DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy (DETECT)
10. desember 2018 oppdatert av: AstraZeneca
Non-interventional Study for Documentation of the Therapeutic Efficacy, Use and Tolerance of the Fixed-Dose Combinations (FDC) Duaklir® Genuair® (Aclidinium/Formoterol), Ultibro® Breezhaler® (Glycopyrronium/Indacaterol) and Anoro® (Umeclidinium/Vilanterol) in the Treatment of COPD Under Real Conditions in the Practices of Pneumologists, Internists, and General Practitioners
Prospective, multi-centre, non-interventional study to collect findings about the effects of LABA/LAMA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists) combination preparations on COPD (Chronic obstructive pulmonary disease) symptoms and quality of life under real conditions and to find out what types of patients are selected for this therapy by physicians.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Retrospective aspect of documentation: For patients who have already been changed over to a fixed-dose combination, lung function parameters and CAT (COPD Assessment Test™) score from the time prior to the changeover will be documented.
Studietype
Observasjonsmessig
Registrering (Faktiske)
3732
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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D6570r00001
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Aachen, D6570r00001, Tyskland, D6570R00001
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Aldenhofen, D6570r00001, Tyskland, D6570R00001
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Aldenhoven, D6570r00001, Tyskland, D6570R00001
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Alzey, D6570r00001, Tyskland, D6570R00001
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Ansbach, D6570r00001, Tyskland, D6570R00001
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Apolda, D6570r00001, Tyskland, D6570R00001
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Aschau, D6570r00001, Tyskland, D6570R00001
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Auerbach, D6570r00001, Tyskland, D6570R00001
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Augsburg, D6570r00001, Tyskland, D6570R00001
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Bad Fallingbostel, D6570r00001, Tyskland, D6570R00001
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Bad Hersfeld, D6570r00001, Tyskland, D6570R00001
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Bad Honnef, D6570r00001, Tyskland, D6570R00001
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Bad Lippspringe, D6570r00001, Tyskland, D6570R00001
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Bad Reichenhall, D6570r00001, Tyskland, D6570R00001
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Bad Sachsa, D6570r00001, Tyskland, D6570R00001
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Bad Windsheim, D6570r00001, Tyskland, D6570R00001
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Bad Woerishofen, D6570r00001, Tyskland, D6570R00001
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Bamberg, D6570r00001, Tyskland, D6570R00001
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Beelitz-Heilstaetten, D6570r00001, Tyskland, D6570R00001
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Bergisch Gladbach, D6570r00001, Tyskland, D6570R00001
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Berlin, D6570r00001, Tyskland, D6570R00001
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Biberach, D6570r00001, Tyskland, D6570R00001
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Birkenwerder, D6570r00001, Tyskland, D6570R00001
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Bitterfeld-Wolfen, D6570r00001, Tyskland, D6570R00001
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Bochum, D6570r00001, Tyskland, D6570R00001
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Boehlen, D6570r00001, Tyskland, D6570R00001
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Bonn, D6570r00001, Tyskland, D6570R00001
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Bottrop, D6570r00001, Tyskland, D6570R00001
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Braunschweig, D6570r00001, Tyskland, D6570R00001
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Bruchsal, D6570r00001, Tyskland, D6570R00001
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Buechen, D6570r00001, Tyskland, D6570R00001
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Burghaslach, D6570r00001, Tyskland, D6570R00001
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Burgwedel, D6570r00001, Tyskland, D6570R00001
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Celle, D6570r00001, Tyskland, D6570R00001
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Chemnitz, D6570r00001, Tyskland, D6570R00001
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Cottbus, D6570r00001, Tyskland, D6570R00001
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Darmstadt, D6570r00001, Tyskland, D6570R00001
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Delitzsch, D6570r00001, Tyskland, D6570R00001
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Dessau, D6570r00001, Tyskland, D6570R00001
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Dorsten, D6570r00001, Tyskland, D6570R00001
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Dortmund, D6570r00001, Tyskland, D6570R00001
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Dresden, D6570r00001, Tyskland, D6570R00001
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Dueren, D6570r00001, Tyskland, D6570R00001
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Duesseldorf, D6570r00001, Tyskland, D6570R00001
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Duisburg, D6570r00001, Tyskland, D6570R00001
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Eimsheim, D6570r00001, Tyskland, D6570R00001
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Ellerstadt, D6570r00001, Tyskland, D6570R00001
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Elsterwerda, D6570r00001, Tyskland, D6570R00001
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Elterlein, D6570r00001, Tyskland, D6570R00001
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Essen, D6570r00001, Tyskland, D6570R00001
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Euerbach-Obbach, D6570r00001, Tyskland, D6570R00001
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Euskirchen, D6570r00001, Tyskland, D6570R00001
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Flensburg, D6570r00001, Tyskland, D6570R00001
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Frankfurt, D6570r00001, Tyskland, D6570R00001
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Frankfurt/M., D6570r00001, Tyskland, D6570R00001
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Freiberg, D6570r00001, Tyskland, D6570R00001
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Fuerstenwalde, D6570r00001, Tyskland, D6570R00001
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Fuerth, D6570r00001, Tyskland, D6570R00001
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Ganderkesee, D6570r00001, Tyskland, D6570R00001
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Garching, D6570r00001, Tyskland, D6570R00001
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Garmisch-Partenkirchen, D6570r00001, Tyskland, D6570R00001
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Gauting, D6570r00001, Tyskland, D6570R00001
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Gera, D6570r00001, Tyskland, D6570R00001
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Gerwisch, D6570r00001, Tyskland, D6570R00001
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Glienicke, D6570r00001, Tyskland, D6570R00001
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Greiz, D6570r00001, Tyskland, D6570R00001
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Guetersloh, D6570r00001, Tyskland, D6570R00001
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Hagen, D6570r00001, Tyskland, D6570R00001
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Halberstadt, D6570r00001, Tyskland, D6570R00001
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Halle, D6570r00001, Tyskland, D6570R00001
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Hamburg, D6570r00001, Tyskland, D6570R00001
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Hannover, D6570r00001, Tyskland, D6570R00001
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Hartenstein, D6570r00001, Tyskland, D6570R00001
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Heidelberg, D6570r00001, Tyskland, D6570R00001
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Hemmingen, D6570r00001, Tyskland, D6570R00001
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Hettstedt, D6570r00001, Tyskland, D6570R00001
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Hoechstadt, D6570r00001, Tyskland, D6570R00001
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Hoyerswerda, D6570r00001, Tyskland, D6570R00001
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Ibbenbueren, D6570r00001, Tyskland, D6570R00001
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Ingolstadt, D6570r00001, Tyskland, D6570R00001
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Iserlohn, D6570r00001, Tyskland, D6570R00001
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Issum, D6570r00001, Tyskland, D6570R00001
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Jena, D6570r00001, Tyskland, D6570R00001
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Karlsruhe, D6570r00001, Tyskland, D6570R00001
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Kevelaer, D6570r00001, Tyskland, D6570R00001
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Kleve, D6570r00001, Tyskland, D6570R00001
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Koeln, D6570r00001, Tyskland, D6570R00001
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Koeln-Hoehenberg, D6570r00001, Tyskland, D6570R00001
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Koeln-Rodenkirchen, D6570r00001, Tyskland, D6570R00001
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Koethen, D6570r00001, Tyskland, D6570R00001
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Kolbermoor, D6570r00001, Tyskland, D6570R00001
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Krefeld, D6570r00001, Tyskland, D6570R00001
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Kronach, D6570r00001, Tyskland, D6570R00001
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Kyritz, D6570r00001, Tyskland, D6570R00001
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Langenfeld, D6570r00001, Tyskland, D6570R00001
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Leer, D6570r00001, Tyskland, D6570R00001
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Leipzig, D6570r00001, Tyskland, D6570R00001
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Leonberg, D6570r00001, Tyskland, D6570R00001
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Lippstadt, D6570r00001, Tyskland, D6570R00001
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Ludwigsburg-Ossweil, D6570r00001, Tyskland, D6570R00001
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Ludwigshafen, D6570r00001, Tyskland, D6570R00001
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Luebeck, D6570r00001, Tyskland, D6570R00001
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Magdeburg, D6570r00001, Tyskland, D6570R00001
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Mainz, D6570r00001, Tyskland, D6570R00001
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Mannheim, D6570r00001, Tyskland, D6570R00001
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Marburg, D6570r00001, Tyskland, D6570R00001
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Markt Bibart, D6570r00001, Tyskland, D6570R00001
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Menden, D6570r00001, Tyskland, D6570R00001
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Merzig, D6570r00001, Tyskland, D6570R00001
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Moenchengladbach, D6570r00001, Tyskland, D6570R00001
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Moers, D6570r00001, Tyskland, D6570R00001
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Monheim, D6570r00001, Tyskland, D6570R00001
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Mosbach, D6570r00001, Tyskland, D6570R00001
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Muehlhausen, D6570r00001, Tyskland, D6570R00001
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Muenchen, D6570r00001, Tyskland, D6570R00001
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Neumarkt, D6570r00001, Tyskland, D6570R00001
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Neunkirchen, D6570r00001, Tyskland, D6570R00001
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Neuruppin, D6570r00001, Tyskland, D6570R00001
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Neusaess, D6570r00001, Tyskland, D6570R00001
