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Chronic Obstructive Pulmonary Disease (COPD)COSYCONETNCT01245933

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

An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Philipps University Marburg at 22 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
How many people
2,741 participants
Where
22 sitesGermany
Study dates
Nov 2010to Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Germany22 sites

  • Ev. Lungenklinik (ELK), Krankenhausbetriebs gGmbH, Pneumologische Klinik

    Berlin, 13125

  • Forschungszentrum Borstel, Medizinische Klinik

    Borstel, 23845

  • Klinik Donaustauf, Zentrum für Pneumologie

    Donaustauf, 93093

  • Ruhrlandklinik Essen, Westdeutsches Lungenzentrum

    Essen, 45239

  • EvA-Study Center, Helholtz Zentrum München

    Gauting, 82131

  • Justus-Liebig-Universität, Medizinische Klinik II

    Giessen

  • Universitätsklinikum Greifswald der Ernst-Moritz-Arndt Universität, Zentrum für Innere Medizin

    Greifswald, 17475

  • Krankenhaus Großhansdorf, Pneumologisches Forschungsinstitut

    Großhansdorf, 22927

  • HIT-Hamburger Institut für Therapieforschung GmbH

    Hamburg, 20354

  • Medical School Hannover, Dep. of Pneumology

    Hanover, 30625

  • Thoraxklinik Heidelberg

    Heidelberg, 69126

  • University of Saarland

    Homburg, 66421

  • Fachklinik für Lungenerkrankungen Philippsstiftung ev.

    Immenhausen, 34376

  • Universitiy of Kiel

    Kiel, 24105

  • Universitätsklinikum Leipzig, Department Innere Medizin

    Leipzig, 04103

  • Philipps-University Marburg, Medical Center, Dep. of Pneumology

    Marburg, 35042

  • Ludwig-Maximilians-University, Medizinische Klinik Innenstadt

    Munich, 80336

  • Klinikum Nürnberg, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie und Schlafmedizin

    Nuremberg, 90419

  • Universitätsklinikum Rostock, Zentrum für Innere Medizin, Abt. f. Pneumologie

    Rostock, 18057

  • Klinikum Berchtesgardener Land, Schön Kliniken, Fachzentrum für Pneumologie, Allergologie und Schlafmedizin

    Schönau am Königssee, 83471

  • Krankenhaus Bethanien gGmbH

    Solingen, 42699

  • Missionsärztliche Klinik GmbH, Innere Medizin

    Würzburg, 97067

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Keywords
COPD, register, comorbidities, systemic inflammation
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in BODE-Score at 18 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.

    Measured: at initial visite, after 18, 36, 54, 72, 90 and 108 months

Secondary outcomes (2)

  1. COPD related mortality

    The rate of mortality was elevated after 6, 18, 36, 54, 72, 90 and 108 months

    Measured: after 18 months

  2. COPD related hospitalization

    The rate of hospitalizations was elevated in every visit.

    Measured: after 18, 36, 54, 72, 90 and 108 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionDec 2013
  4. Study completionDec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,741 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01245933
Sponsor's protocol ID
01GI0881
Acronym
COSYCONET
Status last verified
Apr 2024
First submitted
18 Nov 2010
Last updated
12 Apr 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Jorres RA, Welte T, Bals R, Koch A, Schnoor M, Vogelmeier C. [Systemic manifestations and comorbidities in patients with chronic obstructive pulmonary disease (COPD) and their effect on clinical state and course of the disease--an overview of the cohort study COSYCONET]. Dtsch Med Wochenschr. 2010 Mar;135(10):446-9. doi: 10.1055/s-0030-1249185. Epub 2010 Mar 2. German.

    PubMed 20198540

  • Wacker ME, Jorres RA, Schulz H, Heinrich J, Karrasch S, Karch A, Koch A, Peters A, Leidl R, Vogelmeier C, Holle R; COSYCONET-Consortium. Direct and indirect costs of COPD and its comorbidities: Results from the German COSYCONET study. Respir Med. 2016 Feb;111:39-46. doi: 10.1016/j.rmed.2015.12.001. Epub 2015 Dec 10.

