DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy (DETECT)
10 dicembre 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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 di studio
Osservativo
Iscrizione (Effettivo)
3732
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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D6570r00001
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Aachen, D6570r00001, Germania, D6570R00001
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Aldenhofen, D6570r00001, Germania, D6570R00001
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Aldenhoven, D6570r00001, Germania, D6570R00001
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Alzey, D6570r00001, Germania, D6570R00001
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Ansbach, D6570r00001, Germania, D6570R00001
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Apolda, D6570r00001, Germania, D6570R00001
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Aschau, D6570r00001, Germania, D6570R00001
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Auerbach, D6570r00001, Germania, D6570R00001
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Augsburg, D6570r00001, Germania, D6570R00001
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Bad Fallingbostel, D6570r00001, Germania, D6570R00001
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Bad Hersfeld, D6570r00001, Germania, D6570R00001
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Bad Honnef, D6570r00001, Germania, D6570R00001
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Bad Lippspringe, D6570r00001, Germania, D6570R00001
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Bad Reichenhall, D6570r00001, Germania, D6570R00001
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Bad Sachsa, D6570r00001, Germania, D6570R00001
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Bad Windsheim, D6570r00001, Germania, D6570R00001
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Bad Woerishofen, D6570r00001, Germania, D6570R00001
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Bamberg, D6570r00001, Germania, D6570R00001
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Beelitz-Heilstaetten, D6570r00001, Germania, D6570R00001
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Bergisch Gladbach, D6570r00001, Germania, D6570R00001
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Berlin, D6570r00001, Germania, D6570R00001
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Biberach, D6570r00001, Germania, D6570R00001
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Birkenwerder, D6570r00001, Germania, D6570R00001
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Bitterfeld-Wolfen, D6570r00001, Germania, D6570R00001
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Bochum, D6570r00001, Germania, D6570R00001
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Boehlen, D6570r00001, Germania, D6570R00001
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Bonn, D6570r00001, Germania, D6570R00001
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Bottrop, D6570r00001, Germania, D6570R00001
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Braunschweig, D6570r00001, Germania, D6570R00001
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Bruchsal, D6570r00001, Germania, D6570R00001
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Buechen, D6570r00001, Germania, D6570R00001
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Burghaslach, D6570r00001, Germania, D6570R00001
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Burgwedel, D6570r00001, Germania, D6570R00001
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Celle, D6570r00001, Germania, D6570R00001
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Chemnitz, D6570r00001, Germania, D6570R00001
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Cottbus, D6570r00001, Germania, D6570R00001
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Darmstadt, D6570r00001, Germania, D6570R00001
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Delitzsch, D6570r00001, Germania, D6570R00001
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Dessau, D6570r00001, Germania, D6570R00001
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Dorsten, D6570r00001, Germania, D6570R00001
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Dortmund, D6570r00001, Germania, D6570R00001
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Dresden, D6570r00001, Germania, D6570R00001
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Dueren, D6570r00001, Germania, D6570R00001
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Duesseldorf, D6570r00001, Germania, D6570R00001
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Duisburg, D6570r00001, Germania, D6570R00001
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Eimsheim, D6570r00001, Germania, D6570R00001
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Ellerstadt, D6570r00001, Germania, D6570R00001
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Elsterwerda, D6570r00001, Germania, D6570R00001
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Elterlein, D6570r00001, Germania, D6570R00001
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Essen, D6570r00001, Germania, D6570R00001
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Euerbach-Obbach, D6570r00001, Germania, D6570R00001
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Euskirchen, D6570r00001, Germania, D6570R00001
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Flensburg, D6570r00001, Germania, D6570R00001
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Frankfurt, D6570r00001, Germania, D6570R00001
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Frankfurt/M., D6570r00001, Germania, D6570R00001
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Freiberg, D6570r00001, Germania, D6570R00001
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Fuerstenwalde, D6570r00001, Germania, D6570R00001
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Fuerth, D6570r00001, Germania, D6570R00001
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Ganderkesee, D6570r00001, Germania, D6570R00001
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Garching, D6570r00001, Germania, D6570R00001
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Garmisch-Partenkirchen, D6570r00001, Germania, D6570R00001
