DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy (DETECT)
10 de dezembro de 2018 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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.
Tipo de estudo
Observacional
Inscrição (Real)
3732
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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D6570r00001
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Aachen, D6570r00001, Alemanha, D6570R00001
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Aldenhofen, D6570r00001, Alemanha, D6570R00001
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Aldenhoven, D6570r00001, Alemanha, D6570R00001
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Alzey, D6570r00001, Alemanha, D6570R00001
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Ansbach, D6570r00001, Alemanha, D6570R00001
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Apolda, D6570r00001, Alemanha, D6570R00001
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Aschau, D6570r00001, Alemanha, D6570R00001
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Auerbach, D6570r00001, Alemanha, D6570R00001
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Augsburg, D6570r00001, Alemanha, D6570R00001
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Bad Fallingbostel, D6570r00001, Alemanha, D6570R00001
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Bad Hersfeld, D6570r00001, Alemanha, D6570R00001
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Bad Honnef, D6570r00001, Alemanha, D6570R00001
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Bad Lippspringe, D6570r00001, Alemanha, D6570R00001
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Bad Reichenhall, D6570r00001, Alemanha, D6570R00001
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Bad Sachsa, D6570r00001, Alemanha, D6570R00001
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Bad Windsheim, D6570r00001, Alemanha, D6570R00001
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Bad Woerishofen, D6570r00001, Alemanha, D6570R00001
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Bamberg, D6570r00001, Alemanha, D6570R00001
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Beelitz-Heilstaetten, D6570r00001, Alemanha, D6570R00001
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Bergisch Gladbach, D6570r00001, Alemanha, D6570R00001
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Berlin, D6570r00001, Alemanha, D6570R00001
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Biberach, D6570r00001, Alemanha, D6570R00001
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Birkenwerder, D6570r00001, Alemanha, D6570R00001
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Bitterfeld-Wolfen, D6570r00001, Alemanha, D6570R00001
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Bochum, D6570r00001, Alemanha, D6570R00001
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Boehlen, D6570r00001, Alemanha, D6570R00001
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Bonn, D6570r00001, Alemanha, D6570R00001
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Bottrop, D6570r00001, Alemanha, D6570R00001
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Braunschweig, D6570r00001, Alemanha, D6570R00001
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Bruchsal, D6570r00001, Alemanha, D6570R00001
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Buechen, D6570r00001, Alemanha, D6570R00001
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Burghaslach, D6570r00001, Alemanha, D6570R00001
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Burgwedel, D6570r00001, Alemanha, D6570R00001
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Celle, D6570r00001, Alemanha, D6570R00001
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Chemnitz, D6570r00001, Alemanha, D6570R00001
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Cottbus, D6570r00001, Alemanha, D6570R00001
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Darmstadt, D6570r00001, Alemanha, D6570R00001
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Delitzsch, D6570r00001, Alemanha, D6570R00001
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Dessau, D6570r00001, Alemanha, D6570R00001
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Dorsten, D6570r00001, Alemanha, D6570R00001
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Dortmund, D6570r00001, Alemanha, D6570R00001
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Dresden, D6570r00001, Alemanha, D6570R00001
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Dueren, D6570r00001, Alemanha, D6570R00001
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Duesseldorf, D6570r00001, Alemanha, D6570R00001
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Duisburg, D6570r00001, Alemanha, D6570R00001
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Eimsheim, D6570r00001, Alemanha, D6570R00001
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Ellerstadt, D6570r00001, Alemanha, D6570R00001
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Elsterwerda, D6570r00001, Alemanha, D6570R00001
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Elterlein, D6570r00001, Alemanha, D6570R00001
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Essen, D6570r00001, Alemanha, D6570R00001
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Euerbach-Obbach, D6570r00001, Alemanha, D6570R00001
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Euskirchen, D6570r00001, Alemanha, D6570R00001
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Flensburg, D6570r00001, Alemanha, D6570R00001
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Frankfurt, D6570r00001, Alemanha, D6570R00001
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Frankfurt/M., D6570r00001, Alemanha, D6570R00001
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Freiberg, D6570r00001, Alemanha, D6570R00001
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Fuerstenwalde, D6570r00001, Alemanha, D6570R00001
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Fuerth, D6570r00001, Alemanha, D6570R00001
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Ganderkesee, D6570r00001, Alemanha, D6570R00001
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Garching, D6570r00001, Alemanha, D6570R00001
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Garmisch-Partenkirchen, D6570r00001, Alemanha, D6570R00001
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Gauting, D6570r00001, Alemanha, D6570R00001
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Gera, D6570r00001, Alemanha, D6570R00001
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Gerwisch, D6570r00001, Alemanha, D6570R00001
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Glienicke, D6570r00001, Alemanha, D6570R00001
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Greiz, D6570r00001, Alemanha, D6570R00001
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Guetersloh, D6570r00001, Alemanha, D6570R00001
