Condition or disease | Intervention/treatment |
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Pulmonary Disease, Chronic Obstructive | Drug: Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist Drug: Triple combination of Free or fixed Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist + inhalative corticosteroids |
Study Type : | Observational |
Estimated Enrollment : | 600 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | 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 |
Actual Study Start Date : | June 7, 2019 |
Estimated Primary Completion Date : | June 30, 2021 |
Estimated Study Completion Date : | September 30, 2021 |
Group/Cohort | Intervention/treatment |
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Subject with Chronic Obstructive pulmonary disease |
Drug: Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist
LAMA+LABA
Other Name: Spiolto® Respimat®
Drug: Triple combination of Free or fixed Long-acting muscarinic antagonist+ Long-acting beta2 adrenoceptor agonist + inhalative corticosteroids (LAMA+LABA+ Inhalative Corticosteroids (ICS)
Other Name: LAMA+LABA+ Inhalative Corticosteroids (ICS)
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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Patients can be included if all of the following criteria are met:
Exclusion Criteria:
Contact: Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Study Chair: | Andrea Marseille, 0049613277141881 | andrea.marseille@boehringer-ingelheim.com |
Tracking Information | |||||||||||||||||
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First Submitted Date | May 15, 2019 | ||||||||||||||||
First Posted Date | May 17, 2019 | ||||||||||||||||
Last Update Posted Date | May 19, 2021 | ||||||||||||||||
Actual Study Start Date | June 7, 2019 | ||||||||||||||||
Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||||||||||
Change History | |||||||||||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title | Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®) | ||||||||||||||||
Official Title | 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 | ||||||||||||||||
Brief Summary | Open-label comparative multicentric cohort study in COPD patients with LABA/ICS, switched to either tiotropium/olodaterol and observed for 12 weeks approximately. | ||||||||||||||||
Detailed Description | 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. | ||||||||||||||||
Study Type | Observational | ||||||||||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||||||||||
Biospecimen | Not Provided | ||||||||||||||||
Sampling Method | Non-Probability Sample | ||||||||||||||||
Study Population | Study is based on newly collected data from approximately 900 COPD patients from 150 recruiting sites in Germany. | ||||||||||||||||
Condition | Pulmonary Disease, Chronic Obstructive | ||||||||||||||||
Intervention |
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Study Groups/Cohorts | Subject with Chronic Obstructive pulmonary disease
Interventions:
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Publications * | 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(®) Study Protocol. Int J Chron Obstruct Pulmon Dis. 2020 Oct 22;15:2601-2608. doi: 10.2147/COPD.S262746. eCollection 2020. | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status | Recruiting | ||||||||||||||||
Estimated Enrollment |
600 | ||||||||||||||||
Original Estimated Enrollment |
900 | ||||||||||||||||
Estimated Study Completion Date | September 30, 2021 | ||||||||||||||||
Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria |
Inclusion Criteria: Patients can be included if all of the following criteria are met:
Exclusion Criteria:
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Sex/Gender |
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Ages | 40 Years and older (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||
Contacts |
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Listed Location Countries | Germany | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number | NCT03954132 | ||||||||||||||||
Other Study ID Numbers | 1237-0087 | ||||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Boehringer Ingelheim | ||||||||||||||||
Study Sponsor | Boehringer Ingelheim | ||||||||||||||||
Collaborators | Not Provided | ||||||||||||||||
Investigators |
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PRS Account | Boehringer Ingelheim | ||||||||||||||||
Verification Date | May 2021 |