Clinical trial NCT03954132: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-05-17
Enrollment: 469
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
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).
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).
Secondary outcomes:
measure: Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline
timeFrame: Baseline at Visit 1 (day 0)
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)
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).
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).
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).
Other outcomes:
Locations:
city: Bad Sachsa
country: Germany
facility: Dr. Graubner
city: Bad Wörishofen
country: Germany
facility: Dr. Junggeburth
city: Bergisch Gladbach
country: Germany
facility: Dr. Heinz
city: Berkatal
country: Germany
facility: Praxis E. Hossbach
city: Berlin
country: Germany
facility: Praxis an der Oper
city: Berlin
country: Germany
facility: Dr. Urban
city: Berlin
country: Germany
facility: Praxis A.Sahan/S. Erbil-Sahan
city: Berlin
country: Germany
facility: Dr. Kopf
city: Bonn
country: Germany
facility: Dres. Pabst/Schlünz
city: Breuberg
country: Germany
facility: Dres. Bartels/Bartels
city: Bruchsal
country: Germany
facility: Dr. Grimm-Sachs
city: Böhlen B Leipzig
country: Germany
facility: Dr. Schwittay
city: Büchen
country: Germany
facility: Praxis B. Metzlaff
city: Cottbus
country: Germany
facility: Ambulantes Zentrum
city: Darmstadt
country: Germany
facility: Lungenzentrum Darmstadt
city: Deggingen
country: Germany
facility: Hausarzt Deggingen
city: Dortmund
country: Germany
facility: Dres. Tietjens
city: Duisburg
country: Germany
facility: Dr. Schwiese
city: Düsseldorf
country: Germany
facility: Schwerpunktpraxis
city: Forchheim, Oberfr
country: Germany
facility: Dr. Schmorell
city: Fürstenwalde /Spree
country: Germany
facility: Praxis A. Xanthopoulos
city: Garmisch-Partenkirchen
country: Germany
facility: Dr. Sommer
city: Gelsenkirchen
country: Germany
facility: Dres. Ern/Trilling
city: Gelsenkirchen
country: Germany
facility: Dr. Birkner
city: Gelsenkirchen
country: Germany
facility: Praxis C. Staack/Z. Zadrozny
city: Grafenrheinfeld
country: Germany
facility: Das HausarztZentrum
city: Gütersloh
country: Germany
facility: Dres. Coesfeld/Gams/Gams
city: Halle (Saale)
country: Germany
facility: Pneumologicum Halle
city: Halle (Saale)
country: Germany
facility: MVZ Martha-Maria gGmbH
city: Hamburg
country: Germany
facility: Dr. Knolinski
city: Hamburg
country: Germany
facility: Dres. Kaase/Lepinat
city: Heidelberg, Neckar
country: Germany
facility: Dr. Abenhardt
city: Heilbad Heiligenstadt
country: Germany
facility: Dr. Koch
city: Ibbenbüren
country: Germany
facility: Dres Stolpe/ Roß
city: Jerichow
country: Germany
facility: Dres. Lehmann/Schulze und Partner
city: Kamen, Westf
country: Germany
facility: Dr. Beckmann
city: Kamp-Lintfort
country: Germany
facility: Praxis G. Mohanty
city: Koblenz Am Rhein
country: Germany
facility: Dr. Auge
city: Kronach, Oberfr
country: Germany
facility: Dr. Pfitzer
city: Köthen (Anhalt)
country: Germany
facility: Dres. Lehmann/Schulze und Partner
city: Lahnau
country: Germany
facility: Dres. Alshut/Weberling
city: Leipzig
country: Germany
facility: Dr. Einenkel
city: Leipzig
country: Germany
facility: Dr. Geßner
city: Ludwigshafen am Rhein
country: Germany
facility: Dr. Pitule
city: Ludwigshafen am Rhein
country: Germany
facility: Dr. Hladik
city: Mannheim
country: Germany
facility: Dr. Saur
city: Marburg
country: Germany
facility: Dres. Jerrentrup/Mronga
city: Menden (Sauerland)
country: Germany
facility: Dr. Jansen
city: Mosbach, Baden
country: Germany
facility: Dr. Ingerl
city: München
country: Germany
facility: Dr. Feimer
city: Münnerstadt
country: Germany
facility: Thoraxzentrum Bez. Unterfranken
city: Neumarkt i.d.OPf.
country: Germany
facility: Praxis Th. Hagen
city: Nürnberg, Mittelfr
country: Germany
facility: Dr. Laser
city: Nürnberg
country: Germany
facility: Praxis W. Wuttke
city: Oberhausen, Rheinl
country: Germany
facility: MVZ OB-Sterkrade GmbH
city: Potsdam
country: Germany
facility: Dr. Müller
city: Radebeul
country: Germany
facility: Dres. Hennig/Mikes
city: Rathenow
country: Germany
facility: Dr. Dinh
city: Rostock
country: Germany
facility: Zentrum für Onkologie
city: Rüsselsheim
country: Germany
facility: Lungenfachzentrum Rhein-Main
city: Schleswig
country: Germany
facility: Lungenzentrum Schleswig
city: Schweinfurt
country: Germany
facility: Dres. Korupp/Rose
city: Seelow
country: Germany
facility: Dr. Theuer
city: Siegen
country: Germany
facility: Praxis S. Schmidt
city: Straubing
country: Germany
facility: Dres. Knöbel und Partner
city: Strausberg
country: Germany
facility: Dr. Rother
city: Stuttgart
country: Germany
facility: Marienhospital Stuttgart
city: Trier
country: Germany
facility: Dr. Schmidt-Reinwald
city: Ulm, Donau
country: Germany
facility: Lungenzentrum Ulm
city: Viernheim
country: Germany
facility: Dres. Günther/Günther
city: Warendorf
country: Germany
facility: Dres. Waltert/Esselmann
city: Weißenburg I Bay
country: Germany
facility: Dres. Herold/Kaa
city: Wiesbaden
country: Germany
facility: Dres. Fried/Rubin
city: Witten
country: Germany
facility: Dr. Franz
city: Witten
country: Germany
facility: Dr. Weber
Study officials:
affiliation: andrea.marseille@boehringer-ingelheim.com
name: Andrea Marseille, 0049613277141881
role: STUDY_CHAIR
References:
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.