Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
Study NCT ID:
NCT03954132
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2019-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)
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', 'phoneExt': '001', '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}, 'limitationsAndCaveats': {'description': 'There are some limitations due to the observational, non-randomized study concept. Imbalances between treatment groups could be due to the observational, non-randomized study design reflecting real-world data.\n\nLess patients than originally planned have been included (900 patients planned vs. 469 patients actual). Patient inclusion was impaired by the Corona pandemic from early spring 2020 on.'}}, 'adverseEventsModule': {'timeFrame': 'The study design is of non-interventional nature and the study is conducted within the conditions of the approved marketing authorization. Sufficient data from controlled interventional trials are available to support the evidence on the safety and efficacy of the studied BI drug. Collected were: - all adverse drug reaction (ADRs) (serious and non-serious), - all adverse events with fatal outcome', 'description': 'From the beginning of treatment till the end of the study, up to 42 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Spiolto® Respimat®', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting.', 'otherNumAtRisk': 329, 'deathsNumAtRisk': 329, 'otherNumAffected': 0, 'seriousNumAtRisk': 329, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Triple-Therapy (LAMA/LABA/ICS)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting.', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 134, 'otherNumAffected': 0, 'seriousNumAtRisk': 134, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Modified Medical Research Council (mMRC) Score Between Baseline and After End of Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting. Patients were propensity score matched to the Triple-Therapy arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.'}, {'id': 'OG001', 'title': 'Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting. Patients were propensity score matched to the Spiolto® Respimat® arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '0.11', 'upperLimit': '0.36'}, {'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '0.13', 'upperLimit': '0.38'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).', 'description': 'Change in mMRC (modified Medical Research Council) score between baseline and after end of observation (ca. 12 weeks of treatment, Visit 2). The modified Medical Research Council (mMRC) scale is a 5-point (0-4) scale based on the severity of dyspnoea, where a 0 is the best possible score with no disability and 4 is the worst possible score representing the most severity. The mMRC will be used to assess the breathlessness state of the patient with just one question: "When do you experience dyspnoea?", covering five everyday activities, potentially leading to dyspnoea and giving an according rate of 0 to 4 points. The Minimum Clinically Important Difference (MCID) is a change of 1.0 point. Change calculated as Visit 1 - Visit 2.', 'unitOfMeasure': 'Change in score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched set (MS): All patients with informed consent who met all inclusion criteria as well as no exclusion criteria and have received at least one dose of Spiolto® Respimat® or triple combination (free or fixed LAMA + LABA+ ICS), excluding all patients who could not be matched in the propensity score matching, patients with missing data for this outcome measure were not replaced or imputed.'}, {'type': 'PRIMARY', 'title': 'Change in CATᵀᴹ (COPD Assessment Test) Score Between Baseline and After End of Observation (ca. 12 Weeks of Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting. Patients were propensity score matched to the Triple-Therapy arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.'}, {'id': 'OG001', 'title': 'Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting. Patients were propensity score matched to the Spiolto® Respimat® arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.45', 'groupId': 'OG000', 'lowerLimit': '2.45', 'upperLimit': '4.45'}, {'value': '2.51', 'groupId': 'OG001', 'lowerLimit': '1.62', 'upperLimit': '3.40'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).', 'description': 'The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CATᵀᴹ) was developed as a simple instrument to assess health status in patients with COPD. The CATᵀᴹ consists of eight items, each formatted as a semantic six-point differential scale, making the tool easy to administer and easy for patients to complete. These eight items cover cough, phlegm, chest tightness, breathlessness when going up hills/stairs, activity limitations at home, confidence leaving home, sleep and energy. Each item is scored from 0 to 5. Total CAT score is calculated as the sum over the 8 items, resulting in a total score ranging from 0 to 40, corresponding to the best and worst health status in patients with COPD, respectively. The Minimum Clinically Important Difference (MCID) is a change of 2.0 points. Change is calculated as Visit 1 - Visit 2.', 'unitOfMeasure': 'Change in score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched set (MS): All patients with informed consent who met all inclusion criteria as well as no exclusion criteria and have received at least one dose of Spiolto® Respimat® or triple combination (free or fixed LAMA + LABA+ ICS), excluding all patients who could not be matched in the propensity score matching, patients with missing data for this outcome measure were not replaced or imputed.'