Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 1:48 AM
Study NCT ID:
NCT04011735
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2019-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Re-usable Respimat® Soft MistTM Inhaler Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069447', 'term': 'Tiotropium Bromide'}, {'id': 'C549647', 'term': 'olodaterol'}, {'id': 'C000611386', 'term': 'tiotropium-olodaterol'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': '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': 'From study entry until end of study, up to 6 weeks.', 'description': 'Full Analysis Set (FAS): All enrolled patients who met all the eligibility criteria of the study and who had received at least one dose of ther re-usable Respimat SMI product during the study period.', 'eventGroups': [{'id': 'EG000', 'title': 'Respimat® SMI-experienced: Maintenance With Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).', 'otherNumAtRisk': 133, 'deathsNumAtRisk': 133, 'otherNumAffected': 0, 'seriousNumAtRisk': 133, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Respimat® SMI-experienced: Switching to Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 0, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Respimat® SMI-naïve', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Total Patient Satisfaction and Preference Questionnaire (PASAPQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Respimat® SMI-experienced: Maintenance With Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).'}, {'id': 'OG001', 'title': 'Respimat® SMI-experienced: Switching to Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).'}, {'id': 'OG002', 'title': 'Respimat® SMI-naïve', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).'}], 'classes': [{'categories': [{'measurements': [{'value': '84.26', 'groupId': 'OG000', 'lowerLimit': '82.69', 'upperLimit': '85.82'}, {'value': '81.59', 'groupId': 'OG001', 'lowerLimit': '78.71', 'upperLimit': '84.47'}, {'value': '83.24', 'groupId': 'OG002', 'lowerLimit': '79.89', 'upperLimit': '86.59'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At follow-up assessment, 4 to 6 weeks after baseline.', 'description': "Total PASAPQ score is a measure of patient's satisfaction regarding the handling of the re-usable Respimat® SMI. The total score was the sum of the 13 items related to Performance and Convenience PASAPG domains (7 items for Performance domain: Q 1-5, 10-11, and 6 items for convenience domain: Q6-9, 12-13).\n\nEach PASAPQ item had response options ranging from 1 (very dissatisfied) to 7 (very satisfied). To calculate the total and domain score, the items within each domain were first summed and then transformed to a 0 (least) or 100 (most) point scale, with higher scores indicating greater satisfaction:\n\nPerformance score = 100 \\*\\[(Q1+Q2 +Q3+ Q4+Q5+Q10+Q11)-7\\] /(49-7)\n\nConvenience score = 100 \\*\\[(Q6+ Q7+Q8+Q9+Q12+Q13)-6\\] / (42-6)\n\nTotal score = 100 \\*\\[(Q1+Q2 +Q3+Q4+ Q5+Q6 + Q7+Q8+ Q9+Q10+Q11+Q12+Q13)-13\\] / (91-13)", 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the Full Analysis Set (FAS) who have available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Total Performance PASAPQ Score for All Patients at Study End (Follow-up Assessment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Respimat® SMI-experienced: Maintenance With Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).'}, {'id': 'OG001', 'title': 'Respimat® SMI-experienced: Switching to Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).'}, {'id': 'OG002', 'title': 'Respimat® SMI-naïve', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).'}], 'classes': [{'categories': [{'measurements': [{'value': '84.70', 'spread': '12.647', 'groupId': 'OG000'}, {'value': '82.88', 'spread': '14.938', 'groupId': 'OG001'}, {'value': '82.38', 'spread': '16.288', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At follow-up assessment, 4 to 6 weeks after baseline.', 'description': 'The performance domain score of PASAPQ contained 7 items (Q 1-5 and 10-11), each item had response options ranging from 1 (very dissatisfied) to 7 (very satisfied). To calculate the domain score, the items were first summed and then transformed to a 0 (least) to 100 (most) point scale, with higher scores indicating greater satisfaction:\n\nPerformance score = 100 \\* \\[(Q1+ Q2+Q3+Q4+Q5+Q10+Q11)-7\\] / (49-7)', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the Full Analysis Set (FAS) who have available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Total Convenience PASAPQ Score for All Patients at Study End (Follow-up Assessment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Respimat® SMI-experienced: Maintenance With Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).'}, {'id': 'OG001', 'title': 'Respimat® SMI-experienced: Switching to Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).'}, {'id': 'OG002', 'title': 'Respimat® SMI-naïve', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).'}], 'classes': [{'categories': [{'measurements': [{'value': '83.74', 'spread': '10.799', 'groupId': 'OG000'}, {'value': '80.08', 'spread': '15.075', 'groupId': 'OG001'}, {'value': '84.24', 'spread': '14.434', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At follow-up assessment, 4 to 6 weeks after baseline.', 'description': 'The convenience domain score of PASAPQ contained 6 items (Question 6-9 and 12-13), each item had response options ranging from 1 (very dissatisfied) to 7 (very satisfied). To calculate the domain score, the items were first summed and then transformed to a 0 (least) to 100 (most) point scale, with higher scores indicating greater satisfaction:\n\nConvenience score = 100 \\* \\[(Q6+Q7+Q8+Q9+Q12+Q13)-6\\] / (42-6)', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the Full Analysis Set (FAS) who have available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Overall Satisfaction Question With Inhaler for All Patients at Study End (Follow-up Assessment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Respimat® SMI-experienced: Maintenance With Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).'}, {'id': 'OG001', 'title': 'Respimat® SMI-experienced: Switching to Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).'}, {'id': 'OG002', 'title': 'Respimat® SMI-naïve', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).'}], 'classes': [{'categories': [{'title': 'Very dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Somewhat dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Somewhat satisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Satisfied', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}, {'title': 'Very Satisified', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At follow-up assessment, 4 to 6 weeks after baseline.', 'description': 'The overall satisfaction score of the PASAPQ asked for the overall satisfaction with the device used in the study (Question 14), answered using a 7-point scale ranging from 1 (very dissatisfied) to 7 (very satisfied). Reported is the number of patients by category.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the Full Analysis Set (FAS) who have available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Question on Willingness to Continue With Inhaler for All Patients at Study End (Follow-up Assessment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Respimat® SMI-experienced: Maintenance With Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).'}, {'id': 'OG001', 'title': 'Respimat® SMI-experienced: Switching to Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).'}, {'id': 'OG002', 'title': 'Respimat® SMI-naïve', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).'}], 'classes': [{'categories': [{'measurements': [{'value': '89.1', 'spread': '19.23', 'groupId': 'OG000'}, {'value': '88.0', 'spread': '19.29', 'groupId': 'OG001'}, {'value': '84.1', 'spread': '22.98', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At follow-up assessment, 4 to 6 weeks after baseline.', 'description': 'To assess the willingness to continue with inhaler, the following questions was asked: "How would you feel about continuing to use the inhaler?", using a value from 0-100, with zero indicating that the patient is not willing to continue using the inhaler and 100 indicating that the patient is definitely willing to continue using the inhaler.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the Full Analysis Set (FAS) who have available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Respimat® SMI-experienced: Maintenance With Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).'}, {'id': 'OG001', 'title': 'Respimat® SMI-experienced: Switching to Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).'}, {'id': 'OG002', 'title': 'Respimat® SMI-naïve', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).'}], 'classes': [{'title': 'Q1: How satisfied are you with the ease of removing the clear base?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Very dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Somewhat dissatisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Somewhat satisfied', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'Satisfied', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}, {'title': 'Very satisfied', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}, {'title': 'Not applicable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Q2: How satisfied are you with the grip of the cartridge?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Very dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Somewhat dissatisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Somewhat satisfied', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Satisfied', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}, {'title': 'Very satisfied', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}, {'title': 'Not applicable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Q3: How satisfied are you with inserting a new cartridge?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Very dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Somewhat dissatisfied', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Somewhat satisfied', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'Satisfied', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}, {'title': 'Very satisfied', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}, {'title': 'Not applicable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Q4: How satisfied are you with the readability of the dose indicator?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Very dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Somewhat dissatisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Somewhat satisfied', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Satisfied', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}, {'title': 'Very satisfied', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}, {'title': 'Not applicable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Q5: How satisfied are you with recognising when you need to replace the cartridge?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Very dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Somewhat dissatisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Somewhat satisfied', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Satisfied', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}, {'title': 'Very satisfied', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}, {'title': 'Not applicable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Q6: How satisfied are you with automatic detachment of the clear base when the cartridge is empty?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Very dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Somewhat dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Somewhat satisfied', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'Satisfied', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}, {'title': 'Very satisfied', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}, {'title': 'Not applicable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Q7: How satisfied are you with automatic return to start-use position when replacing the clear base?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Very dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Somewhat dissatisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': 'Somewhat satisfied', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Satisfied', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}, {'title': 'Very satisfied', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}, {'title': 'Not applicable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Q8: How satisfied are you with the overall ease of handling the inhaler?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Very dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Somewhat dissatisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Somewhat satisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Satisfied', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}, {'title': 'Very satisfied', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}, {'title': 'Not applicable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Q9: How satisfied are you with the sustainability concept of the inhaler, due to re-use ability?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Very dissatisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Somewhat dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Somewhat satisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'Satisfied', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}, {'title': 'Very satisfied', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}, {'title': 'Not applicable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Q10: How satisfied are you with recognising when to replace the inhaler?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Very dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Somewhat dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Somewhat satisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Satisfied', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}, {'title': 'Very satisfied', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}, {'title': 'Not applicable', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At follow-up assessment, 4 to 6 weeks after baseline.', 'description': '10 Questions regarding the Ease of Handling were asked, using a 7 point scale ranging from 1 (very dissatisfied) to 7 (very satisfied). Reported is the number of patients by answer category.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): All enrolled patients who met all the eligibility criteria of this study and who had received at least one dose of their re-usable Respimat SMI product during the study. Missing patients did not perform the Follow-up assesment or who did not perform the Ease of Handling assessment at Follow-Up assessment.'}, {'type': 'SECONDARY', 'title': 'Difference in the Mean Total PASAPQ Score Between Study Entry and Study End in Respimat SMI-experienced Patients Who Switched From a Disposable to a Re-usable Respimat SMI Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Respimat® SMI-experienced: Switching to Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.10', 'spread': '10.034', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At study entry (baseline) and at study end (4 to 6 weeks after baseline).', 'description': 'Difference in the mean Total PASAPQ score between study entry (baseline visit) and at study end (follow-up assessment) in Respimat SMI-experienced patients who switched from a disposable to a re-usable Respimat SMI product at study entry.\n\nThe total score was the sum of the 13 items related to Performance and Convenience PASAPG domains (7 items for Performance domain: Q 1-5, 10-11, and 6 items for convenience domain: Q6-9, 12-13).\n\nEach PASAPQ item had response options ranging from 1 (very dissatisfied) to 7 (very satisfied). To calculate the total and domain score, the items within each domain were first summed and then transformed to a 0 (least) or 100 (most) point scale, with higher scores indicating greater satisfaction.