Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis, Utilisation of Health Care Resources in Patients With COPD (COSYCONET)

April 11, 2024 updated by: Claus Vogelmeier, Philipps University Marburg Medical Center

Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis and Utilisation of Health Care Resources in Patients With COPD

The purpose of this study is to determine the prevalence and severity of extrapulmonary disorders and to quantify the impact of extrapulmonary organ manifestations on morbidity and mortality of COPD patients.

Furthermore the investigators evaluate the relationship between systemic inflammation and organ involvement.

Study Overview

Status

Completed

Detailed Description

Chronic diseases and comorbidities have an increasing impact on individual life and health care use, as exemplified in chronic obstructive pulmonary disease (COPD). Currently, independent, comprehensive databases allowing for an integrated view are lacking. The study will for the first time establish a large, comprehensive longitudinal database covering a broad panel of comorbidities an markers of systemic alterations. These data will be of unique value in revealing specific phenotypes of COPD via patterns and risk profiles of comorbidities, enabling a more precise diagnosis and targeting of therapy, and an efficient allocation of resources.

Study Type

Observational

Enrollment (Actual)

2741

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

      • Berlin, Germany, 13125
        • Ev. Lungenklinik (ELK), Krankenhausbetriebs gGmbH, Pneumologische Klinik
      • Borstel, Germany, 23845
        • Forschungszentrum Borstel, Medizinische Klinik
      • Donaustauf, Germany, 93093
        • Klinik Donaustauf, Zentrum für Pneumologie
      • Essen, Germany, 45239
        • Ruhrlandklinik Essen, Westdeutsches Lungenzentrum
      • Gauting, Germany, 82131
        • EvA-Study Center, Helholtz Zentrum München
      • Gießen, Germany
        • Justus-Liebig-Universität, Medizinische Klinik II
      • Greifswald, Germany, 17475
        • Universitätsklinikum Greifswald der Ernst-Moritz-Arndt Universität, Zentrum für Innere Medizin
      • Großhansdorf, Germany, 22927
        • Krankenhaus Großhansdorf, Pneumologisches Forschungsinstitut
      • Hamburg, Germany, 20354
        • HIT-Hamburger Institut für Therapieforschung GmbH
      • Hannover, Germany, 30625
        • Medical School Hannover, Dep. of Pneumology
      • Heidelberg, Germany, 69126
        • Thoraxklinik Heidelberg
      • Homburg, Germany, 66421
        • University of Saarland
      • Immenhausen, Germany, 34376
        • Fachklinik für Lungenerkrankungen Philippsstiftung ev.
      • Kiel, Germany, 24105
        • Universitiy of Kiel
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig, Department Innere Medizin
      • Marburg, Germany, 35042
        • Philipps-University Marburg, Medical Center, Dep. of Pneumology
      • Munic, Germany, 80336
        • Ludwig-Maximilians-University, Medizinische Klinik Innenstadt
      • Nürnberg, Germany, 90419
        • Klinikum Nürnberg, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie und Schlafmedizin
      • Rostock, Germany, 18057
        • Universitätsklinikum Rostock, Zentrum für Innere Medizin, Abt. f. Pneumologie
      • Schönau am Königssee, Germany, 83471
        • Klinikum Berchtesgardener Land, Schön Kliniken, Fachzentrum für Pneumologie, Allergologie und Schlafmedizin
      • Solingen, Germany, 42699
        • Krankenhaus Bethanien gGmbH
      • Würzburg, Germany, 97067
        • Missionsärztliche Klinik GmbH, Innere Medizin

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

Sampling Method

Non-Probability Sample

Study Population

Since the original recruitment strategy was not as successful as expected,the mode of recruitment was extended to other physicians, patients' groups and organisations and advertising to local media. The recruitment is supported by professional measures of communication organized by the coordinating centre Marburg.

Description

Inclusion Criteria:

  • aged 40 years and older
  • diagnosis of COPD (GOLD-Criteria) or chronic bronchitis
  • informed consent
  • available for repeated study visits pver 18 months

Exclusion Criteria:

  • having undergone big lung surgery (e.g. lung reduction, lung transplant)
  • Moderate or severe exacerbation within the last 4 weeks
  • having a lung tumor
  • Unable to walk or to understand the intention of the project

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in BODE-Score at 18 months
Time Frame: at initial visite, after 18, 36, 54, 72, 90 and 108 months
The BODE-Score comprises BMI, airway obstruction, dyspnea and exercise capacity and is a good predictor for death in COPD patients. Progression is defined as a change in BODE-score by >=1 point over the observation period.
at initial visite, after 18, 36, 54, 72, 90 and 108 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COPD related mortality
Time Frame: after 18 months
The rate of mortality was elevated after 6, 18, 36, 54, 72, 90 and 108 months
after 18 months
COPD related hospitalization
Time Frame: after 18, 36, 54, 72, 90 and 108 months
The rate of hospitalizations was elevated in every visit.
after 18, 36, 54, 72, 90 and 108 months

Collaborators and Investigators

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

Investigators

  • Study Chair: Claus Vogelmeier, Prof., Philipps University Marburg Medical Center

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.

General Publications

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

November 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

November 18, 2010

First Submitted That Met QC Criteria

November 22, 2010

First Posted (Estimated)

November 23, 2010

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Study Data/Documents

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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