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Hagen, D6570r00001, Alemanha, D6570R00001
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Halberstadt, D6570r00001, Alemanha, D6570R00001
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Halle, D6570r00001, Alemanha, D6570R00001
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Hamburg, D6570r00001, Alemanha, D6570R00001
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Hannover, D6570r00001, Alemanha, D6570R00001
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Hartenstein, D6570r00001, Alemanha, D6570R00001
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Heidelberg, D6570r00001, Alemanha, D6570R00001
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Hemmingen, D6570r00001, Alemanha, D6570R00001
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Hettstedt, D6570r00001, Alemanha, D6570R00001
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Hoechstadt, D6570r00001, Alemanha, D6570R00001
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Hoyerswerda, D6570r00001, Alemanha, D6570R00001
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Ibbenbueren, D6570r00001, Alemanha, D6570R00001
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Ingolstadt, D6570r00001, Alemanha, D6570R00001
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Iserlohn, D6570r00001, Alemanha, D6570R00001
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Issum, D6570r00001, Alemanha, D6570R00001
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Jena, D6570r00001, Alemanha, D6570R00001
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Karlsruhe, D6570r00001, Alemanha, D6570R00001
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Kevelaer, D6570r00001, Alemanha, D6570R00001
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Kleve, D6570r00001, Alemanha, D6570R00001
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Koeln, D6570r00001, Alemanha, D6570R00001
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Koeln-Hoehenberg, D6570r00001, Alemanha, D6570R00001
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Koeln-Rodenkirchen, D6570r00001, Alemanha, D6570R00001
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Koethen, D6570r00001, Alemanha, D6570R00001
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Kolbermoor, D6570r00001, Alemanha, D6570R00001
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Krefeld, D6570r00001, Alemanha, D6570R00001
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Kronach, D6570r00001, Alemanha, D6570R00001
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Kyritz, D6570r00001, Alemanha, D6570R00001
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Langenfeld, D6570r00001, Alemanha, D6570R00001
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Leer, D6570r00001, Alemanha, D6570R00001
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Leipzig, D6570r00001, Alemanha, D6570R00001
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Leonberg, D6570r00001, Alemanha, D6570R00001
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Lippstadt, D6570r00001, Alemanha, D6570R00001
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Ludwigsburg-Ossweil, D6570r00001, Alemanha, D6570R00001
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Ludwigshafen, D6570r00001, Alemanha, D6570R00001
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Luebeck, D6570r00001, Alemanha, D6570R00001
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Magdeburg, D6570r00001, Alemanha, D6570R00001
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Mainz, D6570r00001, Alemanha, D6570R00001
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Mannheim, D6570r00001, Alemanha, D6570R00001
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Marburg, D6570r00001, Alemanha, D6570R00001
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Markt Bibart, D6570r00001, Alemanha, D6570R00001
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Menden, D6570r00001, Alemanha, D6570R00001
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Merzig, D6570r00001, Alemanha, D6570R00001
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Moenchengladbach, D6570r00001, Alemanha, D6570R00001
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Moers, D6570r00001, Alemanha, D6570R00001
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Monheim, D6570r00001, Alemanha, D6570R00001
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Mosbach, D6570r00001, Alemanha, D6570R00001
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Muehlhausen, D6570r00001, Alemanha, D6570R00001
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Muenchen, D6570r00001, Alemanha, D6570R00001
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Neumarkt, D6570r00001, Alemanha, D6570R00001
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Neunkirchen, D6570r00001, Alemanha, D6570R00001
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Neuruppin, D6570r00001, Alemanha, D6570R00001
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Neusaess, D6570r00001, Alemanha, D6570R00001
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Neustadt/Aisch, D6570r00001, Alemanha, D6570R00001
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Neuwied, D6570r00001, Alemanha, D6570R00001
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Nuernberg, D6570r00001, Alemanha, D6570R00001
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Oettingen, D6570r00001, Alemanha, D6570R00001
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Oschatz, D6570r00001, Alemanha, D6570R00001
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Oy-Mittelberg, D6570r00001, Alemanha, D6570R00001
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Pirmasens, D6570r00001, Alemanha, D6570R00001
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Potsdam, D6570r00001, Alemanha, D6570R00001
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Pulheim-Braunweiler, D6570r00001, Alemanha, D6570R00001
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Radebeul, D6570r00001, Alemanha, D6570R00001
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Rastatt, D6570r00001, Alemanha, D6570R00001
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Rathenow, D6570r00001, Alemanha, D6570R00001
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Recklinghausen, D6570r00001, Alemanha, D6570R00001
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Remscheid, D6570r00001, Alemanha, D6570R00001
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Reutlingen, D6570r00001, Alemanha, D6570R00001
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Rosenheim, D6570r00001, Alemanha, D6570R00001
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Rostock, D6570r00001, Alemanha, D6570R00001
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Roth, D6570r00001, Alemanha, D6570R00001
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Ruedersdorf, D6570r00001, Alemanha, D6570R00001
