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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03954132
• Other study ID #: 1237-0087
• Status: Completed
• Start date: June 7, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 469
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Germany	Dr. Graubner	Bad Sachsa
Germany	Dr. Junggeburth	Bad Wörishofen
Germany	Dr. Heinz	Bergisch Gladbach
Germany	Praxis E. Hossbach	Berkatal
Germany	Dr. Kopf	Berlin
Germany	Dr. Urban	Berlin
Germany	Praxis A.Sahan/S. Erbil-Sahan	Berlin
Germany	Praxis an der Oper	Berlin
Germany	Dr. Schwittay	Böhlen B Leipzig
Germany	Dres. Pabst/Schlünz	Bonn
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 /Spree
Germany	Dr. Sommer	Garmisch-Partenkirchen
Germany	Dr. Birkner	Gelsenkirchen
Germany	Dres. Ern/Trilling	Gelsenkirchen
Germany	Praxis C. Staack/Z. Zadrozny	Gelsenkirchen
Germany	Das HausarztZentrum	Grafenrheinfeld
Germany	Dres. Coesfeld/Gams/Gams	Gütersloh
Germany	MVZ Martha-Maria gGmbH	Halle (Saale)
Germany	Pneumologicum Halle	Halle (Saale)
Germany	Dr. Knolinski	Hamburg
Germany	Dres. Kaase/Lepinat	Hamburg
Germany	Dr. Abenhardt	Heidelberg, Neckar
Germany	Dr. Koch	Heilbad Heiligenstadt
Germany	Dres Stolpe/ Roß	Ibbenbüren
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 (Anhalt)
Germany	Dr. Pfitzer	Kronach, Oberfr
Germany	Dres. Alshut/Weberling	Lahnau
Germany	Dr. Einenkel	Leipzig
Germany	Dr. Geßner	Leipzig
Germany	Dr. Hladik	Ludwigshafen am Rhein
Germany	Dr. Pitule	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 i.d.OPf.
Germany	Praxis W. Wuttke	Nürnberg
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
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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	Change in CAT?? (COPD Assessment Test) Score Between Baseline and After End of Observation (ca. 12 Weeks of Treatment)	The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT??) was developed as a simple instrument to assess health status in patients with COPD. The CAT?? 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	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).	Baseline at Visit 1 (day 0)
Secondary	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).	Visit 2 (planned at 12 week, up to a maximum of 42 weeks)
Secondary	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).	Visit 2 (planned at 12 week, up to a maximum of 42 weeks).
Secondary	Number of Responders With ? 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).	Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).
Secondary	Number of Responders With ? 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.	Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).

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