DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy

NCT02552160 | Completed

• 1 other identifier: D6570R00001
• Study Type: observational
• Target: 3,732
• Locations: 1 country
• Sites: 180

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Fixed-dose Combination; LAMA/LABA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists); Inhaler; Aclidinium/Formoterol; Glycopyrronium/Indacaterol; Umeclidinium/Vilanterol

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (7)

• Change in well-being and quality of life

  First visit (baseline) to end of observational period at 12 months

• Effect on the severity of the shortness of breath

  First visit (baseline) to end of observational period at 12 months

• Change in the night-time and early-morning COPD symptoms

  First visit (baseline) to end of observational period at 12 months

• Lung function

  First visit (baseline) to end of observational period at 12 months

• Number of exacerbations by grade

  First visit (baseline) to end of observational period at 12 months

Study Arms (3)

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)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (180)

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Aachen, D6570r00001, D6570R00001, Germany

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Aldenhofen, D6570r00001, D6570R00001, Germany

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Aldenhoven, D6570r00001, D6570R00001, Germany

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Alzey, D6570r00001, D6570R00001, Germany

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Ansbach, D6570r00001, D6570R00001, Germany

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Apolda, D6570r00001, D6570R00001, Germany

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Aschau, D6570r00001, D6570R00001, Germany

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Auerbach, D6570r00001, D6570R00001, Germany

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Augsburg, D6570r00001, D6570R00001, Germany

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Bad Fallingbostel, D6570r00001, D6570R00001, Germany

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Bad Hersfeld, D6570r00001, D6570R00001, Germany

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Bad Honnef, D6570r00001, D6570R00001, Germany

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Bad Lippspringe, D6570r00001, D6570R00001, Germany

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Bad Reichenhall, D6570r00001, D6570R00001, Germany

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Bad Sachsa, D6570r00001, D6570R00001, Germany

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Bad Windsheim, D6570r00001, D6570R00001, Germany

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Bad Wörishofen, D6570r00001, D6570R00001, Germany

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Bamberg, D6570r00001, D6570R00001, Germany

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Beelitz-Heilstätten, D6570r00001, D6570R00001, Germany

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Bergisch Gladbach, D6570r00001, D6570R00001, Germany

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Berlin, D6570r00001, D6570R00001, Germany

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Biberach, D6570r00001, D6570R00001, Germany

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Birkenwerder, D6570r00001, D6570R00001, Germany

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Bitterfeld-Wolfen, D6570r00001, D6570R00001, Germany

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Bochum, D6570r00001, D6570R00001, Germany

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Bonn, D6570r00001, D6570R00001, Germany

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Bottrop, D6570r00001, D6570R00001, Germany

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Böhlen, D6570r00001, D6570R00001, Germany

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Braunschweig, D6570r00001, D6570R00001, Germany

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Bruchsal, D6570r00001, D6570R00001, Germany

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Burghaslach, D6570r00001, D6570R00001, Germany

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Burgwedel, D6570r00001, D6570R00001, Germany

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Büchen, D6570r00001, D6570R00001, Germany

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Celle, D6570r00001, D6570R00001, Germany

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Chemnitz, D6570r00001, D6570R00001, Germany

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Cologne, D6570r00001, D6570R00001, Germany

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Cottbus, D6570r00001, D6570R00001, Germany

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Darmstadt, D6570r00001, D6570R00001, Germany

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Delitzsch, D6570r00001, D6570R00001, Germany

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Dessau, D6570r00001, D6570R00001, Germany

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Dorsten, D6570r00001, D6570R00001, Germany

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Dortmund, D6570r00001, D6570R00001, Germany

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Dresden, D6570r00001, D6570R00001, Germany

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Duisburg, D6570r00001, D6570R00001, Germany

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Düren, D6570r00001, D6570R00001, Germany

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Düsseldorf, D6570r00001, D6570R00001, Germany

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Eimsheim, D6570r00001, D6570R00001, Germany

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Ellerstadt, D6570r00001, D6570R00001, Germany

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Elsterwerda, D6570r00001, D6570R00001, Germany

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Elterlein, D6570r00001, D6570R00001, Germany

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Essen, D6570r00001, D6570R00001, Germany