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Neustadt/Aisch, D6570r00001, Tyskland, D6570R00001
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Neuwied, D6570r00001, Tyskland, D6570R00001
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Nuernberg, D6570r00001, Tyskland, D6570R00001
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Oettingen, D6570r00001, Tyskland, D6570R00001
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Oschatz, D6570r00001, Tyskland, D6570R00001
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Oy-Mittelberg, D6570r00001, Tyskland, D6570R00001
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Pirmasens, D6570r00001, Tyskland, D6570R00001
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Potsdam, D6570r00001, Tyskland, D6570R00001
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Pulheim-Braunweiler, D6570r00001, Tyskland, D6570R00001
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Radebeul, D6570r00001, Tyskland, D6570R00001
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Rastatt, D6570r00001, Tyskland, D6570R00001
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Rathenow, D6570r00001, Tyskland, D6570R00001
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Recklinghausen, D6570r00001, Tyskland, D6570R00001
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Remscheid, D6570r00001, Tyskland, D6570R00001
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Reutlingen, D6570r00001, Tyskland, D6570R00001
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Rosenheim, D6570r00001, Tyskland, D6570R00001
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Rostock, D6570r00001, Tyskland, D6570R00001
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Roth, D6570r00001, Tyskland, D6570R00001
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Ruedersdorf, D6570r00001, Tyskland, D6570R00001
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Ruesselsheim, D6570r00001, Tyskland, D6570R00001
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Rust, D6570r00001, Tyskland, D6570R00001
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Saalfeld, D6570r00001, Tyskland, D6570R00001
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Saarbruecken, D6570r00001, Tyskland, D6570R00001
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Saarlouis, D6570r00001, Tyskland, D6570R00001
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Schleswig, D6570r00001, Tyskland, D6570R00001
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Schmoelln, D6570r00001, Tyskland, D6570R00001
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Schoenbrunn, D6570r00001, Tyskland, D6570R00001
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Schwedt, D6570r00001, Tyskland, D6570R00001
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Siegen, D6570r00001, Tyskland, D6570R00001
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Simmern, D6570r00001, Tyskland, D6570R00001
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Solingen, D6570r00001, Tyskland, D6570R00001
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Sonsbeck, D6570r00001, Tyskland, D6570R00001
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Spiesen, D6570r00001, Tyskland, D6570R00001
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Spremberg, D6570r00001, Tyskland, D6570R00001
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Steinhagen, D6570r00001, Tyskland, D6570R00001
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Strasskirchen, D6570r00001, Tyskland, D6570R00001
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Strausberg, D6570r00001, Tyskland, D6570R00001
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Stuttgart, D6570r00001, Tyskland, D6570R00001
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Sulzberg, D6570r00001, Tyskland, D6570R00001
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Teterow, D6570r00001, Tyskland, D6570R00001
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Teuchern, D6570r00001, Tyskland, D6570R00001
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Thaleischweiler-Froeschen, D6570r00001, Tyskland, D6570R00001
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Trier, D6570r00001, Tyskland, D6570R00001
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Ulm, D6570r00001, Tyskland, D6570R00001
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Unterwellenborn, D6570r00001, Tyskland, D6570R00001
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Ursensollen, D6570r00001, Tyskland, D6570R00001
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Voerde, D6570r00001, Tyskland, D6570R00001
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Wallenhorst, D6570r00001, Tyskland, D6570R00001
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Wardenburg, D6570r00001, Tyskland, D6570R00001
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Waren, D6570r00001, Tyskland, D6570R00001
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Warendorf, D6570r00001, Tyskland, D6570R00001
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Wehrheim, D6570r00001, Tyskland, D6570R00001
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Weilheim, D6570r00001, Tyskland, D6570R00001
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Weissenburg, D6570r00001, Tyskland, D6570R00001
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Weisswasser, D6570r00001, Tyskland, D6570R00001
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Wiesbaden, D6570r00001, Tyskland, D6570R00001
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Witten, D6570r00001, Tyskland, D6570R00001
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Wittenberg, D6570r00001, Tyskland, D6570R00001
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Worms, D6570r00001, Tyskland, D6570R00001
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Wuppertal, D6570r00001, Tyskland, D6570R00001
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Zwoenitz, D6570r00001, Tyskland, D6570R00001
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Patients who have been diagnosed with COPD (Chronic obstructive pulmonary disease), who have been changed over within the last 3 months to one of the 3 listed fixed-dose combinations (FDC) or for whom such a changeover is intended, and whose lung function parameters and CAT (COPD Assessment Test™) score from the time prior to the changeover are available (within the last 6 months) or are determined at the time of the 1st visit, if this is planned as part of the routine treatment.