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Gauting, D6570r00001, Germania, D6570R00001
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Gera, D6570r00001, Germania, D6570R00001
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Gerwisch, D6570r00001, Germania, D6570R00001
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Glienicke, D6570r00001, Germania, D6570R00001
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Greiz, D6570r00001, Germania, D6570R00001
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Guetersloh, D6570r00001, Germania, D6570R00001
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Hagen, D6570r00001, Germania, D6570R00001
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Halberstadt, D6570r00001, Germania, D6570R00001
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Halle, D6570r00001, Germania, D6570R00001
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Hamburg, D6570r00001, Germania, D6570R00001
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Hannover, D6570r00001, Germania, D6570R00001
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Hartenstein, D6570r00001, Germania, D6570R00001
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Heidelberg, D6570r00001, Germania, D6570R00001
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Hemmingen, D6570r00001, Germania, D6570R00001
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Hettstedt, D6570r00001, Germania, D6570R00001
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Hoechstadt, D6570r00001, Germania, D6570R00001
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Hoyerswerda, D6570r00001, Germania, D6570R00001
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Ibbenbueren, D6570r00001, Germania, D6570R00001
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Ingolstadt, D6570r00001, Germania, D6570R00001
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Iserlohn, D6570r00001, Germania, D6570R00001
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Issum, D6570r00001, Germania, D6570R00001
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Jena, D6570r00001, Germania, D6570R00001
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Karlsruhe, D6570r00001, Germania, D6570R00001
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Kevelaer, D6570r00001, Germania, D6570R00001
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Kleve, D6570r00001, Germania, D6570R00001
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Koeln, D6570r00001, Germania, D6570R00001
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Koeln-Hoehenberg, D6570r00001, Germania, D6570R00001
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Koeln-Rodenkirchen, D6570r00001, Germania, D6570R00001
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Koethen, D6570r00001, Germania, D6570R00001
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Kolbermoor, D6570r00001, Germania, D6570R00001
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Krefeld, D6570r00001, Germania, D6570R00001
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Kronach, D6570r00001, Germania, D6570R00001
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Kyritz, D6570r00001, Germania, D6570R00001
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Langenfeld, D6570r00001, Germania, D6570R00001
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Leer, D6570r00001, Germania, D6570R00001
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Leipzig, D6570r00001, Germania, D6570R00001
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Leonberg, D6570r00001, Germania, D6570R00001
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Lippstadt, D6570r00001, Germania, D6570R00001
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Ludwigsburg-Ossweil, D6570r00001, Germania, D6570R00001
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Ludwigshafen, D6570r00001, Germania, D6570R00001
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Luebeck, D6570r00001, Germania, D6570R00001
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Magdeburg, D6570r00001, Germania, D6570R00001
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Mainz, D6570r00001, Germania, D6570R00001
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Mannheim, D6570r00001, Germania, D6570R00001
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Marburg, D6570r00001, Germania, D6570R00001
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Markt Bibart, D6570r00001, Germania, D6570R00001
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Menden, D6570r00001, Germania, D6570R00001
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Merzig, D6570r00001, Germania, D6570R00001
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Moenchengladbach, D6570r00001, Germania, D6570R00001
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Moers, D6570r00001, Germania, D6570R00001
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Monheim, D6570r00001, Germania, D6570R00001
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Mosbach, D6570r00001, Germania, D6570R00001
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Muehlhausen, D6570r00001, Germania, D6570R00001
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Muenchen, D6570r00001, Germania, D6570R00001
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Neumarkt, D6570r00001, Germania, D6570R00001
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Neunkirchen, D6570r00001, Germania, D6570R00001
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Neuruppin, D6570r00001, Germania, D6570R00001
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Neusaess, D6570r00001, Germania, D6570R00001
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Neustadt/Aisch, D6570r00001, Germania, D6570R00001
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Neuwied, D6570r00001, Germania, D6570R00001
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Nuernberg, D6570r00001, Germania, D6570R00001
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Oettingen, D6570r00001, Germania, D6570R00001
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Oschatz, D6570r00001, Germania, D6570R00001
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Oy-Mittelberg, D6570r00001, Germania, D6570R00001
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Pirmasens, D6570r00001, Germania, D6570R00001
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Potsdam, D6570r00001, Germania, D6570R00001
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Pulheim-Braunweiler, D6570r00001, Germania, D6570R00001
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Radebeul, D6570r00001, Germania, D6570R00001
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Rastatt, D6570r00001, Germania, D6570R00001
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Rathenow, D6570r00001, Germania, D6570R00001
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Recklinghausen, D6570r00001, Germania, D6570R00001
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Remscheid, D6570r00001, Germania, D6570R00001
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Reutlingen, D6570r00001, Germania, D6570R00001
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Rosenheim, D6570r00001, Germania, D6570R00001
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Rostock, D6570r00001, Germania, D6570R00001
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Roth, D6570r00001, Germania, D6570R00001
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Ruedersdorf, D6570r00001, Germania, D6570R00001
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Ruesselsheim, D6570r00001, Germania, D6570R00001
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Rust, D6570r00001, Germania, D6570R00001
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Saalfeld, D6570r00001, Germania, D6570R00001
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Saarbruecken, D6570r00001, Germania, D6570R00001
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Saarlouis, D6570r00001, Germania, D6570R00001
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Schleswig, D6570r00001, Germania, D6570R00001
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Schmoelln, D6570r00001, Germania, D6570R00001
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Schoenbrunn, D6570r00001, Germania, D6570R00001
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Schwedt, D6570r00001, Germania, D6570R00001
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Siegen, D6570r00001, Germania, D6570R00001
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Simmern, D6570r00001, Germania, D6570R00001
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Solingen, D6570r00001, Germania, D6570R00001
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Sonsbeck, D6570r00001, Germania, D6570R00001
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Spiesen, D6570r00001, Germania, D6570R00001
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Spremberg, D6570r00001, Germania, D6570R00001
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Steinhagen, D6570r00001, Germania, D6570R00001
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Strasskirchen, D6570r00001, Germania, D6570R00001
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Strausberg, D6570r00001, Germania, D6570R00001
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Stuttgart, D6570r00001, Germania, D6570R00001
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Sulzberg, D6570r00001, Germania, D6570R00001
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Teterow, D6570r00001, Germania, D6570R00001
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Teuchern, D6570r00001, Germania, D6570R00001
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Thaleischweiler-Froeschen, D6570r00001, Germania, D6570R00001
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Trier, D6570r00001, Germania, D6570R00001
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Ulm, D6570r00001, Germania, D6570R00001
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Unterwellenborn, D6570r00001, Germania, D6570R00001
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Ursensollen, D6570r00001, Germania, D6570R00001
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Voerde, D6570r00001, Germania, D6570R00001
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Wallenhorst, D6570r00001, Germania, D6570R00001
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Wardenburg, D6570r00001, Germania, D6570R00001
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Waren, D6570r00001, Germania, D6570R00001
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Warendorf, D6570r00001, Germania, D6570R00001
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Wehrheim, D6570r00001, Germania, D6570R00001
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Weilheim, D6570r00001, Germania, D6570R00001
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Weissenburg, D6570r00001, Germania, D6570R00001
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Weisswasser, D6570r00001, Germania, D6570R00001
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Wiesbaden, D6570r00001, Germania, D6570R00001
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Witten, D6570r00001, Germania, D6570R00001
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Wittenberg, D6570r00001, Germania, D6570R00001
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Worms, D6570r00001, Germania, D6570R00001
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Wuppertal, D6570r00001, Germania, D6570R00001
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Zwoenitz, D6570r00001, Germania, D6570R00001
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
40 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Lung function
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: First visit (baseline)
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First visit (baseline)
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Number of patients with exacerbations within the previous 24 months
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in well-being and quality of life
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
24 settembre 2015
Completamento primario (Effettivo)
31 dicembre 2017
Completamento dello studio (Effettivo)
31 dicembre 2017
Date di iscrizione allo studio
Primo inviato
29 luglio 2015
Primo inviato che soddisfa i criteri di controllo qualità
16 settembre 2015
Primo Inserito (Stima)
17 settembre 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 dicembre 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 dicembre 2018
Ultimo verificato
1 dicembre 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- D6570R00001
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .