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DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy (DETECT)

10 de diciembre de 2018 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

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 estudio

De observación

Inscripción (Actual)

3732

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
    • D6570r00001
      • Aachen, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Aldenhofen, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Aldenhoven, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Alzey, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Ansbach, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Apolda, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Aschau, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Auerbach, D6570r00001, Alemania, D6570R00001
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      • Augsburg, D6570r00001, Alemania, D6570R00001
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      • Bad Fallingbostel, D6570r00001, Alemania, D6570R00001
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      • Bad Hersfeld, D6570r00001, Alemania, D6570R00001
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      • Bad Honnef, D6570r00001, Alemania, D6570R00001
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      • Bad Lippspringe, D6570r00001, Alemania, D6570R00001
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      • Bad Reichenhall, D6570r00001, Alemania, D6570R00001
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      • Bad Sachsa, D6570r00001, Alemania, D6570R00001
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      • Bad Windsheim, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Bad Woerishofen, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Bamberg, D6570r00001, Alemania, D6570R00001
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      • Beelitz-Heilstaetten, D6570r00001, Alemania, D6570R00001
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      • Bergisch Gladbach, D6570r00001, Alemania, D6570R00001
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      • Berlin, D6570r00001, Alemania, D6570R00001
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      • Biberach, D6570r00001, Alemania, D6570R00001
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      • Birkenwerder, D6570r00001, Alemania, D6570R00001
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      • Bitterfeld-Wolfen, D6570r00001, Alemania, D6570R00001
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      • Bochum, D6570r00001, Alemania, D6570R00001
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      • Boehlen, D6570r00001, Alemania, D6570R00001
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      • Bonn, D6570r00001, Alemania, D6570R00001
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      • Bottrop, D6570r00001, Alemania, D6570R00001
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      • Braunschweig, D6570r00001, Alemania, D6570R00001
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      • Bruchsal, D6570r00001, Alemania, D6570R00001
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      • Buechen, D6570r00001, Alemania, D6570R00001
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      • Burghaslach, D6570r00001, Alemania, D6570R00001
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      • Burgwedel, D6570r00001, Alemania, D6570R00001
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      • Celle, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Chemnitz, D6570r00001, Alemania, D6570R00001
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      • Cottbus, D6570r00001, Alemania, D6570R00001
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      • Darmstadt, D6570r00001, Alemania, D6570R00001
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      • Delitzsch, D6570r00001, Alemania, D6570R00001
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      • Dessau, D6570r00001, Alemania, D6570R00001
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      • Dorsten, D6570r00001, Alemania, D6570R00001
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      • Dortmund, D6570r00001, Alemania, D6570R00001
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      • Dresden, D6570r00001, Alemania, D6570R00001
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      • Dueren, D6570r00001, Alemania, D6570R00001
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      • Duesseldorf, D6570r00001, Alemania, D6570R00001
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      • Duisburg, D6570r00001, Alemania, D6570R00001
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      • Eimsheim, D6570r00001, Alemania, D6570R00001
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      • Ellerstadt, D6570r00001, Alemania, D6570R00001
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      • Elsterwerda, D6570r00001, Alemania, D6570R00001
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      • Elterlein, D6570r00001, Alemania, D6570R00001
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      • Essen, D6570r00001, Alemania, D6570R00001
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      • Euerbach-Obbach, D6570r00001, Alemania, D6570R00001
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      • Euskirchen, D6570r00001, Alemania, D6570R00001
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      • Flensburg, D6570r00001, Alemania, D6570R00001
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      • Frankfurt, D6570r00001, Alemania, D6570R00001
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      • Frankfurt/M., D6570r00001, Alemania, D6570R00001
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      • Freiberg, D6570r00001, Alemania, D6570R00001
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      • Fuerstenwalde, D6570r00001, Alemania, D6570R00001
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      • Fuerth, D6570r00001, Alemania, D6570R00001
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      • Ganderkesee, D6570r00001, Alemania, D6570R00001
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      • Garching, D6570r00001, Alemania, D6570R00001
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      • Garmisch-Partenkirchen, D6570r00001, Alemania, D6570R00001
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      • Gauting, D6570r00001, Alemania, D6570R00001
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      • Gera, D6570r00001, Alemania, D6570R00001
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      • Gerwisch, D6570r00001, Alemania, D6570R00001
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      • Glienicke, D6570r00001, Alemania, D6570R00001
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      • Greiz, D6570r00001, Alemania, D6570R00001
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      • Guetersloh, D6570r00001, Alemania, D6570R00001
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      • Hagen, D6570r00001, Alemania, D6570R00001
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      • Halberstadt, D6570r00001, Alemania, D6570R00001
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      • Halle, D6570r00001, Alemania, D6570R00001
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      • Hamburg, D6570r00001, Alemania, D6570R00001
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      • Hannover, D6570r00001, Alemania, D6570R00001
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      • Hartenstein, D6570r00001, Alemania, D6570R00001
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      • Heidelberg, D6570r00001, Alemania, D6570R00001
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      • Hemmingen, D6570r00001, Alemania, D6570R00001
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      • Hettstedt, D6570r00001, Alemania, D6570R00001
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      • Hoechstadt, D6570r00001, Alemania, D6570R00001
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      • Hoyerswerda, D6570r00001, Alemania, D6570R00001
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      • Ibbenbueren, D6570r00001, Alemania, D6570R00001
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      • Ingolstadt, D6570r00001, Alemania, D6570R00001
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      • Iserlohn, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Issum, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Jena, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Karlsruhe, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Kevelaer, D6570r00001, Alemania, D6570R00001
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      • Kleve, D6570r00001, Alemania, D6570R00001
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      • Koeln, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Koeln-Hoehenberg, D6570r00001, Alemania, D6570R00001
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      • Koeln-Rodenkirchen, D6570r00001, Alemania, D6570R00001
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      • Koethen, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Kolbermoor, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Krefeld, D6570r00001, Alemania, D6570R00001
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      • Kronach, D6570r00001, Alemania, D6570R00001
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      • Kyritz, D6570r00001, Alemania, D6570R00001
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      • Langenfeld, D6570r00001, Alemania, D6570R00001
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      • Leer, D6570r00001, Alemania, D6570R00001
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      • Leipzig, D6570r00001, Alemania, D6570R00001
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      • Leonberg, D6570r00001, Alemania, D6570R00001
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      • Lippstadt, D6570r00001, Alemania, D6570R00001
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      • Ludwigsburg-Ossweil, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Ludwigshafen, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Luebeck, D6570r00001, Alemania, D6570R00001
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      • Magdeburg, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Mainz, D6570r00001, Alemania, D6570R00001
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      • Mannheim, D6570r00001, Alemania, D6570R00001
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      • Marburg, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Markt Bibart, D6570r00001, Alemania, D6570R00001
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      • Menden, D6570r00001, Alemania, D6570R00001
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      • Merzig, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Moenchengladbach, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Moers, D6570r00001, Alemania, D6570R00001
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      • Monheim, D6570r00001, Alemania, D6570R00001
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      • Mosbach, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Muehlhausen, D6570r00001, Alemania, D6570R00001
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      • Muenchen, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Neumarkt, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Neunkirchen, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Neuruppin, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Neusaess, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Neustadt/Aisch, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Neuwied, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Nuernberg, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Oettingen, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Oschatz, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Oy-Mittelberg, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Pirmasens, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Potsdam, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Pulheim-Braunweiler, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Radebeul, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Rastatt, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Rathenow, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Recklinghausen, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Remscheid, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Reutlingen, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Rosenheim, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Rostock, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Roth, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Ruedersdorf, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Ruesselsheim, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Rust, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Saalfeld, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Saarbruecken, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Saarlouis, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Schleswig, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Schmoelln, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Schoenbrunn, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Schwedt, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Siegen, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Simmern, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Solingen, D6570r00001, Alemania, D6570R00001
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      • Sonsbeck, D6570r00001, Alemania, D6570R00001
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      • Spiesen, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Spremberg, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Steinhagen, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Strasskirchen, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Strausberg, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Stuttgart, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Sulzberg, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Teterow, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Teuchern, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Thaleischweiler-Froeschen, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Trier, D6570r00001, Alemania, D6570R00001
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      • Ulm, D6570r00001, Alemania, D6570R00001
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      • Unterwellenborn, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Ursensollen, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Voerde, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Wallenhorst, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Wardenburg, D6570r00001, Alemania, D6570R00001
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      • Waren, D6570r00001, Alemania, D6570R00001
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      • Warendorf, D6570r00001, Alemania, D6570R00001
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      • Wehrheim, D6570r00001, Alemania, D6570R00001
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      • Weilheim, D6570r00001, Alemania, D6570R00001
        • Research Site
      • Weissenburg, D6570r00001, Alemania, D6570R00001
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      • Weisswasser, D6570r00001, Alemania, D6570R00001
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      • Wiesbaden, D6570r00001, Alemania, D6570R00001
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      • Witten, D6570r00001, Alemania, D6570R00001
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      • Wittenberg, D6570r00001, Alemania, D6570R00001
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      • Worms, D6570r00001, Alemania, D6570R00001
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      • Wuppertal, D6570r00001, Alemania, D6570R00001
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      • Zwoenitz, D6570r00001, Alemania, D6570R00001
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Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

40 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Patients on Duaklir® Genuair®
Patients on fixed-dose combination Duaklir® Genuair® (Aclidinium/Formoterol)
Patients on Ultibro® Breezhaler®
Patients on fixed-dose combination Ultibro® Breezhaler® (Glycopyrronium/Indacaterol)
Patients on Anoro®
Patients on fixed-dose combination Anoro® (Umeclidinium/Vilanterol)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Lung function
Periodo de tiempo: First visit (baseline)
Assessment of FEV1 (Forced Expiratory Volume), FVC (Forced Vital Capacity)
First visit (baseline)
Number of patients with concomitant diseases classified by diagnostic subgroups
Periodo de tiempo: First visit (baseline)
First visit (baseline)
Number of patients receiving concomitant COPD (Chronic obstructive pulmonary disease) medication classified by therapeutic subgroups
Periodo de tiempo: First visit (baseline)
First visit (baseline)
Number of patients with exacerbations within the previous 24 months
Periodo de tiempo: First visit (baseline)
History of previous exacerbations that will be collected at first observational visit.
First visit (baseline)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in well-being and quality of life
Periodo de tiempo: First visit (baseline) to end of observational period at 12 months
CAT (COPD Assessment Test™) questionnaire will be completed at each visit, approximately every 3 months.
First visit (baseline) to end of observational period at 12 months
Effect on the severity of the shortness of breath
Periodo de tiempo: 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.
First visit (baseline) to end of observational period at 12 months
Change in the night-time and early-morning COPD symptoms
Periodo de tiempo: First visit (baseline) to end of observational period at 12 months
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
Lung function
Periodo de tiempo: First visit (baseline) to end of observational period at 12 months
Assessment of FEV1, FVC at each visit, approximately every 3 months.
First visit (baseline) to end of observational period at 12 months
Number of exacerbations by grade
Periodo de tiempo: 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
Adverse events
Periodo de tiempo: 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
Periodo de tiempo: At 12 months
Questionnaire regarding handling of inhaler by patient
At 12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AstraZeneca

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

24 de septiembre de 2015

Finalización primaria (Actual)

31 de diciembre de 2017

Finalización del estudio (Actual)

31 de diciembre de 2017

Fechas de registro del estudio

Enviado por primera vez

29 de julio de 2015

Primero enviado que cumplió con los criterios de control de calidad

16 de septiembre de 2015

Publicado por primera vez (Estimar)

17 de septiembre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de diciembre de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

10 de diciembre de 2018

Última verificación

1 de diciembre de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • D6570R00001

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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