Beskrivelse
Inclusion Criteria:
- Female/male of at least 40 years of age
- Patient diagnosed with COPD
- Patient was changed over within the last 3 months to a fixed-dose combination (FDC) (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol), or there is already the intent to change the patient over to a fixed-dose combination (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol).
- Lung function parameters and CAT score from the time prior to the changeover to an FDC are on record (within the last 6 months in the case of patients who have already been changed over) or are determined at the 1st visit (in the case of patients who have not yet been changed over but for whom such a changeover is intended).
- Signed declaration of consent
Exclusion Criteria:
- The prescribing information for the fixed-dose combinations (Duaklir® Genuair®, Ulibtro® Breezhaler® or Anoro®) list contraindications for the patient.
- Patient is pregnant, plans to become pregnant, or is nursing during the therapy period.
- Patient suffers from hypersensitivity to one of the active ingredients of the fixed-dose combinations.
- Patient is participating in a clinical trial.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Patients on Duaklir® Genuair®
Patients on fixed-dose combination Duaklir® Genuair® (Aclidinium/Formoterol)
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Patients on Ultibro® Breezhaler®
Patients on fixed-dose combination Ultibro® Breezhaler® (Glycopyrronium/Indacaterol)
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Patients on Anoro®
Patients on fixed-dose combination Anoro® (Umeclidinium/Vilanterol)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Lung function
Tidsramme: First visit (baseline)
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Assessment of FEV1 (Forced Expiratory Volume), FVC (Forced Vital Capacity)
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First visit (baseline)
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Number of patients with concomitant diseases classified by diagnostic subgroups
Tidsramme: First visit (baseline)
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First visit (baseline)
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Number of patients receiving concomitant COPD (Chronic obstructive pulmonary disease) medication classified by therapeutic subgroups
Tidsramme: First visit (baseline)
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First visit (baseline)
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Number of patients with exacerbations within the previous 24 months
Tidsramme: First visit (baseline)
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History of previous exacerbations that will be collected at first observational visit.
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First visit (baseline)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in well-being and quality of life
Tidsramme: First visit (baseline) to end of observational period at 12 months
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CAT (COPD Assessment Test™) questionnaire will be completed at each visit, approximately every 3 months.
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First visit (baseline) to end of observational period at 12 months
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Effect on the severity of the shortness of breath
Tidsramme: First visit (baseline) to end of observational period at 12 months
|
mMRC (modified Medical Research Council Dyspnea Scale) questionnaire will be completed at each visit, approximately every 3 months.
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First visit (baseline) to end of observational period at 12 months
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Change in the night-time and early-morning COPD symptoms
Tidsramme: First visit (baseline) to end of observational period at 12 months
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NiSCI/EMSCI (Night-time symptoms of COPD Instrument / Early-morning symptoms of COPD instrument) questionnaire will be completed at each visit, approximately every 3 months.
|
First visit (baseline) to end of observational period at 12 months
|
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Lung function
Tidsramme: First visit (baseline) to end of observational period at 12 months
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Assessment of FEV1, FVC at each visit, approximately every 3 months.
|
First visit (baseline) to end of observational period at 12 months
|
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Number of exacerbations by grade
Tidsramme: First visit (baseline) to end of observational period at 12 months
|
Number of exacerbations will be collected at each visit, approximately every 3 months
|
First visit (baseline) to end of observational period at 12 months
|
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Adverse events
Tidsramme: First visit (baseline) to end of observational period at 12 months
|
Adverse events will be collected at each visit, approximately every 3 months.
|
First visit (baseline) to end of observational period at 12 months
|
|
Handling of inhaler
Tidsramme: At 12 months
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Questionnaire regarding handling of inhaler by patient
|
At 12 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
24. september 2015
Primær fullføring (Faktiske)
31. desember 2017
Studiet fullført (Faktiske)
31. desember 2017
Datoer for studieregistrering
Først innsendt
29. juli 2015
Først innsendt som oppfylte QC-kriteriene
16. september 2015
Først lagt ut (Anslag)
17. september 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. desember 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. desember 2018
Sist bekreftet
1. desember 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D6570R00001
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