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Pulmonary Disease, Chronic ObstructiveNCT03954132

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

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 75 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Spiolto® Respimat® and Triple-Therapy (LAMA/LABA/ICS)
How many people
469 participants
Where
75 sitesGermany
Study dates
7 Jun 2019to 30 Sep 2021
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Study is based on newly collected data from approximately 900 COPD patients from 150 recruiting sites in Germany.

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

75 sites in 1 country.

75 sites in 1 country

Germany75 sites

  • Dr. Graubner

    Bad Sachsa, 37441

  • Dr. Junggeburth

    Bad Wörishofen, 86825

  • Dr. Heinz

    Bergisch Gladbach, 51429

  • Praxis E. Hossbach

    Berkatal, 37297

  • Praxis an der Oper

    Berlin, 10625

  • Dr. Urban

    Berlin, 10711

  • Praxis A.Sahan/S. Erbil-Sahan

    Berlin, 12049

  • Dr. Kopf

    Berlin, 12459

  • Dr. Schwittay

    Böhlen B Leipzig, 04564

  • Dres. Pabst/Schlünz

    Bonn, 53123

  • Dres. Bartels/Bartels

    Breuberg, 64747

  • Dr. Grimm-Sachs

    Bruchsal, 76646

  • Praxis B. Metzlaff

    Büchen, 21514

  • Ambulantes Zentrum

    Cottbus, 03050

  • Lungenzentrum Darmstadt

    Darmstadt, 64283

  • Hausarzt Deggingen

    Deggingen, 73326

  • Dres. Tietjens

    Dortmund, 44135

  • Dr. Schwiese

    Duisburg, 47051

  • Schwerpunktpraxis

    Düsseldorf, 40217

  • Dr. Schmorell

    Forchheim, Oberfr, 91301

  • Praxis A. Xanthopoulos

    Fürstenwalde, 15517

  • Dr. Sommer

    Garmisch-Partenkirchen, 82467

  • Dres. Ern/Trilling

    Gelsenkirchen, 45879

  • Dr. Birkner

    Gelsenkirchen, 45881

  • Praxis C. Staack/Z. Zadrozny

    Gelsenkirchen, 45891

  • Das HausarztZentrum

    Grafenrheinfeld, 97506

  • Dres. Coesfeld/Gams/Gams

    Gütersloh, 33330

  • Pneumologicum Halle

    Halle, 06108

  • MVZ Martha-Maria gGmbH

    Halle, 06110

  • Dr. Knolinski

    Hamburg, 22459

  • Dres. Kaase/Lepinat

    Hamburg, 22529

  • Dr. Abenhardt

    Heidelberg, Neckar, 69115

  • Dr. Koch

    Heilbad Heiligenstadt, 37308

  • Dres Stolpe/ Roß

    Ibbenbueren, 49477

  • Dres. Lehmann/Schulze und Partner

    Jerichow, 39319

  • Dr. Beckmann

    Kamen, Westf, 59174

  • Praxis G. Mohanty

    Kamp-Lintfort, 47475

  • Dr. Auge

    Koblenz Am Rhein, 56068

  • Dres. Lehmann/Schulze und Partner

    Köthen, 06366

  • Dr. Pfitzer

    Kronach, Oberfr, 96317

  • Dres. Alshut/Weberling

    Lahnau, 35633

  • Dr. Einenkel

    Leipzig, 04109

  • Dr. Geßner

    Leipzig, 04357

  • Dr. Pitule

    Ludwigshafen am Rhein, 67061

  • Dr. Hladik

    Ludwigshafen am Rhein, 67063

  • Dr. Saur

    Mannheim, 68161

  • Dres. Jerrentrup/Mronga

    Marburg, 35037

  • Dr. Jansen

    Menden (Sauerland), 58706

  • Dr. Ingerl

    Mosbach, Baden, 74821

  • Dr. Feimer

    München, 80539

  • Thoraxzentrum Bez. Unterfranken

    Münnerstadt, 97702

  • Praxis Th. Hagen

    Neumarkt in der Oberpfalz, 92318

  • Praxis W. Wuttke

    Nuremberg, 90478

  • Dr. Laser

    Nürnberg, Mittelfr, 90409

  • MVZ OB-Sterkrade GmbH

    Oberhausen, Rheinl, 46149

  • Dr. Müller

    Potsdam, 14467

  • Dres. Hennig/Mikes

    Radebeul, 01445

  • Dr. Dinh

    Rathenow, 14712

  • Zentrum für Onkologie

    Rostock, 18107

  • Lungenfachzentrum Rhein-Main

    Rüsselsheim am Main, 65428

  • Lungenzentrum Schleswig

    Schleswig, 24837

  • Dres. Korupp/Rose

    Schweinfurt, 97421

  • Dr. Theuer

    Seelow, 15306

  • Praxis S. Schmidt

    Siegen, 57072

  • Dres. Knöbel und Partner

    Straubing, 94315

  • Dr. Rother

    Strausberg, 15344

  • Marienhospital Stuttgart

    Stuttgart, 70199

  • Dr. Schmidt-Reinwald

    Trier, 54292

  • Lungenzentrum Ulm

    Ulm, Donau, 89073

  • Dres. Günther/Günther

    Viernheim, 68519

  • Dres. Waltert/Esselmann

    Warendorf, 48231

  • Dres. Herold/Kaa

    Weißenburg I Bay, 91781

  • Dres. Fried/Rubin

    Wiesbaden, 65183

  • Dr. Franz

    Witten, 58452

  • Dr. Weber

    Witten, 58452

Other trials in Germany

About this study

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

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

Read the 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.

Being tested
Spiolto® Respimat®, Triple-Therapy (LAMA/LABA/ICS)
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spiolto® Respimat®Drug

    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)Drug

    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.

Study groups in NCT03954132
Study groupRoleWhat they receive
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.
Receives: Drug: Spiolto® Respimat®
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.
Receives: Drug: Triple-Therapy (LAMA/LABA/ICS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).

  2. 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.

    Measured: Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).

Secondary outcomes (5)

  1. Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline

    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).

    Measured: Baseline at Visit 1 (day 0)

  2. Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period

    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).

    Measured: Visit 2 (planned at 12 week, up to a maximum of 42 weeks)

  3. Patient Satisfaction With Inhaler and Therapy at End of Observation Period

    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).

    Measured: Visit 2 (planned at 12 week, up to a maximum of 42 weeks).

  4. Number of Responders With Δ mMRC≥ 1

    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).

    Measured: Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).

  5. Number of Responders With Δ CAT≥ 2

    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.

    Measured: Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2019
  2. Study start7 Jun 2019
  3. Primary completion30 Jun 2021
  4. Study completion30 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
469 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03954132
Sponsor's protocol ID
1237-0087
Status last verified
Apr 2024
First submitted
15 May 2019
Last updated
24 Apr 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37256536

  • 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.

    PubMed 33122898

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 75 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03954132, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.

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