DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy (DETECT)
10. december 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
3732
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
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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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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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|
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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 |
Foranstaltningsbeskrivelse |
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.
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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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
24. september 2015
Primær færdiggørelse (Faktiske)
31. december 2017
Studieafslutning (Faktiske)
31. december 2017
Datoer for studieregistrering
Først indsendt
29. juli 2015
Først indsendt, der opfyldte QC-kriterier
16. september 2015
Først opslået (Skøn)
17. september 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. december 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. december 2018
Sidst verificeret
1. december 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D6570R00001
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