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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| Lung function | Assessment of FEV1 (Forced Expiratory Volume), FVC (Forced Vital Capacity) | First visit (baseline) |
| Number of patients with concomitant diseases classified by diagnostic subgroups | First visit (baseline) | |
| Number of patients receiving concomitant COPD (Chronic obstructive pulmonary disease) medication classified by therapeutic subgroups | First visit (baseline) | |
| Number of patients with exacerbations within the previous 24 months | History of previous exacerbations that will be collected at first observational visit. | First visit (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in well-being and quality of life | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aachen | D6570r00001 | D6570R00001 | Germany | ||
| Research Site |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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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 | 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 | 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 | 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 | 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 | Questionnaire regarding handling of inhaler by patient | At 12 months |
| Aldenhofen |
| D6570r00001 |
| D6570R00001 |
| Germany |
| Research Site | Aldenhoven | D6570r00001 | D6570R00001 | Germany |
| Research Site | Alzey | D6570r00001 | D6570R00001 | Germany |
| Research Site | Ansbach | D6570r00001 | D6570R00001 | Germany |
| Research Site | Apolda | D6570r00001 | D6570R00001 | Germany |
| Research Site | Aschau | D6570r00001 | D6570R00001 | Germany |
| Research Site | Auerbach | D6570r00001 | D6570R00001 | Germany |
| Research Site | Augsburg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Bad Fallingbostel | D6570r00001 | D6570R00001 | Germany |
| Research Site | Bad Hersfeld | D6570r00001 | D6570R00001 | Germany |
| Research Site | Bad Honnef | D6570r00001 | D6570R00001 | Germany |
| Research Site | Bad Lippspringe | D6570r00001 | D6570R00001 | Germany |
| Research Site | Bad Reichenhall | D6570r00001 | D6570R00001 | Germany |
| Research Site | Bad Sachsa | D6570r00001 | D6570R00001 | Germany |
| Research Site | Bad Windsheim | D6570r00001 | D6570R00001 | Germany |
| Research Site | Bad Wörishofen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Bamberg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Beelitz-Heilstätten | D6570r00001 | D6570R00001 | Germany |
| Research Site | Bergisch Gladbach | D6570r00001 | D6570R00001 | Germany |
| Research Site | Berlin | D6570r00001 | D6570R00001 | Germany |
| Research Site | Biberach | D6570r00001 | D6570R00001 | Germany |
| Research Site | Birkenwerder | D6570r00001 | D6570R00001 | Germany |
| Research Site | Bitterfeld-Wolfen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Bochum | D6570r00001 | D6570R00001 | Germany |
| Research Site | Bonn | D6570r00001 | D6570R00001 | Germany |
| Research Site | Bottrop | D6570r00001 | D6570R00001 | Germany |
| Research Site | Böhlen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Braunschweig | D6570r00001 | D6570R00001 | Germany |
| Research Site | Bruchsal | D6570r00001 | D6570R00001 | Germany |
| Research Site | Burghaslach | D6570r00001 | D6570R00001 | Germany |
| Research Site | Burgwedel | D6570r00001 | D6570R00001 | Germany |
| Research Site | Büchen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Celle | D6570r00001 | D6570R00001 | Germany |
| Research Site | Chemnitz | D6570r00001 | D6570R00001 | Germany |
| Research Site | Cologne | D6570r00001 | D6570R00001 | Germany |
| Research Site | Cottbus | D6570r00001 | D6570R00001 | Germany |
| Research Site | Darmstadt | D6570r00001 | D6570R00001 | Germany |
| Research Site | Delitzsch | D6570r00001 | D6570R00001 | Germany |
| Research Site | Dessau | D6570r00001 | D6570R00001 | Germany |
| Research Site | Dorsten | D6570r00001 | D6570R00001 | Germany |
| Research Site | Dortmund | D6570r00001 | D6570R00001 | Germany |
| Research Site | Dresden | D6570r00001 | D6570R00001 | Germany |
| Research Site | Duisburg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Düren | D6570r00001 | D6570R00001 | Germany |
| Research Site | Düsseldorf | D6570r00001 | D6570R00001 | Germany |
| Research Site | Eimsheim | D6570r00001 | D6570R00001 | Germany |
| Research Site | Ellerstadt | D6570r00001 | D6570R00001 | Germany |
