Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)
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
1 other identifier
observational
469
1 country
75
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Typical duration for all trials
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2019
CompletedFirst Posted
Study publicly available on registry
May 17, 2019
CompletedStudy Start
First participant enrolled
June 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedResults Posted
Study results publicly available
March 15, 2024
CompletedApril 24, 2024
April 1, 2024
2.1 years
May 15, 2019
September 26, 2022
April 18, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Modified Medical Research Council (mMRC) Score Between Baseline and After End of Observation
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.
Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).
Change in CATᵀᴹ (COPD Assessment Test) Score Between Baseline and After End of Observation (ca. 12 Weeks of Treatment)
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.
Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).
Secondary Outcomes (5)
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline
Baseline at Visit 1 (day 0)
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period
Visit 2 (planned at 12 week, up to a maximum of 42 weeks)
Patient Satisfaction With Inhaler and Therapy at End of Observation Period
Visit 2 (planned at 12 week, up to a maximum of 42 weeks).
Number of Responders With Δ mMRC≥ 1
Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).
Number of Responders With Δ CAT≥ 2
Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).
Study Arms (2)
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.
Interventions
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.
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
Study is based on newly collected data from approximately 900 COPD patients from 150 recruiting sites in Germany.
You may qualify if:
- Patients can be included if all of the following criteria are met:
- 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
You may not qualify if:
- Patients with contraindications acc. to SmPC
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (75)
Dr. Graubner
Bad Sachsa, 37441, Germany
Dr. Junggeburth
Bad Wörishofen, 86825, Germany
Dr. Heinz
Bergisch Gladbach, 51429, Germany
Praxis E. Hossbach
Berkatal, 37297, Germany
Praxis an der Oper
Berlin, 10625, Germany
Dr. Urban
Berlin, 10711, Germany
Praxis A.Sahan/S. Erbil-Sahan
Berlin, 12049, Germany
Dr. Kopf
Berlin, 12459, Germany
Dres. Pabst/Schlünz
Bonn, 53123, Germany
Dr. Schwittay
Böhlen B Leipzig, 04564, Germany
Dres. Bartels/Bartels
Breuberg, 64747, Germany
Dr. Grimm-Sachs
Bruchsal, 76646, Germany
Praxis B. Metzlaff
Büchen, 21514, Germany
Ambulantes Zentrum
Cottbus, 03050, Germany
Lungenzentrum Darmstadt
Darmstadt, 64283, Germany
Hausarzt Deggingen
Deggingen, 73326, Germany
Dres. Tietjens
Dortmund, 44135, Germany
Dr. Schwiese
Duisburg, 47051, Germany
Schwerpunktpraxis
Düsseldorf, 40217, Germany
Dr. Schmorell
Forchheim, Oberfr, 91301, Germany
Praxis A. Xanthopoulos
Fürstenwalde, 15517, Germany
Dr. Sommer
Garmisch-Partenkirchen, 82467, Germany
Dres. Ern/Trilling
Gelsenkirchen, 45879, Germany
Dr. Birkner
Gelsenkirchen, 45881, Germany
Praxis C. Staack/Z. Zadrozny
Gelsenkirchen, 45891, Germany
Das HausarztZentrum
Grafenrheinfeld, 97506, Germany
Dres. Coesfeld/Gams/Gams
Gütersloh, 33330, Germany
Pneumologicum Halle
Halle, 06108, Germany
MVZ Martha-Maria gGmbH
Halle, 06110, Germany
Dr. Knolinski
Hamburg, 22459, Germany
Dres. Kaase/Lepinat
Hamburg, 22529, Germany
Dr. Abenhardt
Heidelberg, Neckar, 69115, Germany
Dr. Koch
Heilbad Heiligenstadt, 37308, Germany
Dres Stolpe/ Roß
Ibbenbueren, 49477, Germany
Dres. Lehmann/Schulze und Partner
Jerichow, 39319, Germany
Dr. Beckmann
Kamen, Westf, 59174, Germany
Praxis G. Mohanty
Kamp-Lintfort, 47475, Germany
Dr. Auge
Koblenz Am Rhein, 56068, Germany
Dres. Lehmann/Schulze und Partner
Köthen, 06366, Germany
Dr. Pfitzer
Kronach, Oberfr, 96317, Germany
Dres. Alshut/Weberling
Lahnau, 35633, Germany
Dr. Einenkel
Leipzig, 04109, Germany
Dr. Geßner
Leipzig, 04357, Germany
Dr. Pitule
Ludwigshafen am Rhein, 67061, Germany
Dr. Hladik
Ludwigshafen am Rhein, 67063, Germany
Dr. Saur
Mannheim, 68161, Germany
Dres. Jerrentrup/Mronga
Marburg, 35037, Germany
Dr. Jansen
Menden (Sauerland), 58706, Germany
Dr. Ingerl
Mosbach, Baden, 74821, Germany
Dr. Feimer
München, 80539, Germany
Thoraxzentrum Bez. Unterfranken
Münnerstadt, 97702, Germany
Praxis Th. Hagen
Neumarkt in der Oberpfalz, 92318, Germany
Praxis W. Wuttke
Nuremberg, 90478, Germany
Dr. Laser
Nürnberg, Mittelfr, 90409, Germany
MVZ OB-Sterkrade GmbH
Oberhausen, Rheinl, 46149, Germany
Dr. Müller
Potsdam, 14467, Germany
Dres. Hennig/Mikes
Radebeul, 01445, Germany
Dr. Dinh
Rathenow, 14712, Germany
Zentrum für Onkologie
Rostock, 18107, Germany
Lungenfachzentrum Rhein-Main
Rüsselsheim am Main, 65428, Germany
Lungenzentrum Schleswig
Schleswig, 24837, Germany
Dres. Korupp/Rose
Schweinfurt, 97421, Germany
Dr. Theuer
Seelow, 15306, Germany
Praxis S. Schmidt
Siegen, 57072, Germany
Dres. Knöbel und Partner
Straubing, 94315, Germany
Dr. Rother
Strausberg, 15344, Germany
Marienhospital Stuttgart
Stuttgart, 70199, Germany
Dr. Schmidt-Reinwald
Trier, 54292, Germany
Lungenzentrum Ulm
Ulm, Donau, 89073, Germany
Dres. Günther/Günther
Viernheim, 68519, Germany
Dres. Waltert/Esselmann
Warendorf, 48231, Germany
Dres. Herold/Kaa
Weißenburg I Bay, 91781, Germany
Dres. Fried/Rubin
Wiesbaden, 65183, Germany
Dr. Franz
Witten, 58452, Germany
Dr. Weber
Witten, 58452, Germany
Related Publications (2)
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: 37256536DERIVEDBuhl 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.
PMID: 33122898DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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. Less 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.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Andrea Marseille, 0049613277141881
andrea.marseille@boehringer-ingelheim.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2019
First Posted
May 17, 2019
Study Start
June 7, 2019
Primary Completion
June 30, 2021
Study Completion
September 30, 2021
Last Updated
April 24, 2024
Results First Posted
March 15, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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.
- Access Criteria
- 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'.
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". Also, 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. The data shared are the raw clinical study data sets.