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

Completed

Conditions

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

Observational

Enrollment (Actual)

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

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

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
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

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

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

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)

September 24, 2015

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 10, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6570R00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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