A Non-Interventional Study of Tiotropium/Olodaterol versus Any Triple Combination Therapy for Chronic Obstructive Pulmonary Disease: The EVELUT® Study Protocol
Roland Buhl,1 Michael Dreher,2 Stephanie Korn,1 Christian Taube,3 Christian Stock,4 Christoph M Zehendner,5 Anke Kondla,5 Claus F Vogelmeier6 1Pulmonary Department, Johannes Gutenberg University Mainz, Mainz, Germany; 2Clinic of Cardiology, Pneumology, Angiology and Internal Medicine Intensive Care,...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2020-10-01
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| Series: | International Journal of COPD |
| Subjects: | |
| Online Access: | https://www.dovepress.com/a-non-interventional-study-of-tiotropiumolodaterol-versus-any-triple-c-peer-reviewed-article-COPD |
| _version_ | 1818317999798484992 |
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| author | Buhl R Dreher M Korn S Taube C Stock C Zehendner CM Kondla A Vogelmeier CF |
| author_facet | Buhl R Dreher M Korn S Taube C Stock C Zehendner CM Kondla A Vogelmeier CF |
| author_sort | Buhl R |
| collection | DOAJ |
| description | Roland Buhl,1 Michael Dreher,2 Stephanie Korn,1 Christian Taube,3 Christian Stock,4 Christoph M Zehendner,5 Anke Kondla,5 Claus F Vogelmeier6 1Pulmonary Department, Johannes Gutenberg University Mainz, Mainz, Germany; 2Clinic of Cardiology, Pneumology, Angiology and Internal Medicine Intensive Care, University Hospital RWTH Aachen, Aachen, Germany; 3Clinic for Pneumonology, University Medicine Essen – Ruhrlandklinik, Essen, Germany; 4Biostatistics + Data Sciences Corp, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; 5HP Country Medical Affairs, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; 6Department of Pneumology, University Hospital of Giessen and Marburg, Member of the German Center for Lung Research (DZL), Marburg, GermanyCorrespondence: Roland BuhlPulmonary Department, Johannes Gutenberg University Mainz, Langenbeckstraße 1, Mainz D-55131, GermanyTel +49 6131 17-7271Email roland.buhl@unimedizin-mainz.deBackground: The Global Initiative for Chronic Obstructive Lung Disease 2020 report recommends that patients with chronic obstructive pulmonary disease (COPD) suffering from persistent dyspnea, despite long-acting β2-agonist (LABA)/inhaled corticosteroid (ICS) maintenance therapy, are switched to either a long-acting muscarinic antagonist (LAMA)/LABA combination regimen or LAMA/LABA/ICS triple therapy. However, to date, no studies have investigated the direct switch from LABA/ICS to LAMA/LABA therapy—instead of switching to triple therapy—in a prospective, real-world, non-interventional setting.Methods: EVELUT® (NCT03954132) is an ongoing, prospective, open-label, multicenter, non-interventional study comparing the once-daily fixed-dose combination of tiotropium and olodaterol (tio/olo) versus any triple therapy (LAMA/LABA/ICS) in patients with COPD who are symptomatic despite LABA/ICS maintenance therapy. Patients with acute or frequent COPD exacerbations are excluded from the study. Participants will receive LABA/ICS maintenance treatment until Visit 1, followed by switching of treatment to tio/olo or LAMA/LABA/ICS. The primary endpoints are changes in modified Medical Research Council (mMRC) and COPD Assessment Test (CAT®) scores after approximately 12 weeks of treatment. Secondary endpoints are change in the patients’ general condition according to the Physician’s Global Evaluation score, the proportion of responders with a change in mMRC score of ≥ 1 and in CAT® score of ≥ 2, and patient satisfaction with the inhaler and therapy. The study is expected to enroll approximately 900 patients.Conclusion: EVELUT results are expected to add to the current real-world evidence informing therapeutic decisions for COPD in everyday clinical practice.Trial Registration: The European Union electronic Register of Post-authorisation Studies (EU PAS Register): EUPAS29784; the Federal Institute for Drugs and Medical Devices (BfArM): NIS Study No 7305; Clinicaltrials.gov: NCT03954132.Keywords: COPD, tiotropium/olodaterol, Spiolto® Respimat®, triple therapy, LAMA/LABA/ICS |
| first_indexed | 2024-12-13T09:46:15Z |
| format | Article |
| id | doaj.art-57ab789d592b43fbae04d1fc3523fc3f |
| institution | Directory Open Access Journal |
| issn | 1178-2005 |
| language | English |
| last_indexed | 2024-12-13T09:46:15Z |
| publishDate | 2020-10-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | International Journal of COPD |