| Research Site | Elsterwerda | D6570r00001 | D6570R00001 | Germany |
| Research Site | Elterlein | D6570r00001 | D6570R00001 | Germany |
| Research Site | Essen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Euerbach-Obbach | D6570r00001 | D6570R00001 | Germany |
| Research Site | Euskirchen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Flensburg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Frankfurt | D6570r00001 | D6570R00001 | Germany |
| Research Site | Frankfurt/M. | D6570r00001 | D6570R00001 | Germany |
| Research Site | Freiberg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Fürstenwalde | D6570r00001 | D6570R00001 | Germany |
| Research Site | Fürth | D6570r00001 | D6570R00001 | Germany |
| Research Site | Ganderkesee | D6570r00001 | D6570R00001 | Germany |
| Research Site | Garching | D6570r00001 | D6570R00001 | Germany |
| Research Site | Garmisch-Partenkirchen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Gauting | D6570r00001 | D6570R00001 | Germany |
| Research Site | Gera | D6570r00001 | D6570R00001 | Germany |
| Research Site | Gerwisch | D6570r00001 | D6570R00001 | Germany |
| Research Site | Glienicke | D6570r00001 | D6570R00001 | Germany |
| Research Site | Greiz | D6570r00001 | D6570R00001 | Germany |
| Research Site | Gütersloh | D6570r00001 | D6570R00001 | Germany |
| Research Site | Hagen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Halberstadt | D6570r00001 | D6570R00001 | Germany |
| Research Site | Halle | D6570r00001 | D6570R00001 | Germany |
| Research Site | Hamburg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Hanover | D6570r00001 | D6570R00001 | Germany |
| Research Site | Hartenstein | D6570r00001 | D6570R00001 | Germany |
| Research Site | Heidelberg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Hemmingen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Hettstedt | D6570r00001 | D6570R00001 | Germany |
| Research Site | Hoyerswerda | D6570r00001 | D6570R00001 | Germany |
| Research Site | Höchstadt an der Aisch | D6570r00001 | D6570R00001 | Germany |
| Research Site | Ibbenbueren | D6570r00001 | D6570R00001 | Germany |
| Research Site | Ingolstadt | D6570r00001 | D6570R00001 | Germany |
| Research Site | Iserlohn | D6570r00001 | D6570R00001 | Germany |
| Research Site | Issum | D6570r00001 | D6570R00001 | Germany |
| Research Site | Jena | D6570r00001 | D6570R00001 | Germany |
| Research Site | Karlsruhe | D6570r00001 | D6570R00001 | Germany |
| Research Site | Kevelaer | D6570r00001 | D6570R00001 | Germany |
| Research Site | Kleve | D6570r00001 | D6570R00001 | Germany |
| Research Site | Koeln-Hoehenberg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Koeln-Rodenkirchen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Kolbermoor | D6570r00001 | D6570R00001 | Germany |
| Research Site | Köthen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Krefeld | D6570r00001 | D6570R00001 | Germany |
| Research Site | Kronach | D6570r00001 | D6570R00001 | Germany |
| Research Site | Kyritz | D6570r00001 | D6570R00001 | Germany |
| Research Site | Langenfeld | D6570r00001 | D6570R00001 | Germany |
| Research Site | Leer | D6570r00001 | D6570R00001 | Germany |
| Research Site | Leipzig | D6570r00001 | D6570R00001 | Germany |
| Research Site | Leonberg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Lippstadt | D6570r00001 | D6570R00001 | Germany |
| Research Site | Ludwigsburg-Ossweil | D6570r00001 | D6570R00001 | Germany |
| Research Site | Ludwigshafen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Lübeck | D6570r00001 | D6570R00001 | Germany |
| Research Site | Magdeburg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Mainz | D6570r00001 | D6570R00001 | Germany |
| Research Site | Mannheim | D6570r00001 | D6570R00001 | Germany |
| Research Site | Marburg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Markt Bibart | D6570r00001 | D6570R00001 | Germany |
| Research Site | Menden | D6570r00001 | D6570R00001 | Germany |
| Research Site | Merzig | D6570r00001 | D6570R00001 | Germany |
| Research Site | Moers | D6570r00001 | D6570R00001 | Germany |
| Research Site | Monheim | D6570r00001 | D6570R00001 | Germany |
| Research Site | Mosbach | D6570r00001 | D6570R00001 | Germany |
| Research Site | Mönchengladbach | D6570r00001 | D6570R00001 | Germany |
| Research Site | Mühlhausen | D6570r00001 | D6570R00001 | Germany |
| Research Site | München | D6570r00001 | D6570R00001 | Germany |
