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

December 10, 2018 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3732

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lung function
Time Frame: 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
Time Frame: First visit (baseline)
First visit (baseline)
Number of patients receiving concomitant COPD (Chronic obstructive pulmonary disease) medication classified by therapeutic subgroups
Time Frame: First visit (baseline)
First visit (baseline)
Number of patients with exacerbations within the previous 24 months
Time Frame: First visit (baseline)
History of previous exacerbations that will be collected at first observational visit.
First visit (baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in well-being and quality of life
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: At 12 months
Questionnaire regarding handling of inhaler by patient
At 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 24, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D6570R00001

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