title': 'Overall Satisfaction Question', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiriva Respimat', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.'}, {'id': 'OG001', 'title': 'Hirobriz/Onbrez/Oslif Breezhaler', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.96', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '5.90', 'spread': '1.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 1', 'description': 'The overall satisfaction ranges from 1=very dissatisfied to 7=very satisfied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Spiriva Respimat', 'description': 'Patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.'}, {'id': 'FG001', 'title': 'Hirobriz/Onbrez/Oslif Breezhaler', 'description': 'Patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Spiriva Respimat', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.'}, {'id': 'BG001', 'title': 'Hirobriz/Onbrez/Oslif Breezhaler', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.7', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '67.0', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '68.4', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time since diagnosis of COPD', 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '5.9', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '6.1', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Patients from the Treated Set (TS) who reported information about the last prescription of inhalation devices before the start of the study.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-16', 'studyFirstSubmitDate': '2013-03-12', 'resultsFirstSubmitDate': '2015-03-16', 'studyFirstSubmitQcDate': '2013-03-12', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-16', 'studyFirstPostDateStruct': {'date': '2013-03-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ)', 'timeFrame': 'day 1', 'description': 'Patient satisfaction with regard to the total score of the handling of the inhaled devices performed by means of a PASAPQ. All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the total score, the sum of the 13 items of the two domains (performance and convenience) was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.'}], 'secondaryOutcomes': [{'measure': 'Total Performance PASAPQ Score.', 'timeFrame': 'day 1', 'description': 'All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the performance domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.'}, {'measure': 'Total Convenience PASAPQ Score', 'timeFrame': 'day 1', 'description': 'All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the convenience domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.'}, {'measure': 'Overall Satisfaction Question', 'timeFrame': 'day 1', 'description': 'The overall satisfaction ranges from 1=very dissatisfied to 7=very satisfied.'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': "In COPD the patient's ability to use inhalers correctly and their preference for the inhaler are both important factors in selecting an appropriate treatment for COPD. This is a cross-sectional study where satisfaction, preference and handling of two different devices such as Respimat and Breezhaler will be evaluated by using the validated PASAPQ in COPD patients", 'detailedDescription': 'Purpose:\n\nStudy Design:'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'COPD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. All patients must sign an informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the study and conducting any study procedures.\n2. Adult male or female patients with chronic obstructive pulmonary disease (COPD) for less than a year who follow usual clinical practice of the participant sites and who are on treatment with Spiriva® Respimat®, Hirobriz® Breezhaler® / Onbrez® Breezhaler® / Oslif® Breezhaler® for at least of 3 months but not more than maximum of 6 months before the informed consent date.\n\nExclusion criteria:\n\n1. Previously included in this study or currently participating in another interventional study.\n2. Visual, cognitive, or motor impairment that as judged by the investigator does not allow the patient to independently read and complete the questionnaire.\n3. Patients who are treated simultaneously with both respiratory medications (Spiriva® Respimat® and Hirobriz® Breezhaler® / Onbrez® Breezhaler® / Oslif® Breezhaler®).'}, 'identificationModule': {'nctId': 'NCT01810692', 'briefTitle': 'Preference Tiotropium Respimat Study in COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Cross-sectional Study to Assess the Handling , Patient Satisfaction, and Preference for Inhalation Devices in Patients With Chronic Obstructive Pulmonary Disease (COPD).', 'orgStudyIdInfo': {'id': '205.514'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Device: Group1:Spiriva® Respimat®']}, {'label': 'Group 2', 'interventionNames': ['Device: Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler®']}], 'interventions': [{'name': 'Group1:Spiriva® Respimat®', 'type': 'DEVICE', 'description': 'COPD patients using Respimat®', 'armGroupLabels': ['Group 1']}, {'name': 'Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler®', 'type': 'DEVICE', 'description': 'COPD patients using Breezhaler®®', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'A Coruña', 'country': 'Spain', 'facility': 'Boehringer Ingelheim Investigational Site 13', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Boehringer Ingelheim Investigational Site 5', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Boehringer Ingelheim Investigational Site 6', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Boehringer Ingelheim Investigational Site 8', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Burgos', 'country': 'Spain', 'facility': 'Boehringer Ingelheim Investigational Site 12', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'city': 'Galdako.', 'country': 'Spain', 'facility': 'Boehringer Ingelheim Investigational Site 14'}, {'city': 'Laredo', 'country': 'Spain', 'facility': 'Boehringer Ingelheim Investigational Site 11', 'geoPoint': {'lat': 43.4098, 'lon': -3.41613}}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'Boehringer Ingelheim Investigational Site 1', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Mérida', 'country': 'Spain', 'facility': 'Boehringer Ingelheim Investigational Site 3', 'geoPoint': {'lat': 38.91802, 'lon': -6.34292}}, {'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'Boehringer Ingelheim Investigational Site 15', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'city': 'Pozuelo de Alarcón', 'country': 'Spain', 'facility': 'Boehringer Ingelheim Investigational Site 9', 'geoPoint': {'lat': 40.43293, 'lon': -3.81338}}, {'city': 'Sabadell', 'country': 'Spain', 'facility': 'Boehringer Ingelheim Investigational Site 7', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Boehringer Ingelheim Investigational Site 2', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Torrelodones', 'country': 'Spain', 'facility': 'Boehringer Ingelheim Investigational Site 10', 'geoPoint': {'lat': 40.57654, 'lon': -3.92658}}, {'city': 'Villanueva de la Serena', 'country': 'Spain', 'facility': 'Boehringer Ingelheim Investigational Site 4', 'geoPoint': {'lat': 38.97655, 'lon': -5.7974}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}