}, {'type': 'SECONDARY', 'title': "Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting. Patients were propensity score matched to the Triple-Therapy arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.'}, {'id': 'OG001', 'title': 'Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting. Patients were propensity score matched to the Spiolto® Respimat® arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.'}], 'classes': [{'categories': [{'title': 'PGE score 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'PGE score 2', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'PGE score 3', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'PGE score 4', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}, {'title': 'PGE score 5', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'PGE score 6', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'PGE score 7', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'PGE score 8', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline at Visit 1 (day 0)', 'description': "The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1-2 (poor), 3-4 (satisfactory), 5-6 (good) to 7-8 (excellent).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched set (MS): All patients with informed consent who met all inclusion criteria as well as no exclusion criteria and have received at least one dose of Spiolto® Respimat® or triple combination (free or fixed LAMA + LABA+ ICS), excluding all patients who could not be matched in the propensity score matching, patients with missing data for this outcome measure were not replaced or imputed.'}, {'type': 'SECONDARY', 'title': "Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period", 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting. Patients were propensity score matched to the Triple-Therapy arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.'}, {'id': 'OG001', 'title': 'Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting. Patients were propensity score matched to the Spiolto® Respimat® arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.'}], 'classes': [{'categories': [{'title': 'PGE score 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'PGE score 2', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'PGE score 3', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'PGE score 4', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'PGE score 5', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'title': 'PGE score 6', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'PGE score 7', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'PGE score 8', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 2 (planned at 12 week, up to a maximum of 42 weeks)', 'description': "The treating physician will use the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched set (MS): All patients with informed consent who met all inclusion criteria as well as no exclusion criteria and have received at least one dose of Spiolto® Respimat® or triple combination (free or fixed LAMA + LABA+ ICS), excluding all patients who could not be matched in the propensity score matching, patients with missing data for this outcome measure were not replaced or imputed.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Inhaler and Therapy at End of Observation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting. Patients were propensity score matched to the Triple-Therapy arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.'}, {'id': 'OG001', 'title': 'Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting. Patients were propensity score matched to the Spiolto® Respimat® arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.'}], 'classes': [{'title': 'Patient overall satisfaction with treatment', 'categories': [{'title': 'Very satisfied', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Satisfied', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Rather satisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Rather dissatisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Very dissatisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Patient satisfaction with handling of the inhalation device', 'categories': [{'title': 'Very satisfied', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Satisfied', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'Rather satisfied', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Rather dissatisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Very dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Patient satisfaction with inhaling from the device', 'categories': [{'title': 'Very satisfied', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Satisfied', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': 'Rather satisfied', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Rather dissatisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Very dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Patient satisfaction with the device in general', 'categories': [{'title': 'Very satisfied', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Satisfied', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'Rather satisfied', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Rather dissatisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Very dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 2 (planned at 12 week, up to a maximum of 42 weeks).', 'description': 'Patient satisfaction with inhaler and therapy at end of observation period according to a seven-point ordinal scale (ranging from very dissatisfied to very satisfied).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched set (MS): All patients with informed consent who met all inclusion criteria as well as no exclusion criteria and have received at least one dose of Spiolto® Respimat® or triple combination (free or fixed LAMA + LABA+ ICS), excluding all patients who could not be matched in the propensity score matching, patients with missing data for this outcome measure were not replaced or imputed.'}, {'type': 'SECONDARY', 'title': 'Number of Responders With Δ mMRC≥ 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting. Patients were propensity score matched to the Triple-Therapy arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.'}, {'id': 'OG001', 'title': 'Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting. Patients were propensity score matched to the Spiolto® Respimat® arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.'}], 'classes': [{'categories': [{'title': 'Δ mMRC<1', 'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}, {'title': 'Δ mMRC≥1', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'Not available', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).', 'description': 'Number of responders with a change in modified Medical Research Council (mMRC) greater than or equal to 1 between visit 1 and 2. The mMRC was used to assess the severity of the breathlessness. the mMRC consists of five statements describing the patients grade of breathlessness ranging from 0 (best outcome) to 4 (worst outcome).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched set (MS): All patients with informed consent who met all inclusion criteria as well as no exclusion criteria and have received at least one dose of Spiolto® Respimat® or triple combination (free or fixed LAMA + LABA+ ICS), excluding all patients who could not be matched in the propensity score matching, patients with missing data for this outcome measure were not replaced or imputed.'}, {'type': 'SECONDARY', 'title': 'Number of Responders With Δ CAT≥ 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting. Patients were propensity score matched to the Triple-Therapy arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.'}, {'id': 'OG001', 'title': 'Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting. Patients were propensity score matched to the Spiolto® Respimat® arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.'}], 'classes': [{'categories': [{'title': 'Δ CAT<2', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'title': 'Δ CAT≥2', 'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}, {'title': 'Not available', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).', 'description': 'Number of responders with a change in the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) greater than or equal to 2 between visit 1 and 2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched set (MS): All patients with informed consent who met all inclusion criteria as well as no exclusion criteria and have received at least one dose of Spiolto® Respimat® or triple combination (free or fixed LAMA + LABA+ ICS), excluding all patients who could not be matched in the propensity score matching, patients with missing data for this outcome measure were not replaced or imputed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Spiolto® Respimat®', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting.'}, {'id': 'FG001', 'title': 'Triple-Therapy (LAMA/LABA/ICS)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Patients with Visit 1 and treated (=Treated Set)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '329'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'Per Protocol Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '129'}]}, {'type': 'Treated Subjects With Protocol Violations', 'comment': 'Treated patients with protocol violations, patients were excluded from the per protocol set.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Treated Subjects Excluded From Per Protocol Set', 'comment': 'Patient excluded from per protocol set due to open query related to in-/exclusion criteria.