| Research Site | Neumarkt | D6570r00001 | D6570R00001 | Germany |
| Research Site | Neunkirchen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Neuruppin | D6570r00001 | D6570R00001 | Germany |
| Research Site | Neusäß | D6570r00001 | D6570R00001 | Germany |
| Research Site | Neustadt/Aisch | D6570r00001 | D6570R00001 | Germany |
| Research Site | Neuwied | D6570r00001 | D6570R00001 | Germany |
| Research Site | Nuremberg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Oettingen in Bayern | D6570r00001 | D6570R00001 | Germany |
| Research Site | Oschatz | D6570r00001 | D6570R00001 | Germany |
| Research Site | Oy-Mittelberg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Pirmasens | D6570r00001 | D6570R00001 | Germany |
| Research Site | Potsdam | D6570r00001 | D6570R00001 | Germany |
| Research Site | Pulheim-Braunweiler | D6570r00001 | D6570R00001 | Germany |
| Research Site | Radebeul | D6570r00001 | D6570R00001 | Germany |
| Research Site | Rastatt | D6570r00001 | D6570R00001 | Germany |
| Research Site | Rathenow | D6570r00001 | D6570R00001 | Germany |
| Research Site | Recklinghausen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Remscheid | D6570r00001 | D6570R00001 | Germany |
| Research Site | Reutlingen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Rosenheim | D6570r00001 | D6570R00001 | Germany |
| Research Site | Rostock | D6570r00001 | D6570R00001 | Germany |
| Research Site | Roth | D6570r00001 | D6570R00001 | Germany |
| Research Site | Rust | D6570r00001 | D6570R00001 | Germany |
| Research Site | Rüdersdorf | D6570r00001 | D6570R00001 | Germany |
| Research Site | Rüsselsheim am Main | D6570r00001 | D6570R00001 | Germany |
| Research Site | Saalfeld | D6570r00001 | D6570R00001 | Germany |
| Research Site | Saarbrücken | D6570r00001 | D6570R00001 | Germany |
| Research Site | Saarlouis | D6570r00001 | D6570R00001 | Germany |
| Research Site | Schleswig | D6570r00001 | D6570R00001 | Germany |
| Research Site | Schmölln | D6570r00001 | D6570R00001 | Germany |
| Research Site | Schönbrunn | D6570r00001 | D6570R00001 | Germany |
| Research Site | Schwedt | D6570r00001 | D6570R00001 | Germany |
| Research Site | Siegen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Simmern | D6570r00001 | D6570R00001 | Germany |
| Research Site | Solingen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Sonsbeck | D6570r00001 | D6570R00001 | Germany |
| Research Site | Spiesen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Spremberg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Steinhagen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Strausberg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Straßkirchen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Stuttgart | D6570r00001 | D6570R00001 | Germany |
| Research Site | Sulzberg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Teterow | D6570r00001 | D6570R00001 | Germany |
| Research Site | Teuchern | D6570r00001 | D6570R00001 | Germany |
| Research Site | Thaleischweiler-Fröschen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Trier | D6570r00001 | D6570R00001 | Germany |
| Research Site | Ulm | D6570r00001 | D6570R00001 | Germany |
| Research Site | Unterwellenborn | D6570r00001 | D6570R00001 | Germany |
| Research Site | Ursensollen | D6570r00001 | D6570R00001 | Germany |
| Research Site | Voerde | D6570r00001 | D6570R00001 | Germany |
| Research Site | Wallenhorst | D6570r00001 | D6570R00001 | Germany |
| Research Site | Wardenburg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Waren | D6570r00001 | D6570R00001 | Germany |
| Research Site | Warendorf | D6570r00001 | D6570R00001 | Germany |
| Research Site | Wehrheim | D6570r00001 | D6570R00001 | Germany |
| Research Site | Weilheim | D6570r00001 | D6570R00001 | Germany |
| Research Site | Weißenburg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Weißwasser | D6570r00001 | D6570R00001 | Germany |
| Research Site | Wiesbaden | D6570r00001 | D6570R00001 | Germany |
| Research Site | Witten | D6570r00001 | D6570R00001 | Germany |
| Research Site | Wittenberg | D6570r00001 | D6570R00001 | Germany |
| Research Site | Worms | D6570r00001 | D6570R00001 | Germany |
| Research Site | Wuppertal | D6570r00001 | D6570R00001 | Germany |
| Research Site | Zwönitz | D6570r00001 | D6570R00001 | Germany |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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