| Condition or disease | Intervention/treatment |
|---|---|
| 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 |
|---|---|
| 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)
|
| 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 |
Show 76 study locations
| Study Chair: | Andrea Marseille, 0049613277141881 | andrea.marseille@boehringer-ingelheim.com |
| Tracking Information | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ||||||||||||||||
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* 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 | ||||||||||||||||