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Euerbach-Obbach, D6570r00001, D6570R00001, Germany

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Euskirchen, D6570r00001, D6570R00001, Germany

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Flensburg, D6570r00001, D6570R00001, Germany

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Frankfurt, D6570r00001, D6570R00001, Germany

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Frankfurt/M., D6570r00001, D6570R00001, Germany

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Freiberg, D6570r00001, D6570R00001, Germany

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Fürstenwalde, D6570r00001, D6570R00001, Germany

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Fürth, D6570r00001, D6570R00001, Germany

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Ganderkesee, D6570r00001, D6570R00001, Germany

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Garching, D6570r00001, D6570R00001, Germany

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Garmisch-Partenkirchen, D6570r00001, D6570R00001, Germany

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Gauting, D6570r00001, D6570R00001, Germany

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Gera, D6570r00001, D6570R00001, Germany

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Gerwisch, D6570r00001, D6570R00001, Germany

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Glienicke, D6570r00001, D6570R00001, Germany

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Greiz, D6570r00001, D6570R00001, Germany

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Gütersloh, D6570r00001, D6570R00001, Germany

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Hagen, D6570r00001, D6570R00001, Germany

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Halberstadt, D6570r00001, D6570R00001, Germany

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Halle, D6570r00001, D6570R00001, Germany

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Hamburg, D6570r00001, D6570R00001, Germany

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Hanover, D6570r00001, D6570R00001, Germany

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Hartenstein, D6570r00001, D6570R00001, Germany

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Heidelberg, D6570r00001, D6570R00001, Germany

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Hemmingen, D6570r00001, D6570R00001, Germany

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Hettstedt, D6570r00001, D6570R00001, Germany

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Hoyerswerda, D6570r00001, D6570R00001, Germany

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Höchstadt an der Aisch, D6570r00001, D6570R00001, Germany

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Ibbenbueren, D6570r00001, D6570R00001, Germany

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Ingolstadt, D6570r00001, D6570R00001, Germany

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Iserlohn, D6570r00001, D6570R00001, Germany

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Issum, D6570r00001, D6570R00001, Germany

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Jena, D6570r00001, D6570R00001, Germany

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Karlsruhe, D6570r00001, D6570R00001, Germany

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Kevelaer, D6570r00001, D6570R00001, Germany

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Kleve, D6570r00001, D6570R00001, Germany

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Koeln-Hoehenberg, D6570r00001, D6570R00001, Germany

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Koeln-Rodenkirchen, D6570r00001, D6570R00001, Germany

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Kolbermoor, D6570r00001, D6570R00001, Germany

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Köthen, D6570r00001, D6570R00001, Germany

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Krefeld, D6570r00001, D6570R00001, Germany

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Kronach, D6570r00001, D6570R00001, Germany

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Kyritz, D6570r00001, D6570R00001, Germany

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Langenfeld, D6570r00001, D6570R00001, Germany

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Leer, D6570r00001, D6570R00001, Germany

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Leipzig, D6570r00001, D6570R00001, Germany

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Leonberg, D6570r00001, D6570R00001, Germany

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Lippstadt, D6570r00001, D6570R00001, Germany

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Ludwigsburg-Ossweil, D6570r00001, D6570R00001, Germany

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Ludwigshafen, D6570r00001, D6570R00001, Germany

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Lübeck, D6570r00001, D6570R00001, Germany

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Magdeburg, D6570r00001, D6570R00001, Germany

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Mainz, D6570r00001, D6570R00001, Germany

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Mannheim, D6570r00001, D6570R00001, Germany

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Marburg, D6570r00001, D6570R00001, Germany

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Markt Bibart, D6570r00001, D6570R00001, Germany

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Menden, D6570r00001, D6570R00001, Germany

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Merzig, D6570r00001, D6570R00001, Germany

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Moers, D6570r00001, D6570R00001, Germany

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Monheim, D6570r00001, D6570R00001, Germany

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Mosbach, D6570r00001, D6570R00001, Germany

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Mönchengladbach, D6570r00001, D6570R00001, Germany

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Mühlhausen, D6570r00001, D6570R00001, Germany

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München, D6570r00001, D6570R00001, Germany

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Neumarkt, D6570r00001, D6570R00001, Germany

