Changes in Health and Functional Status in Patients With Chronic Obstructive Pulmonary Disease During Therapy With Spiolto® Respimat® (AERIAL®)
NCT ID: NCT03165045
Last Updated: 2020-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
1351 participants
OBSERVATIONAL
2017-05-26
2019-03-24
Brief Summary
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Detailed Description
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In visit 1, patient data on demographics, smoking status, medical history, breathlessness, general condition, health and functional status and adverse drug reactions will be collected. In visit 2, after approximately 6 weeks, data on smoking status, concomitant diseases and medication, general condition, health and functional status and adverse drug reactions will be collected; additionally data on patient satisfaction, continuation or discontinuation of treatment and the reason in case of discontinuation.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients treated with Spiolto® Respimat®
Patients with COPD
Spiolto® Respimat®
6 weeks
Interventions
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Spiolto® Respimat®
6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent prior to participation
* Female and male patients ≥40 years of age
* Patients diagnosed with COPD and requiring a combination of two long-acting bronchodilators (LAMA + LABA) according to approved SmPC and GOLD COPD guideline recommendation 2017 (GOLD COPD groups B to D)
* Treatment with Spiolto® Respimat® acc. to SmPC at the discretion of the physician.
Exclusion Criteria
* Patients already on a LABA/LAMA combination (free and fixed dose) in the last 6 weeks before study entry
* Patients continuing LABA-ICS treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
* Pregnancy and lactation
* Current participation in any clinical trial or any other non-interventional study of a drug or device.
40 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Dr. Weghmann
Aachen, , Germany
Praxis Edgar Schaubert
Aldenhoven, , Germany
MZM Medizin Zentr. Marienstrasse
Aldenhoven B Jülich, , Germany
Praxis Dr. Selbig
Ansbach, , Germany
Dr. Ludwig
Bad Bentheim, , Germany
Dr. Jung
Bad Ditzenbach, , Germany
Praxis Dr. med. Graubner
Bad Sachsa, , Germany
Dr. Callitsis
Bad Vilbel, , Germany
Dr. Junggeburth
Bad Wörishofen, , Germany
Praxis Edgar Hossbach
Berkatal-Frankershausen, , Germany
Dr. Urban
Berlin, , Germany
Praxis Abdullah Sahan
Berlin, , Germany
Dr. Kopf
Berlin, , Germany
Dr. Thalhofer
Berlin, , Germany
Gemeinschaftspraxis Dres. Wetterau/Dimar
Biberach, , Germany
Dr. Kassik
Bitterfeld-Wolfen, , Germany
Dr. Biedermann
Blankenhain , Thür, , Germany
Praxis Dr. Andreas Schwittay
Böhlen, , Germany
Gemeinschaftspraxis Dres. Bartels
Breuberg, , Germany
Dres. Ottlewski/Sutor
Burgwedel, , Germany
Praxis B. Metzlaff
Büchen, , Germany
Praxis A. Hermann/L. Hermann
Cloppenburg, , Germany
Praxis Dr. Käßner
Cottbus, , Germany
Dres. Forster/Kneser/Steinmetz
Darmstadt, , Germany
Dres. Jung/Jung
Deggingen, , Germany
Dr. Franz
Dietzenbach, , Germany
Dres. Tietjens/Tobias
Dortmund, , Germany
Dr. Schwiese
Duisburg, , Germany
Dr. Kontny
Duisburg, , Germany
Dres. Berger/Schäfer/Winkels
Düren, , Germany
Gemeinschaftspraxis Dres. Rommelmann/Lange/Geist/Neise
Düsseldorf, , Germany
Ges. f. Med. Fortbildung
Düsseldorf, , Germany
Praxis Dr. Andreas Kroll
Einbeck, , Germany
Dr. Schmidt
Erfurt, , Germany
Dres. Brüning/Schax
Essen, , Germany
Praxis Dr. Schmorell
Forchheim, , Germany
Dres. Engelhard/Wihl
Frankenberg, , Germany
Studienzentrum Dr. Klaus Keller
Frankfurt, , Germany
Dr. Morgner
Freiberg, , Germany