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: Respimat SMI-experience patients who switched from a disposable to a re-usable Respimat SMI product at study entry and with available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Preference for Re-usable or Disposable Respimat SMI at Study End in Respimat SMI-experienced Patients Who Switched From a Disposable to a Re-usable Respimat SMI Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Respimat SMI-experienced Patients Switching to a Re-usable Respimat SMI at Study Entry', 'description': 'Respimat SMI-experienced patients switching to a re-usable Respimat SMI at study entry.'}], 'classes': [{'categories': [{'title': 'Re-usable inhaler', 'measurements': [{'value': '57', 'groupId': 'OG000'}]}, {'title': 'Disposable inhaler', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'No preference', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At follow-up assessment, 4 to 6 weeks after baseline.', 'description': 'Number of patients with preference for re-usable or disposable Respimat SMI at study end (follow-up assessment), in Respimat SMI-experienced patients who switched from a disposable to a re-usable Respimat SMI product at study entry. To assess the preference for inhaler, following question was asked: "Comparing the re-usable with disposable inhaler, which inhaler do you prefer to use?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: Respimat SMI-experience patients who switched from a disposable to a re-usable Respimat SMI product at study entry and with available data for this endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Respimat® SMI-experienced: Maintenance With Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).'}, {'id': 'FG001', 'title': 'Respimat® SMI-experienced: Switching to Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).'}, {'id': 'FG002', 'title': 'Respimat® SMI-naïve', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Met exclusion criteria after study entry', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A real-world, non-interventional study to assess the satisfaction of chronic obstructive pulmonary disease (COPD) patients with inhaler attributes and preferences for re-usable Respimat® Soft Mist Inhaler (SMI).', 'preAssignmentDetails': '262 patients were enrolled into the study, whereof 2 patients were enrolment failures as they did not meet eligibility criteria or received a disposable inhaler. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '259', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Respimat® SMI-experienced: Maintenance With Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a re-usable Respimat Sof Mist Inhaler (SMI) product (Spiriva®, Striverdi®, or Spiolto®) at study entry. Patients were followed from the time of study entry (enrollment visit) for a period of approximately 4 to 6 weeks (study period).'}, {'id': 'BG001', 'title': 'Respimat® SMI-experienced: Switching to Re-usable SMI', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).'}, {'id': 'BG002', 'title': 'Respimat® SMI-naïve', 'description': 'Chronic obstructive pulmonary disease (COPD) patients who had not previously used a Respimat SMI product and had received their first prescription for a re-usable Respimat SMI product at study entry. Patients were followed from the time of study entry (enrolment visit) for a period of approximately 4 to 6 weeks (study period).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.1', 'spread': '7.59', 'groupId': 'BG000'}, {'value': '68.6', 'spread': '8.58', 'groupId': 'BG001'}, {'value': '68.7', 'spread': '7.69', 'groupId': 'BG002'}, {'value': '68.9', 'spread': '7.86', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '253', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '255', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS): All enrolled patients who met all the eligibilty criteria of the study and who had received at least one dose of ther re-usable Respimat SMI product during the study period.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-11', 'size': 625163, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-05T05:09', 'hasProtocol': True}, {'date': '2019-10-10', 'size': 2837987, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-02-05T05:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 262}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-11', 'studyFirstSubmitDate': '2019-07-04', 'resultsFirstSubmitDate': '2021-02-11', 'studyFirstSubmitQcDate': '2019-07-04', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-11', 'studyFirstPostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Total Patient Satisfaction and Preference Questionnaire (PASAPQ) Score', 'timeFrame': 'At follow-up assessment, 4 to 6 weeks after baseline.', 'description': "Total PASAPQ score is a measure of patient's satisfaction regarding the handling of the re-usable Respimat® SMI. The total score was the sum of the 13 items related to Performance and Convenience PASAPG domains (7 items for Performance domain: Q 1-5, 10-11, and 6 items for convenience domain: Q6-9, 12-13).