| spelling | doaj.art-57ab789d592b43fbae04d1fc3523fc3f2022-12-21T23:52:03ZengDove Medical PressInternational Journal of COPD1178-20052020-10-01Volume 152601260858413A Non-Interventional Study of Tiotropium/Olodaterol versus Any Triple Combination Therapy for Chronic Obstructive Pulmonary Disease: The EVELUT® Study ProtocolBuhl RDreher MKorn STaube CStock CZehendner CMKondla AVogelmeier CFRoland Buhl,1 Michael Dreher,2 Stephanie Korn,1 Christian Taube,3 Christian Stock,4 Christoph M Zehendner,5 Anke Kondla,5 Claus F Vogelmeier6 1Pulmonary Department, Johannes Gutenberg University Mainz, Mainz, Germany; 2Clinic of Cardiology, Pneumology, Angiology and Internal Medicine Intensive Care, University Hospital RWTH Aachen, Aachen, Germany; 3Clinic for Pneumonology, University Medicine Essen – Ruhrlandklinik, Essen, Germany; 4Biostatistics + Data Sciences Corp, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; 5HP Country Medical Affairs, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; 6Department of Pneumology, University Hospital of Giessen and Marburg, Member of the German Center for Lung Research (DZL), Marburg, GermanyCorrespondence: Roland BuhlPulmonary Department, Johannes Gutenberg University Mainz, Langenbeckstraße 1, Mainz D-55131, GermanyTel +49 6131 17-7271Email roland.buhl@unimedizin-mainz.deBackground: The Global Initiative for Chronic Obstructive Lung Disease 2020 report recommends that patients with chronic obstructive pulmonary disease (COPD) suffering from persistent dyspnea, despite long-acting β2-agonist (LABA)/inhaled corticosteroid (ICS) maintenance therapy, are switched to either a long-acting muscarinic antagonist (LAMA)/LABA combination regimen or LAMA/LABA/ICS triple therapy. However, to date, no studies have investigated the direct switch from LABA/ICS to LAMA/LABA therapy—instead of switching to triple therapy—in a prospective, real-world, non-interventional setting.Methods: EVELUT® (NCT03954132) is an ongoing, prospective, open-label, multicenter, non-interventional study comparing the once-daily fixed-dose combination of tiotropium and olodaterol (tio/olo) versus any triple therapy (LAMA/LABA/ICS) in patients with COPD who are symptomatic despite LABA/ICS maintenance therapy. Patients with acute or frequent COPD exacerbations are excluded from the study. Participants will receive LABA/ICS maintenance treatment until Visit 1, followed by switching of treatment to tio/olo or LAMA/LABA/ICS. The primary endpoints are changes in modified Medical Research Council (mMRC) and COPD Assessment Test (CAT®) scores after approximately 12 weeks of treatment. Secondary endpoints are change in the patients’ general condition according to the Physician’s Global Evaluation score, the proportion of responders with a change in mMRC score of ≥ 1 and in CAT® score of ≥ 2, and patient satisfaction with the inhaler and therapy. The study is expected to enroll approximately 900 patients.Conclusion: EVELUT results are expected to add to the current real-world evidence informing therapeutic decisions for COPD in everyday clinical practice.Trial Registration: The European Union electronic Register of Post-authorisation Studies (EU PAS Register): EUPAS29784; the Federal Institute for Drugs and Medical Devices (BfArM): NIS Study No 7305; Clinicaltrials.gov: NCT03954132.Keywords: COPD, tiotropium/olodaterol, Spiolto® Respimat®, triple therapy, LAMA/LABA/ICShttps://www.dovepress.com/a-non-interventional-study-of-tiotropiumolodaterol-versus-any-triple-c-peer-reviewed-article-COPDcopdtiotropium/olodaterolspiolto® respimat®triple therapylama/laba/ics |
| spellingShingle | 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® Study Protocol International Journal of COPD copd tiotropium/olodaterol spiolto® respimat® triple therapy lama/laba/ics |
| title | A Non-Interventional Study of Tiotropium/Olodaterol versus Any Triple Combination Therapy for Chronic Obstructive Pulmonary Disease: The EVELUT® Study Protocol |
| title_full | A Non-Interventional Study of Tiotropium/Olodaterol versus Any Triple Combination Therapy for Chronic Obstructive Pulmonary Disease: The EVELUT® Study Protocol |
| title_fullStr | A Non-Interventional Study of Tiotropium/Olodaterol versus Any Triple Combination Therapy for Chronic Obstructive Pulmonary Disease: The EVELUT® Study Protocol |
| title_full_unstemmed | A Non-Interventional Study of Tiotropium/Olodaterol versus Any Triple Combination Therapy for Chronic Obstructive Pulmonary Disease: The EVELUT® Study Protocol |
| title_short | A Non-Interventional Study of Tiotropium/Olodaterol versus Any Triple Combination Therapy for Chronic Obstructive Pulmonary Disease: The EVELUT® Study Protocol |
| title_sort | non interventional study of tiotropium olodaterol versus any triple combination therapy for chronic obstructive pulmonary disease the evelut reg study protocol |
| topic | copd tiotropium/olodaterol spiolto® respimat® triple therapy lama/laba/ics |
| url | https://www.dovepress.com/a-non-interventional-study-of-tiotropiumolodaterol-versus-any-triple-c-peer-reviewed-article-COPD |
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