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Ruesselsheim, D6570r00001, Alemanha, D6570R00001
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Rust, D6570r00001, Alemanha, D6570R00001
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Saalfeld, D6570r00001, Alemanha, D6570R00001
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Saarbruecken, D6570r00001, Alemanha, D6570R00001
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Saarlouis, D6570r00001, Alemanha, D6570R00001
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Schleswig, D6570r00001, Alemanha, D6570R00001
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Schmoelln, D6570r00001, Alemanha, D6570R00001
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Schoenbrunn, D6570r00001, Alemanha, D6570R00001
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Schwedt, D6570r00001, Alemanha, D6570R00001
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Siegen, D6570r00001, Alemanha, D6570R00001
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Simmern, D6570r00001, Alemanha, D6570R00001
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Solingen, D6570r00001, Alemanha, D6570R00001
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Sonsbeck, D6570r00001, Alemanha, D6570R00001
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Spiesen, D6570r00001, Alemanha, D6570R00001
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Spremberg, D6570r00001, Alemanha, D6570R00001
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Steinhagen, D6570r00001, Alemanha, D6570R00001
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Strasskirchen, D6570r00001, Alemanha, D6570R00001
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Strausberg, D6570r00001, Alemanha, D6570R00001
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Stuttgart, D6570r00001, Alemanha, D6570R00001
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Sulzberg, D6570r00001, Alemanha, D6570R00001
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Teterow, D6570r00001, Alemanha, D6570R00001
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Teuchern, D6570r00001, Alemanha, D6570R00001
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Thaleischweiler-Froeschen, D6570r00001, Alemanha, D6570R00001
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Trier, D6570r00001, Alemanha, D6570R00001
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Ulm, D6570r00001, Alemanha, D6570R00001
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Unterwellenborn, D6570r00001, Alemanha, D6570R00001
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Ursensollen, D6570r00001, Alemanha, D6570R00001
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Voerde, D6570r00001, Alemanha, D6570R00001
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Wallenhorst, D6570r00001, Alemanha, D6570R00001
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Wardenburg, D6570r00001, Alemanha, D6570R00001
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Waren, D6570r00001, Alemanha, D6570R00001
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Warendorf, D6570r00001, Alemanha, D6570R00001
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Wehrheim, D6570r00001, Alemanha, D6570R00001
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Weilheim, D6570r00001, Alemanha, D6570R00001
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Weissenburg, D6570r00001, Alemanha, D6570R00001
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Weisswasser, D6570r00001, Alemanha, D6570R00001
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Wiesbaden, D6570r00001, Alemanha, D6570R00001
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Witten, D6570r00001, Alemanha, D6570R00001
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Wittenberg, D6570r00001, Alemanha, D6570R00001
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Worms, D6570r00001, Alemanha, D6570R00001
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Wuppertal, D6570r00001, Alemanha, D6570R00001
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Zwoenitz, D6570r00001, Alemanha, D6570R00001
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
40 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
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.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Lung function
Prazo: 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
Prazo: 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
Prazo: First visit (baseline)
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First visit (baseline)
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Number of patients with exacerbations within the previous 24 months
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in well-being and quality of life
Prazo: 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
Prazo: First visit (baseline) to end of observational period at 12 months
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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
Prazo: 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.
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First visit (baseline) to end of observational period at 12 months
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Lung function
Prazo: 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.
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First visit (baseline) to end of observational period at 12 months
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Number of exacerbations by grade
Prazo: First visit (baseline) to end of observational period at 12 months
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Number of exacerbations will be collected 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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Adverse events
Prazo: First visit (baseline) to end of observational period at 12 months
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Adverse events will be collected 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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Handling of inhaler
Prazo: At 12 months
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Questionnaire regarding handling of inhaler by patient
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At 12 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
24 de setembro de 2015
Conclusão Primária (Real)
31 de dezembro de 2017
Conclusão do estudo (Real)
31 de dezembro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
29 de julho de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
16 de setembro de 2015
Primeira postagem (Estimativa)
17 de setembro de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de dezembro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de dezembro de 2018
Última verificação
1 de dezembro de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- D6570R00001
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .