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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01245933
Recruitment Status : Active, not recruiting
First Posted : November 23, 2010
Last Update Posted : April 11, 2018
Hannover Medical School
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
Claus Vogelmeier, Philipps University Marburg Medical Center

Brief Summary:

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.

Condition or disease
Chronic Obstructive Pulmonary Disease (COPD)

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
Actual Enrollment : 2741 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis and Utilisation of Health Care Resources in Patients With COPD
Study Start Date : November 2010
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : July 2021

Primary Outcome Measures :
  1. Change from baseline in BODE-Score at 18 months [ Time Frame: at initial visite, after 18 month ]
    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.

Secondary Outcome Measures :
  1. COPD related mortality [ Time Frame: after 18 months ]
  2. COPD related hospitalization [ Time Frame: after 18 months ]

Biospecimen Retention:   Samples With DNA
blood urine sputum

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01245933

Ev. Lungenklinik (ELK), Krankenhausbetriebs gGmbH, Pneumologische Klinik
Berlin, Germany, 13125
Forschungszentrum Borstel, Medizinische Klinik
Borstel, Germany, 23845
Klinik Donaustauf, Zentrum für Pneumologie
Donaustauf, Germany, 93093
Ruhrlandklinik Essen, Westdeutsches Lungenzentrum
Essen, Germany, 45239
EvA-Study Center, Helholtz Zentrum München
Gauting, Germany, 82131
Justus-Liebig-Universität, Medizinische Klinik II
Gießen, Germany
Universitätsklinikum Greifswald der Ernst-Moritz-Arndt Universität, Zentrum für Innere Medizin
Greifswald, Germany, 17475
Krankenhaus Großhansdorf, Pneumologisches Forschungsinstitut
Großhansdorf, Germany, 22927
HIT-Hamburger Institut für Therapieforschung GmbH
Hamburg, Germany, 20354
Medical School Hannover, Dep. of Pneumology
Hannover, Germany, 30625
Thoraxklinik Heidelberg
Heidelberg, Germany, 69126
University of Saarland
Homburg, Germany, 66421
Fachklinik für Lungenerkrankungen Philippsstiftung ev.
Immenhausen, Germany, 34376
Universitiy of Kiel
Kiel, Germany, 24105
Universitätsklinikum Leipzig, Department Innere Medizin
Leipzig, Germany, 04103
Philipps-University Marburg, Medical Center, Dep. of Pneumology
Marburg, Germany, 35042
Ludwig-Maximilians-University, Medizinische Klinik Innenstadt
Munic, Germany, 80336
Klinikum Nürnberg, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie und Schlafmedizin
Nürnberg, Germany, 90419
Universitätsklinikum Rostock, Zentrum für Innere Medizin, Abt. f. Pneumologie
Rostock, Germany, 18057
Klinikum Berchtesgardener Land, Schön Kliniken, Fachzentrum für Pneumologie, Allergologie und Schlafmedizin
Schönau am Königssee, Germany, 83471
Krankenhaus Bethanien gGmbH
Solingen, Germany, 42699
University of Ulm
Ulm, Germany, 89081
Missionsärztliche Klinik GmbH, Innere Medizin
Würzburg, Germany, 97067
Sponsors and Collaborators
Philipps University Marburg Medical Center
Hannover Medical School
Ludwig-Maximilians - University of Munich
Study Chair: Claus Vogelmeier, Prof. Philipps University Marburg Medical Center

Additional Information:
Study Data/Documents: general information  This link exits the site

Publications of Results:

Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Claus Vogelmeier, Prof. Dr., Philipps University Marburg Medical Center Identifier: NCT01245933     History of Changes
Other Study ID Numbers: 01GI0881
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Keywords provided by Claus Vogelmeier, Philipps University Marburg Medical Center:
systemic inflammation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases