Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)
NCT ID: NCT03954132
Last Updated: 2024-04-24
Study Results
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View full resultsBasic Information
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COMPLETED
469 participants
OBSERVATIONAL
2019-06-07
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Spiolto® Respimat®
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.
Spiolto® Respimat®
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.
Triple-Therapy (LAMA/LABA/ICS)
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.
Triple-Therapy (LAMA/LABA/ICS)
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.
Interventions
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Spiolto® Respimat®
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.
Triple-Therapy (LAMA/LABA/ICS)
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of COPD
* Symptomatic (with regard to dyspnea (mMRC Dyspnea score ≥1) AND with regard to symptoms (CAT Score ≥10) at the same time)
* 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.
* Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel
* Male or female
* Patients aged ≥40 years of age
* Written informed consent prior to study participation
* The patient is willing and able to follow the procedures outlined in the protocol
Exclusion Criteria
* 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)
* Lack of informed consent
* Pregnant and/or lactating females
* Acute exacerbation of COPD (within 4 weeks prior to Visit 1)
* 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
* Acute respiratory failure (pH \<7,35 and/ or respiratory rate \>30/min within 3 months prior to Visit 1)
* History or current diagnosis of asthma
* History or current diagnosis of asthma-COPD overlap
* History or current diagnosis of allergic rhinitis within the last 5 years
* History or current diagnosis of lung cancer within the last 5 years
* Participation in a parallel interventional clinical trial
* mild exacerbation: additional use of short-acting bronchodilators and treated by the patient without consulting a physician
* moderate exacerbation: treatment includes medical prescription of a systemic corticosteroid and/or antibiotic
* severe exacerbation: exacerbation leading to hospitalization
40 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Dr. Graubner
Bad Sachsa, , Germany
Dr. Junggeburth
Bad Wörishofen, , Germany
Dr. Heinz
Bergisch Gladbach, , Germany
Praxis E. Hossbach
Berkatal, , Germany
Praxis an der Oper
Berlin, , Germany
Dr. Urban
Berlin, , Germany
Praxis A.Sahan/S. Erbil-Sahan
Berlin, , Germany
Dr. Kopf
Berlin, , Germany
Dres. Pabst/Schlünz
Bonn, , Germany
Dr. Schwittay
Böhlen B Leipzig, , Germany
Dres. Bartels/Bartels
Breuberg, , Germany
Dr. Grimm-Sachs
Bruchsal, , Germany
Praxis B. Metzlaff
Büchen, , Germany
Ambulantes Zentrum
Cottbus, , Germany
Lungenzentrum Darmstadt
Darmstadt, , Germany
Hausarzt Deggingen
Deggingen, , Germany
Dres. Tietjens
Dortmund, , Germany
Dr. Schwiese
Duisburg, , Germany
Schwerpunktpraxis
Düsseldorf, , Germany
Dr. Schmorell
Forchheim, Oberfr, , Germany
Praxis A. Xanthopoulos
Fürstenwalde, , Germany
Dr. Sommer
Garmisch-Partenkirchen, , Germany
Dres. Ern/Trilling
Gelsenkirchen, , Germany
Dr. Birkner
Gelsenkirchen, , Germany
Praxis C. Staack/Z. Zadrozny
Gelsenkirchen, , Germany
Das HausarztZentrum
Grafenrheinfeld, , Germany
Dres. Coesfeld/Gams/Gams
Gütersloh, , Germany
Pneumologicum Halle
Halle, , Germany
MVZ Martha-Maria gGmbH
Halle, , Germany
Dr. Knolinski
Hamburg, , Germany
Dres. Kaase/Lepinat
Hamburg, , Germany
Dr. Abenhardt
Heidelberg, Neckar, , Germany
Dr. Koch
Heilbad Heiligenstadt, , Germany
Dres Stolpe/ Roß
Ibbenbueren, , Germany
Dres. Lehmann/Schulze und Partner
Jerichow, , Germany
Dr. Beckmann
Kamen, Westf, , Germany
Praxis G. Mohanty
Kamp-Lintfort, , Germany
Dr. Auge
Koblenz Am Rhein, , Germany
Dres. Lehmann/Schulze und Partner
Köthen, , Germany
Dr. Pfitzer
Kronach, Oberfr, , Germany
Dres. Alshut/Weberling
Lahnau, , Germany
Dr. Einenkel
Leipzig, , Germany
Dr. Geßner
Leipzig, , Germany
Dr. Pitule
Ludwigshafen am Rhein, , Germany
Dr. Hladik
Ludwigshafen am Rhein, , Germany
Dr. Saur
Mannheim, , Germany
Dres. Jerrentrup/Mronga
Marburg, , Germany
Dr. Jansen
Menden (Sauerland), , Germany
Dr. Ingerl
Mosbach, Baden, , Germany
Dr. Feimer
München, , Germany
Thoraxzentrum Bez. Unterfranken
Münnerstadt, , Germany
Praxis Th. Hagen
Neumarkt in der Oberpfalz, , Germany
Praxis W. Wuttke
Nuremberg, , Germany
Dr. Laser
Nürnberg, Mittelfr, , Germany
MVZ OB-Sterkrade GmbH
Oberhausen, Rheinl, , Germany
Dr. Müller
Potsdam, , Germany
Dres. Hennig/Mikes
Radebeul, , Germany
Dr. Dinh
Rathenow, , Germany
Zentrum für Onkologie
Rostock, , Germany
Lungenfachzentrum Rhein-Main
Rüsselsheim am Main, , Germany
Lungenzentrum Schleswig
Schleswig, , Germany
Dres. Korupp/Rose
Schweinfurt, , Germany
Dr. Theuer
Seelow, , Germany
Praxis S. Schmidt
Siegen, , Germany
Dres. Knöbel und Partner
Straubing, , Germany
Dr. Rother
Strausberg, , Germany
Marienhospital Stuttgart
Stuttgart, , Germany
Dr. Schmidt-Reinwald
Trier, , Germany
Lungenzentrum Ulm
Ulm, Donau, , Germany
Dres. Günther/Günther
Viernheim, , Germany
Dres. Waltert/Esselmann
Warendorf, , Germany
Dres. Herold/Kaa
Weißenburg I Bay, , Germany
Dres. Fried/Rubin
Wiesbaden, , Germany
Dr. Franz
Witten, , Germany
Dr. Weber
Witten, , Germany
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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1237-0087
Identifier Type: -
Identifier Source: org_study_id
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