\n\nEach PASAPQ item had response options ranging from 1 (very dissatisfied) to 7 (very satisfied). To calculate the total and domain score, the items within each domain were first summed and then transformed to a 0 (least) or 100 (most) point scale, with higher scores indicating greater satisfaction:\n\nPerformance score = 100 \\*\\[(Q1+Q2 +Q3+ Q4+Q5+Q10+Q11)-7\\] /(49-7)\n\nConvenience score = 100 \\*\\[(Q6+ Q7+Q8+Q9+Q12+Q13)-6\\] / (42-6)\n\nTotal score = 100 \\*\\[(Q1+Q2 +Q3+Q4+ Q5+Q6 + Q7+Q8+ Q9+Q10+Q11+Q12+Q13)-13\\] / (91-13)"}], 'secondaryOutcomes': [{'measure': 'Total Performance PASAPQ Score for All Patients at Study End (Follow-up Assessment)', 'timeFrame': 'At follow-up assessment, 4 to 6 weeks after baseline.', 'description': 'The performance domain score of PASAPQ contained 7 items (Q 1-5 and 10-11), each item had response options ranging from 1 (very dissatisfied) to 7 (very satisfied). To calculate the domain score, the items were first summed and then transformed to a 0 (least) to 100 (most) point scale, with higher scores indicating greater satisfaction:\n\nPerformance score = 100 \\* \\[(Q1+ Q2+Q3+Q4+Q5+Q10+Q11)-7\\] / (49-7)'}, {'measure': 'Total Convenience PASAPQ Score for All Patients at Study End (Follow-up Assessment)', 'timeFrame': 'At follow-up assessment, 4 to 6 weeks after baseline.', 'description': 'The convenience domain score of PASAPQ contained 6 items (Question 6-9 and 12-13), each item had response options ranging from 1 (very dissatisfied) to 7 (very satisfied). To calculate the domain score, the items were first summed and then transformed to a 0 (least) to 100 (most) point scale, with higher scores indicating greater satisfaction:\n\nConvenience score = 100 \\* \\[(Q6+Q7+Q8+Q9+Q12+Q13)-6\\] / (42-6)'}, {'measure': 'Overall Satisfaction Question With Inhaler for All Patients at Study End (Follow-up Assessment)', 'timeFrame': 'At follow-up assessment, 4 to 6 weeks after baseline.', 'description': 'The overall satisfaction score of the PASAPQ asked for the overall satisfaction with the device used in the study (Question 14), answered using a 7-point scale ranging from 1 (very dissatisfied) to 7 (very satisfied). Reported is the number of patients by category.'}, {'measure': 'Question on Willingness to Continue With Inhaler for All Patients at Study End (Follow-up Assessment)', 'timeFrame': 'At follow-up assessment, 4 to 6 weeks after baseline.', 'description': 'To assess the willingness to continue with inhaler, the following questions was asked: "How would you feel about continuing to use the inhaler?", using a value from 0-100, with zero indicating that the patient is not willing to continue using the inhaler and 100 indicating that the patient is definitely willing to continue using the inhaler.'}, {'measure': 'Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)', 'timeFrame': 'At follow-up assessment, 4 to 6 weeks after baseline.', 'description': '10 Questions regarding the Ease of Handling were asked, using a 7 point scale ranging from 1 (very dissatisfied) to 7 (very satisfied). Reported is the number of patients by answer category.'}, {'measure': 'Difference in the Mean Total PASAPQ Score Between Study Entry and Study End in Respimat SMI-experienced Patients Who Switched From a Disposable to a Re-usable Respimat SMI Product', 'timeFrame': 'At study entry (baseline) and at study end (4 to 6 weeks after baseline).', 'description': 'Difference in the mean Total PASAPQ score between study entry (baseline visit) and at study end (follow-up assessment) in Respimat SMI-experienced patients who switched from a disposable to a re-usable Respimat SMI product at study entry.\n\nThe total score was the sum of the 13 items related to Performance and Convenience PASAPG domains (7 items for Performance domain: Q 1-5, 10-11, and 6 items for convenience domain: Q6-9, 12-13).\n\nEach PASAPQ item had response options ranging from 1 (very dissatisfied) to 7 (very satisfied). To calculate the total and domain score, the items within each domain were first summed and then transformed to a 0 (least) or 100 (most) point scale, with higher scores indicating greater satisfaction.'}, {'measure': 'Number of Patients With Preference for Re-usable or Disposable Respimat SMI at Study End in Respimat SMI-experienced Patients Who Switched From a Disposable to a Re-usable Respimat SMI Product', 'timeFrame': 'At follow-up assessment, 4 to 6 weeks after baseline.', 'description': 'Number of patients with preference for re-usable or disposable Respimat SMI at study end (follow-up assessment), in Respimat SMI-experienced patients who switched from a disposable to a re-usable Respimat SMI product at study entry. To assess the preference for inhaler, following question was asked: "Comparing the re-usable with disposable inhaler, which inhaler do you prefer to use?"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The study is to assess patient satisfaction with the inhaler attributes of the re-usable Respimat SMI (Spiriva, Striverdi or Spiolto) in patients with COPD, including patients who are Respimat SMI-experienced and Respimat SMI-naïve. This study also aims to examine patient preference for the re-usable Respimat SMI compared to the disposable Respimat SMI in Respimat SMI-experienced patients switching from a disposable to a re-usable Respimat SMI product at study entry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study is planned that approximately with 250 Chronic Obstructive Pulmonary Disease (COPD) patients (Respimat SMI-experienced and Respimat SMI-naïve) from Europe will be enrolled in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients fulfilling all the following inclusion criteria will be eligible for participation in the study:\n\n* Provision of signed informed consent prior to study data collection\n* Patient with COPD aged 40 years or older\n* Patient prescribed (or already receiving the disposable Respimat SMI and switched to) one of the following re-usable Respimat SMI products per the standard clinical practice: Spiriva 2.5 microgram inhalation