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Neunkirchen, D6570r00001, D6570R00001, Germany

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Neuruppin, D6570r00001, D6570R00001, Germany

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Neusäß, D6570r00001, D6570R00001, Germany

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Neustadt/Aisch, D6570r00001, D6570R00001, Germany

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Neuwied, D6570r00001, D6570R00001, Germany

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Nuremberg, D6570r00001, D6570R00001, Germany

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Oettingen in Bayern, D6570r00001, D6570R00001, Germany

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Oschatz, D6570r00001, D6570R00001, Germany

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Oy-Mittelberg, D6570r00001, D6570R00001, Germany

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Pirmasens, D6570r00001, D6570R00001, Germany

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Potsdam, D6570r00001, D6570R00001, Germany

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Pulheim-Braunweiler, D6570r00001, D6570R00001, Germany

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Radebeul, D6570r00001, D6570R00001, Germany

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Rastatt, D6570r00001, D6570R00001, Germany

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Rathenow, D6570r00001, D6570R00001, Germany

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Recklinghausen, D6570r00001, D6570R00001, Germany

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Remscheid, D6570r00001, D6570R00001, Germany

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Reutlingen, D6570r00001, D6570R00001, Germany

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Rosenheim, D6570r00001, D6570R00001, Germany

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Rostock, D6570r00001, D6570R00001, Germany

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Roth, D6570r00001, D6570R00001, Germany

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Rust, D6570r00001, D6570R00001, Germany

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Rüdersdorf, D6570r00001, D6570R00001, Germany

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Rüsselsheim am Main, D6570r00001, D6570R00001, Germany

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Saalfeld, D6570r00001, D6570R00001, Germany

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Saarbrücken, D6570r00001, D6570R00001, Germany

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Saarlouis, D6570r00001, D6570R00001, Germany

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Schleswig, D6570r00001, D6570R00001, Germany

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Schmölln, D6570r00001, D6570R00001, Germany

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Schönbrunn, D6570r00001, D6570R00001, Germany

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Schwedt, D6570r00001, D6570R00001, Germany

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Siegen, D6570r00001, D6570R00001, Germany

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Simmern, D6570r00001, D6570R00001, Germany

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Solingen, D6570r00001, D6570R00001, Germany

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Sonsbeck, D6570r00001, D6570R00001, Germany

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Spiesen, D6570r00001, D6570R00001, Germany

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Spremberg, D6570r00001, D6570R00001, Germany

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Steinhagen, D6570r00001, D6570R00001, Germany

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Strausberg, D6570r00001, D6570R00001, Germany

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Straßkirchen, D6570r00001, D6570R00001, Germany

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Stuttgart, D6570r00001, D6570R00001, Germany

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Sulzberg, D6570r00001, D6570R00001, Germany

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Teterow, D6570r00001, D6570R00001, Germany

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Teuchern, D6570r00001, D6570R00001, Germany

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Thaleischweiler-Fröschen, D6570r00001, D6570R00001, Germany

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Trier, D6570r00001, D6570R00001, Germany

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Ulm, D6570r00001, D6570R00001, Germany

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Unterwellenborn, D6570r00001, D6570R00001, Germany

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Ursensollen, D6570r00001, D6570R00001, Germany

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Voerde, D6570r00001, D6570R00001, Germany

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Wallenhorst, D6570r00001, D6570R00001, Germany

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Wardenburg, D6570r00001, D6570R00001, Germany

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Waren, D6570r00001, D6570R00001, Germany

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Warendorf, D6570r00001, D6570R00001, Germany

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Wehrheim, D6570r00001, D6570R00001, Germany

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Weilheim, D6570r00001, D6570R00001, Germany

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Weißenburg, D6570r00001, D6570R00001, Germany

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Weißwasser, D6570r00001, D6570R00001, Germany

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Wiesbaden, D6570r00001, D6570R00001, Germany

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Witten, D6570r00001, D6570R00001, Germany

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Wittenberg, D6570r00001, D6570R00001, Germany

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Worms, D6570r00001, D6570R00001, Germany

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Wuppertal, D6570r00001, D6570R00001, Germany

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Zwönitz, D6570r00001, D6570R00001, Germany

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Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: September 17, 2015
• Study Start: September 24, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

DE (180)