Allgemeinmedizinische Gemeinschaftspraxis Dres. Fischer/Fischer
Friedrichsthal, , Germany
Dr. Xanthopoulos
Fürstenwalde, , Germany
Praxis A. Heinze
Fürstenwalde, , Germany
Dr. Sommer
Garmisch-Partenkirchen, , Germany
Praxis C. Staack/Z. Zadrozny
Gelsenkirchen, , Germany
Praxis Dr. Körössy
Geretsried, , Germany
Das HausarztZentrum
Grafenrheinfeld, , Germany
Dres. Koenen & Partner
Grafenrheinfeld, , Germany
Praxis Dr. med. Werner Gams
Gütersloh, , Germany
Dr. Waida
Haan, , Germany
Pneumologicum Halle
Halle, , Germany
Praxis J. Lemke
Halle, , Germany
Dr. Polke
Hamburg, , Germany
Praxis Dr. Kaase
Hamburg, , Germany
Dr. Abenhardt
Heidelberg, , Germany
Praxis J. Hinrichs-Pavlik
Heidelberg , Neckar, , Germany
Praxis Dr. Constance Koch
Heilbad Heiligenstadt, , Germany
Praxis J. Korsakas
Heudeber, , Germany
Praxis Dres. Berg & Partner
Höchstadt an der Aisch, , Germany
Dr. Schulze
Jerichow, , Germany
Ambulantes Zentrum
Kalawa, , Germany
Dr. Schmitz
Kall, , Germany
Praxis Dr. Bernhard Beckmann
Kamen, , Germany
Praxis G. Mohanty
Kamp-Lintfort, , Germany
Praxis Dr. Dietrich Auge
Koblenz, , Germany
Dres. Lehmann/Schwerdtfeger
Köthen, , Germany
Praxis Dr. Astrid Pfitzer
Kronach, , Germany
KMG Klinikum Mitte GmbH
Kyritz , Prignitz, , Germany
Praxis Dr. Weberling
Lahnau, , Germany
POIS Leipzig GbR
Leipzig, , Germany
Dres. Bonitz/Hoheisel
Leipzig, , Germany
Dr. Seiz
Leonberg , Württ, , Germany
Praxis Dr. Hannelore Pitule
Ludwigshafen am Rhein, , Germany
Dres. Kock & Partner
Mainaschaff, , Germany
Dr. Saur
Mannheim, , Germany
Praxis Dr. Hermann A. Trauth
Marburg, , Germany
Gemeinschaftspraxis Dres. Jansen/Nolzen
Menden, , Germany
Dr. Bartsch
Moers, , Germany
Dr. Schipper
Monheim, , Germany
Praxis Hermann Ingerl
Mosbach, , Germany
Praxis Dr. Jan Feimer
München, , Germany
Thoraxzentrum Bez. Unterfranken
Münnerstadt, , Germany
Praxis Dipl. med Thomas Hagen
Neumarkt, , Germany
Praxis Wanda Wuttke
Nuremberg, , Germany
Praxis Dr. Volker E. Trapp
Nuremberg, , Germany
Praxis Dipl.-med. Anne-Kathrin Schmidt
Oschatz, , Germany
Dr. Bauer
Potsdam, , Germany
Praxis Dr. Rudolf Hennig
Radebeul, , Germany
Dr. Jasch-Hoppe
Rathenow, , Germany
Zentrum für Onkologie
Rostock, , Germany
Dres. Herold/Kaa
Roth , Mittelfr, , Germany
Lungenfachzentrum Rhein-Main
Rüsselsheim am Main, , Germany
MVZ für Atemwegserkrankungen
Schleswig, , Germany
Praxis S. Theuer
Seelow, , Germany
Dres. Knöbel/Olesch/Pelz-Knöbel
Straubing, , Germany
Dr. Eisenschmidt
Strausberg, , Germany
Dr. Schröter
Trier, , Germany
Dres. Barczok & Kollegen
Ulm, Donau, , Germany
Dres. Günther/Günther
Viernheim, , Germany
Überörtliche Gemeinschaftspraxis Dr. med. Albert Esselmann
Warendorf, , Germany
Dres. Herold/Kaa
Weißenburg I Bay, , Germany
Dres. Geissler/Geissler
Weißenfels, Saale, , Germany
Dres. Seidel/Röcher
Wiefelstede, , Germany
Dres. Fried/Thomas
Wiesbaden, , Germany
Praxis K.P. Schaps/H. Zimmeck
Wilhelmshaven, , Germany
Dr. Franz
Witten, , Germany
Dr. Weber
Witten, , Germany
Praxis D. Kubitscheck
Wittenberg, , Germany
Dr. Riegel
Wolfsburg, , Germany
Countries
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References
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Gillissen A, Marseille A, Skowasch D, Ritz J, Mattiucci-Guehlke M, Pabst S, Greulich T, Koczulla R. Health and functional status of tiotropium/olodaterol-treated patients with COPD: results from the AERIAL(R) non-interventional study. ERJ Open Res. 2021 Sep 6;7(3):00004-2021. doi: 10.1183/23120541.00004-2021. eCollection 2021 Jul.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1237-0065
Identifier Type: -
Identifier Source: org_study_id
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