solution; (2) Striverdi 2.5 microgram inhalation solution; and (3) Spiolto 2.5 microgram / 2.5 microgram inhalation solution\n* Patient unlikely to change their Respimat therapy during the 4-6 week observation period (in the opinion of the investigator)\n\nExclusion Criteria:\n\nPatients fulfilling any of the following exclusion criteria will not be eligible for participation in the study:\n\n* Patient using a disposable Respimat SMI product during the study period\n* Patient who have had a severe COPD exacerbation requiring hospitalisation in the immediate 3 months prior to study entry\n* Patient participating in a clinical trial or any other non-interventional study of a drug or device at the time of enrolment\n* Visual, cognitive, motor or health impairment that, as judged by the investigator, may cause concern regarding the patient's ability to complete the questionnaires\n* Patient not fluent and literate in one of the main languages of the country"}, 'identificationModule': {'nctId': 'NCT04011735', 'briefTitle': 'Re-usable Respimat® Soft MistTM Inhaler Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Real-world Non-interventional Study to Assess Patient Satisfaction With and Preference for Re-usable Respimat Soft Mist Inhaler in Patients With Chronic Obstructive Pulmonary Disease.', 'orgStudyIdInfo': {'id': '1237-0097'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Respimat SMI-experienced: Switching to re-usable Respimat', 'description': 'patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry.', 'interventionNames': ['Drug: Respimat']}, {'label': 'Respimat SMI-naïve', 'description': 'patients who have not previously used a Respimat SMI product and receive their first prescription at study entry', 'interventionNames': ['Drug: Respimat']}, {'label': 'Respimat SMI-experienced: Maintenance treatment', 'description': 'patients who have been on maintenance treatment with a Respimat SMI product and receive a refill prescription at study entry.'}], 'interventions': [{'name': 'Respimat', 'type': 'DRUG', 'otherNames': ['(Spiriva®, Striverdi® or', 'Spiolto®)'], 'description': 'Soft Mist Inhaler product', 'armGroupLabels': ['Respimat SMI-experienced: Switching to re-usable Respimat', 'Respimat SMI-naïve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Brussels - UNIV UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '6041', 'city': 'Gosselies', 'country': 'Belgium', 'facility': 'Clinique Notre-Dame de Grâce', 'geoPoint': {'lat': 50.46936, 'lon': 4.43324}}, {'zip': '8930', 'city': 'Menen', 'country': 'Belgium', 'facility': 'Roeselare - HOSP AZ Delta', 'geoPoint': {'lat': 50.79722, 'lon': 3.12245}}, {'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': '7100', 'city': 'Vejle', 'country': 'Denmark', 'facility': 'Vejle Hospital', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}, {'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'TYKS, Keuhkosairauksien klinikka, Turku', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Universitätsklinikum Aachen, AöR', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'MECS Research GmbH, Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '56068', 'city': 'Koblenz', 'country': 'Germany', 'facility': 'KPPK GmbH, Studienzentrum', 'geoPoint': {'lat': 50.35357, 'lon': 7.57883}}, {'zip': '04207', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Pneumologiezentrum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '23558', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Pneumologische Schwerpunktpraxis, 23558 Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '4818 CK', 'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia Ziekenhuis', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '6419 PC', 'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Zuyderland Medisch Centrum', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'zip': '8934 AD', 'city': 'Leeuwarden', 'country': 'Netherlands', 'facility': 'Medisch Centrum Leeuwarden', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'zip': '3045 PM', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Franciscus Gasthuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '7207 AE', 'city': 'Zutphen', 'country': 'Netherlands', 'facility': 'Gelre Ziekenhuis Zutphen', 'geoPoint': {'lat': 52.13833, 'lon': 6.20139}}, {'zip': 'N-2402', 'city': 'Elverum', 'country': 'Norway', 'facility': 'Frisk Utvikling Helse AS', 'geoPoint': {'lat': 60.88191, 'lon': 11.56231}}, {'zip': 'N-4816', 'city': 'Kolbjørnsvik', 'country': 'Norway', 'facility': 'Hisøy Legesenter', 'geoPoint': {'lat': 58.45306, 'lon': 8.77056}}, {'zip': 'N-1157', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Lambertseter Legesenter', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': 'N-3060', 'city': 'Svelvik', 'country': 'Norway', 'facility': 'Svelvik Legesenter', 'geoPoint': {'lat': 59.6137, 'lon': 10.40872}}]}, 'ipdSharingStatementModule': {'url': 'https://trials.boehringer-ingelheim.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.', 'ipdSharing': 'YES', 'description': 'After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://trials.boehringer-ingelheim.com/trial\\_results/ clinical\\_submission\\_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".\n\nAlso, Researchers can use the following link http://trials.boehringeringelheim.com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.\n\nThe data shared are the raw clinical study data sets.', 'accessCriteria': "For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}