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Patients with Visit 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '303'}, {'groupId': 'FG001', 'numSubjects': '129'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': "Patient's wish", 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Screening failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'No registration after Visit 1', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other reason than listed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Patient could not make visit due to vertebral fracture', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'False inclusion, violation of exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was an open-label comparative multicentric cohort non interventional study based on newly collected data. Chronic Obstructive Pulmonary Disease (COPD) patients receiving a Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids treatment until visit 1 were switched at the discretion of the attending physician to either tiotropium/olodaterol in the new reusable Respimat® inhaler or any triple therapy according to clinical routine. Observational period was approximately 12 weeks.', 'preAssignmentDetails': 'All patients were screened for eligibility prior to participation in the trial. 6 patients were not recruited and treated. 24 patients in the treated set had at least one violations of the in- and/or exclusion criteria and were not included in the per protocol set (and the derived matched set).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '463', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Spiolto® Respimat®', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting.'}, {'id': 'BG001', 'title': 'Triple-Therapy (LAMA/LABA/ICS)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '463', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66.5', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '69.2', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '67.3', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '463', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'modified Medical Research Council (mMRC) score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.07', 'spread': '0.80', 'groupId': 'BG000'}, {'value': '2.07', 'spread': '0.81', 'groupId': 'BG001'}, {'value': '2.07', 'spread': '0.80', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The modified Medical Research Council (mMRC) scale is a 5-point (0-4) scale based on the severity of dyspnoea, where a 0 is the best possible score with no disability and 4 is the worst possible score representing the most severity. The mMRC will be used to assess the breathlessness state of the patient with just one question: "When do you experience dyspnoea?", covering five everyday activities, potentially leading to dyspnoea and giving an according rate of 0 to 4 points.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Matched set (MS): All patients with informed consent who met all inclusion criteria as well as no exclusion criteria and have received at least one dose of Spiolto® Respimat® or triple combination (free or fixed LAMA + LABA+ ICS), excluding all patients who could not be matched in the propensity score matching, patients with missing data were not replaced or imputed.'}, {'title': 'CATᵀᴹ (COPD assessment test) score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21.72', 'spread': '6.29', 'groupId': 'BG000'}, {'value': '21.79', 'spread': '6.72', 'groupId': 'BG001'}, {'value': '21.76', 'spread': '6.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CATᵀᴹ). The CATᵀᴹ consists of eight items, each formatted as a semantic six-point differential scale. These eight items cover cough, phlegm, chest tightness, breathlessness when going up hills/stairs, activity limitations at home, confidence leaving home, sleep and energy. Each item is scored from 0 to 5. Total CAT score is calculated as the sum over the 8 items, resulting in a total score ranging from 0 to 40, corresponding to the best and worst health status in patients with COPD, respectively.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Matched set (MS): All patients with informed consent who met all inclusion criteria as well as no exclusion criteria and have received at least one dose of Spiolto® Respimat® or triple combination (free or fixed LAMA + LABA+ ICS), excluding all patients who could not be matched in the propensity score matching, patients with missing data were not replaced or imputed.'}], 'populationDescription': 'Treated set (TS): All patients with informed consent who have received at least one dose of Spiolto® Respimat® or triple combination (free or fixed LAMA + LABA+ ICS).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-07', 'size': 1148095, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-26T03:11', 'hasProtocol': True}, {'date': '2020-08-11', 'size': 400567, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-08-26T03:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 469}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2019-05-15', 'resultsFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2019-05-15', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-05', 'studyFirstPostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Modified Medical Research Council (mMRC) Score Between Baseline and After End of Observation', 'timeFrame': 'Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).', 'description': 'Change in mMRC (modified Medical Research Council) score between baseline and after end of observation (ca. 12 weeks of treatment, Visit 2). The modified Medical Research Council (mMRC) scale is a 5-point (0-4) scale based on the severity of dyspnoea, where a 0 is the best possible score with no disability and 4 is the worst possible score representing the most severity. The mMRC will be used to assess the breathlessness state of the patient with just one question: "When do you experience dyspnoea?", covering five everyday activities, potentially leading to dyspnoea and giving an according rate of 0 to 4 points. The Minimum Clinically Important Difference (MCID) is a change of 1.0 point. Change calculated as Visit 1 - Visit 2.'