Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)

April 18, 2024 updated by: Boehringer Ingelheim

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

Open-label comparative multicentric cohort study in COPD patients with LABA/ICS, switched to either tiotropium/olodaterol and observed for 12 weeks approximately.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

469

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Sachsa, Germany, 37441
        • Dr. Graubner
      • Bad Wörishofen, Germany, 86825
        • Dr. Junggeburth
      • Bergisch Gladbach, Germany, 51429
        • Dr. Heinz
      • Berkatal, Germany, 37297
        • Praxis E. Hossbach
      • Berlin, Germany, 10711
        • Dr. Urban
      • Berlin, Germany, 12459
        • Dr. Kopf
      • Berlin, Germany, 10625
        • Praxis an der Oper
      • Berlin, Germany, 12049
        • Praxis A.Sahan/S. Erbil-Sahan
      • Bonn, Germany, 53123
        • Dres. Pabst/Schlünz
      • Breuberg, Germany, 64747
        • Dres. Bartels/Bartels
      • Bruchsal, Germany, 76646
        • Dr. Grimm-Sachs
      • Böhlen B Leipzig, Germany, 04564
        • Dr. Schwittay
      • Büchen, Germany, 21514
        • Praxis B. Metzlaff
      • Cottbus, Germany, 03050
        • Ambulantes Zentrum
      • Darmstadt, Germany, 64283
        • Lungenzentrum Darmstadt
      • Deggingen, Germany, 73326
        • Hausarzt Deggingen
      • Dortmund, Germany, 44135
        • Dres. Tietjens
      • Duisburg, Germany, 47051
        • Dr. Schwiese
      • Düsseldorf, Germany, 40217
        • Schwerpunktpraxis
      • Forchheim, Oberfr, Germany, 91301
        • Dr. Schmorell
      • Fürstenwalde /Spree, Germany, 15517
        • Praxis A. Xanthopoulos
      • Garmisch-Partenkirchen, Germany, 82467
        • Dr. Sommer
      • Gelsenkirchen, Germany, 45891
        • Praxis C. Staack/Z. Zadrozny
      • Gelsenkirchen, Germany, 45879
        • Dres. Ern/Trilling
      • Gelsenkirchen, Germany, 45881
        • Dr. Birkner
      • Grafenrheinfeld, Germany, 97506
        • Das HausarztZentrum
      • Gütersloh, Germany, 33330
        • Dres. Coesfeld/Gams/Gams
      • Halle (Saale), Germany, 06108
        • Pneumologicum Halle
      • Halle (Saale), Germany, 06110
        • MVZ Martha-Maria gGmbH
      • Hamburg, Germany, 22459
        • Dr. Knolinski
      • Hamburg, Germany, 22529
        • Dres. Kaase/Lepinat
      • Heidelberg, Neckar, Germany, 69115
        • Dr. Abenhardt
      • Heilbad Heiligenstadt, Germany, 37308
        • Dr. Koch
      • Ibbenbüren, Germany, 49477
        • Dres Stolpe/ Roß
      • Jerichow, Germany, 39319
        • Dres. Lehmann/Schulze und Partner
      • Kamen, Westf, Germany, 59174
        • Dr. Beckmann
      • Kamp-Lintfort, Germany, 47475
        • Praxis G. Mohanty
      • Koblenz Am Rhein, Germany, 56068
        • Dr. Auge
      • Kronach, Oberfr, Germany, 96317
        • Dr. Pfitzer
      • Köthen (Anhalt), Germany, 06366
        • Dres. Lehmann/Schulze und Partner
      • Lahnau, Germany, 35633
        • Dres. Alshut/Weberling
      • Leipzig, Germany, 04109
        • Dr. Einenkel
      • Leipzig, Germany, 04357
        • Dr. Geßner
      • Ludwigshafen am Rhein, Germany, 67061
        • Dr. Pitule
      • Ludwigshafen am Rhein, Germany, 67063
        • Dr. Hladik
      • Mannheim, Germany, 68161
        • Dr. Saur
      • Marburg, Germany, 35037
        • Dres. Jerrentrup/Mronga
      • Menden (Sauerland), Germany, 58706
        • Dr. Jansen
      • Mosbach, Baden, Germany, 74821
        • Dr. Ingerl
      • München, Germany, 80539
        • Dr. Feimer
      • Münnerstadt, Germany, 97702
        • Thoraxzentrum Bez. Unterfranken
      • Neumarkt i.d.OPf., Germany, 92318
        • Praxis Th. Hagen
      • Nürnberg, Germany, 90478
        • Praxis W. Wuttke
      • Nürnberg, Mittelfr, Germany, 90409
        • Dr. Laser
      • Oberhausen, Rheinl, Germany, 46149
        • MVZ OB-Sterkrade GmbH
      • Potsdam, Germany, 14467
        • Dr. Müller
      • Radebeul, Germany, 01445
        • Dres. Hennig/Mikes
      • Rathenow, Germany, 14712
        • Dr. Dinh
      • Rostock, Germany, 18107
        • Zentrum für Onkologie
      • Rüsselsheim, Germany, 65428
        • Lungenfachzentrum Rhein-Main
      • Schleswig, Germany, 24837
        • Lungenzentrum Schleswig
      • Schweinfurt, Germany, 97421
        • Dres. Korupp/Rose
      • Seelow, Germany, 15306
        • Dr. Theuer
      • Siegen, Germany, 57072
        • Praxis S. Schmidt
      • Straubing, Germany, 94315
        • Dres. Knöbel und Partner
      • Strausberg, Germany, 15344
        • Dr. Rother
      • Stuttgart, Germany, 70199
        • Marienhospital Stuttgart
      • Trier, Germany, 54292
        • Dr. Schmidt-Reinwald
      • Ulm, Donau, Germany, 89073
        • Lungenzentrum Ulm
      • Viernheim, Germany, 68519
        • Dres. Günther/Günther
      • Warendorf, Germany, 48231
        • Dres. Waltert/Esselmann
      • Weißenburg I Bay, Germany, 91781
        • Dres. Herold/Kaa
      • Wiesbaden, Germany, 65183
        • Dres. Fried/Rubin
      • Witten, Germany, 58452
        • Dr. Franz
      • Witten, Germany, 58452
        • Dr. Weber

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Modified Medical Research Council (mMRC) Score Between Baseline and After End of Observation
Time Frame: Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).
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)
Time Frame: Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline
Time Frame: Baseline at Visit 1 (day 0)
The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1-2 (poor), 3-4 (satisfactory), 5-6 (good) to 7-8 (excellent).
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
Time Frame: Visit 2 (planned at 12 week, up to a maximum of 42 weeks)
The treating physician will use the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).
Visit 2 (planned at 12 week, up to a maximum of 42 weeks)
Patient Satisfaction With Inhaler and Therapy at End of Observation Period
Time Frame: Visit 2 (planned at 12 week, up to a maximum of 42 weeks).
Patient satisfaction with inhaler and therapy at end of observation period according to a seven-point ordinal scale (ranging from very dissatisfied to very satisfied).
Visit 2 (planned at 12 week, up to a maximum of 42 weeks).
Number of Responders With Δ mMRC≥ 1
Time Frame: Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).
Number of responders with a change in modified Medical Research Council (mMRC) greater than or equal to 1 between visit 1 and 2. The mMRC was used to assess the severity of the breathlessness. the mMRC consists of five statements describing the patients grade of breathlessness ranging from 0 (best outcome) to 4 (worst outcome).
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
Time Frame: Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).
Number of responders with a change in the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) greater than or equal to 2 between visit 1 and 2.
Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

  • Study Chair: Andrea Marseille, 0049613277141881, andrea.marseille@boehringer-ingelheim.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2019

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

May 15, 2019

First Submitted That Met QC Criteria

May 15, 2019

First Posted (Actual)

May 17, 2019

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1237-0087

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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'.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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