}, {'measure': 'Change in CATᵀᴹ (COPD Assessment Test) Score Between Baseline and After End of Observation (ca. 12 Weeks of Treatment)', 'timeFrame': 'Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).', 'description': 'The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CATᵀᴹ) was developed as a simple instrument to assess health status in patients with COPD. The CATᵀᴹ consists of eight items, each formatted as a semantic six-point differential scale, making the tool easy to administer and easy for patients to complete. These eight items cover cough, phlegm, chest tightness, breathlessness when going up hills/stairs, activity limitations at home, confidence leaving home, sleep and energy. Each item is scored from 0 to 5. Total CAT score is calculated as the sum over the 8 items, resulting in a total score ranging from 0 to 40, corresponding to the best and worst health status in patients with COPD, respectively. The Minimum Clinically Important Difference (MCID) is a change of 2.0 points. Change is calculated as Visit 1 - Visit 2.'}], 'secondaryOutcomes': [{'measure': "Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline", 'timeFrame': 'Baseline at Visit 1 (day 0)', 'description': "The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1-2 (poor), 3-4 (satisfactory), 5-6 (good) to 7-8 (excellent)."}, {'measure': "Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period", 'timeFrame': 'Visit 2 (planned at 12 week, up to a maximum of 42 weeks)', 'description': "The treating physician will use the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent)."}, {'measure': 'Patient Satisfaction With Inhaler and Therapy at End of Observation Period', 'timeFrame': 'Visit 2 (planned at 12 week, up to a maximum of 42 weeks).', 'description': 'Patient satisfaction with inhaler and therapy at end of observation period according to a seven-point ordinal scale (ranging from very dissatisfied to very satisfied).'}, {'measure': 'Number of Responders With Δ mMRC≥ 1', 'timeFrame': 'Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).', 'description': 'Number of responders with a change in modified Medical Research Council (mMRC) greater than or equal to 1 between visit 1 and 2. The mMRC was used to assess the severity of the breathlessness. the mMRC consists of five statements describing the patients grade of breathlessness ranging from 0 (best outcome) to 4 (worst outcome).'}, {'measure': 'Number of Responders With Δ CAT≥ 2', 'timeFrame': 'Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).', 'description': 'Number of responders with a change in the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) greater than or equal to 2 between visit 1 and 2.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '37256536', 'type': 'DERIVED', 'citation': 'Buhl R, Dreher M, Mattiucci-Guehlke M, Emerson-Stadler R, Eckhardt S, Taube C, Vogelmeier CF. EVELUT(R): A Real-World, Observational Study Assessing Dyspnoea and Symptom Burden in COPD Patients Switched from LABA/ICS to LAMA/LABA or LAMA/LABA/ICS. Adv Ther. 2023 Jul;40(7):3263-3278. doi: 10.1007/s12325-023-02524-y. Epub 2023 May 31.'}, {'pmid': '33122898', 'type': 'DERIVED', 'citation': 'Buhl R, Dreher M, Korn S, Taube C, Stock C, Zehendner CM, Kondla A, Vogelmeier CF. A Non-Interventional Study of Tiotropium/Olodaterol versus Any Triple Combination Therapy for Chronic Obstructive Pulmonary Disease: The EVELUT(R) Study Protocol. Int J Chron Obstruct Pulmon Dis. 2020 Oct 22;15:2601-2608. doi: 10.2147/COPD.S262746. eCollection 2020.'}], 'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Open-label comparative multicentric cohort study in COPD patients with LABA/ICS, switched to either tiotropium/olodaterol and observed for 12 weeks approximately.', 'detailedDescription': 'COPD patients on LABA/ICS maintenance therapy with dyspnea (mMRC ≥ 1) and other symptoms (CATTM ≥ 10), who are switched to either Spiolto® Respimat® in the new reusable inhaler or any triple therapy (LAMA + LABA + ICS) as an open or fixed combination according to approved SmPCs at baseline at the discretion of their attending physician.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study is based on newly collected data from approximately 900 COPD patients from 150 recruiting sites in Germany.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients can be included if all of the following criteria are met:\n\n* Diagnosis of COPD\n* Symptomatic (with regard to dyspnea (mMRC Dyspnea score ≥1) AND with regard to symptoms (CAT Score ≥10) at the same time)\n* Patients on LABA/ICS maintenance therapy who are switched to Spiolto® Respimat® in the new reusable inhaler or a free/fixed triple combination of LABA + LAMA + ICS at Visit 1 at the discretion of the treating physician.\n* Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel\n* Male or female\n* Patients aged ≥40 years of age\n* Written informed consent prior to study participation\n* The patient is willing and able to follow the procedures outlined in the protocol\n\nExclusion Criteria:\n\n* Patients with contraindications acc. to SmPC\n* Patients not on LABA/ICS maintenance treatment at visit 1, e.g., mono or dual bronchodilation only, ICS only, or a triple combination of LAMA + LABA + ICS (either as a fixed combination product or as separate components)\n* Lack of informed consent\n* Pregnant and/or lactating females\n* Acute exacerbation of COPD (within 4 weeks prior to Visit 1)\n* Frequently exacerbating patients, i. e. patients with ≥2 moderate exacerbations within the last 12 months or ≥1 exacerbation leading to hospitalization within the last 12 months\n* Acute respiratory failure (pH \\<7,35 and/ or respiratory rate \\>30/min within 3 months prior to Visit 1)\n* History or current diagnosis of asthma\n* History or current diagnosis of asthma-COPD overlap\n* History or current diagnosis of allergic rhinitis within the last 5 years\n* History or current diagnosis of lung cancer within the last 5 years\n* Participation in a parallel interventional clinical trial\n* mild exacerbation: additional use of short-acting bronchodilators and treated by the patient without consulting a physician\n* moderate exacerbation: treatment includes medical prescription of a systemic corticosteroid and/or antibiotic\n* severe exacerbation: exacerbation leading to hospitalization'}, 'identificationModule': {'nctId': 'NCT03954132', 'briefTitle': 'Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'EVELUT®: Assessment of Dyspnea and Other Symptoms as Patient Reported Outcomes (PRO) in Patients With Chronic Obstructive Pulmonary Disease (COPD), Symptomatic on LABA/ICS Maintenance Therapy (Now) Treated With Spiolto® Respimat® (Tiotropium/Olodaterol) in Comparison to Open or Fixed Triple Combination Treatment in Routine Clinical Practice', 'orgStudyIdInfo': {'id': '1237-0087'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spiolto® Respimat®', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting.', 'interventionNames': ['Drug: Spiolto® Respimat®']}, {'label': 'Triple-Therapy (LAMA/LABA/ICS)', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting.', 'interventionNames': ['Drug: Triple-Therapy (LAMA/LABA/ICS)']}], 'interventions': [{'name': 'Spiolto® Respimat®', 'type': 'DRUG', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting.', 'armGroupLabels': ['Spiolto® Respimat®']}, {'name': 'Triple-Therapy (LAMA/LABA/ICS)', 'type': 'DRUG', 'description': 'Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting.', 'armGroupLabels': ['Triple-Therapy (LAMA/LABA/ICS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37441', 'city': 'Bad Sachsa', 'country': 'Germany', 'facility': 'Dr. Graubner', 'geoPoint': {'lat': 51.59499, 'lon': 10.55546}}, {'zip': '86825', 'city': 'Bad Wörishofen', 'country': 'Germany', 'facility': 'Dr. Junggeburth', 'geoPoint': {'lat': 48.00674, 'lon': 10.59666}}, {'zip': '51429', 'city': 'Bergisch Gladbach', 'country': 'Germany', 'facility': 'Dr. Heinz', 'geoPoint': {'lat': 50.9856, 'lon': 7.13298}}, {'zip': '37297', 'city': 'Berkatal', 'country': 'Germany', 'facility': 'Praxis E. Hossbach'}, {'zip': '10625', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis an der Oper', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10711', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Dr. Urban', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12049', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis A.Sahan/S. Erbil-Sahan', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12459', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Dr. Kopf', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53123', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Dres. Pabst/Schlünz', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '04564', 'city': 'Böhlen B Leipzig', 'country': 'Germany', 'facility': 'Dr. Schwittay'}, {'zip': '64747', 'city': 'Breuberg', 'country': 'Germany', 'facility': 'Dres. 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Waltert/Esselmann', 'geoPoint': {'lat': 51.95109, 'lon': 7.98756}}, {'zip': '91781', 'city': 'Weißenburg I Bay', 'country': 'Germany', 'facility': 'Dres. Herold/Kaa'}, {'zip': '65183', 'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Dres. Fried/Rubin', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'zip': '58452', 'city': 'Witten', 'country': 'Germany', 'facility': 'Dr. Franz', 'geoPoint': {'lat': 51.44362, 'lon': 7.35258}}, {'zip': '58452', 'city': 'Witten', 'country': 'Germany', 'facility': 'Dr. Weber', 'geoPoint': {'lat': 51.44362, 'lon': 7.35258}}], 'overallOfficials': [{'name': 'Andrea Marseille, 0049613277141881', 'role': 'STUDY_CHAIR', 'affiliation': 'andrea.marseille@boehringer-ingelheim.com'}]}, 'ipdSharingStatementModule': {'url': 'https://www.mystudywindow.com/msw/datasharing', '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://www.mystudywindow.com/msw/datasharing 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 https://www.mystudywindow.com/msw/datasharing 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'}}}}