    PubMed 26725462

  • Karch A, Vogelmeier C, Welte T, Bals R, Kauczor HU, Biederer J, Heinrich J, Schulz H, Glaser S, Holle R, Watz H, Korn S, Adaskina N, Biertz F, Vogel C, Vestbo J, Wouters EF, Rabe KF, Sohler S, Koch A, Jorres RA; COSYCONET Study Group. The German COPD cohort COSYCONET: Aims, methods and descriptive analysis of the study population at baseline. Respir Med. 2016 May;114:27-37. doi: 10.1016/j.rmed.2016.03.008. Epub 2016 Mar 11.

    PubMed 27109808

  • Wacker ME, Jorres RA, Karch A, Wilke S, Heinrich J, Karrasch S, Koch A, Schulz H, Watz H, Leidl R, Vogelmeier C, Holle R; COSYCONET-Consortium. Assessing health-related quality of life in COPD: comparing generic and disease-specific instruments with focus on comorbidities. BMC Pulm Med. 2016 May 10;16(1):70. doi: 10.1186/s12890-016-0238-9.

    PubMed 27160582

  • Wacker ME, Jorres RA, Karch A, Koch A, Heinrich J, Karrasch S, Schulz H, Peters A, Glaser S, Ewert R, Baumeister SE, Vogelmeier C, Leidl R, Holle R; COSYCONET study group. Relative impact of COPD and comorbidities on generic health-related quality of life: a pooled analysis of the COSYCONET patient cohort and control subjects from the KORA and SHIP studies. Respir Res. 2016 Jul 12;17(1):81. doi: 10.1186/s12931-016-0401-0.

    PubMed 27405652

  • Lucke T, Herrera R, Wacker M, Holle R, Biertz F, Nowak D, Huber RM, Sohler S, Vogelmeier C, Ficker JH, Muckter H, Jorres RA; COSYCONET-Consortium. Systematic Analysis of Self-Reported Comorbidities in Large Cohort Studies - A Novel Stepwise Approach by Evaluation of Medication. PLoS One. 2016 Oct 28;11(10):e0163408. doi: 10.1371/journal.pone.0163408. eCollection 2016.

    PubMed 27792735

  • Alter P, Watz H, Kahnert K, Pfeifer M, Randerath WJ, Andreas S, Waschki B, Kleibrink BE, Welte T, Bals R, Schulz H, Biertz F, Young D, Vogelmeier CF, Jorres RA. Airway obstruction and lung hyperinflation in COPD are linked to an impaired left ventricular diastolic filling. Respir Med. 2018 Apr;137:14-22. doi: 10.1016/j.rmed.2018.02.011. Epub 2018 Feb 19.

    PubMed 29605197

  • Kahnert K, Lucke T, Huber RM, Behr J, Biertz F, Vogt A, Watz H, Alter P, Fahndrich S, Bals R, Holle R, Karrasch S, Sohler S, Wacker M, Ficker JH, Parhofer KG, Vogelmeier C, Jorres RA; COSYCONET consortium. Relationship of hyperlipidemia to comorbidities and lung function in COPD: Results of the COSYCONET cohort. PLoS One. 2017 May 15;12(5):e0177501. doi: 10.1371/journal.pone.0177501. eCollection 2017.

    PubMed 28505167

  • Fahndrich S, Biertz F, Karch A, Kleibrink B, Koch A, Teschler H, Welte T, Kauczor HU, Janciauskiene S, Jorres RA, Greulich T, Vogelmeier CF, Bals R; COSYCONET investigators. Cardiovascular risk in patients with alpha-1-antitrypsin deficiency. Respir Res. 2017 Sep 15;18(1):171. doi: 10.1186/s12931-017-0655-1.

    PubMed 28915894

  • Kahnert K, Alter P, Young D, Lucke T, Heinrich J, Huber RM, Behr J, Wacker M, Biertz F, Watz H, Bals R, Welte T, Wirtz H, Herth F, Vestbo J, Wouters EF, Vogelmeier CF, Jorres RA. The revised GOLD 2017 COPD categorization in relation to comorbidities. Respir Med. 2018 Jan;134:79-85. doi: 10.1016/j.rmed.2017.12.003. Epub 2017 Dec 5.

    PubMed 29413512

  • Kahnert K, Lucke T, Biertz F, Lechner A, Watz H, Alter P, Bals R, Behr J, Holle R, Huber RM, Karrasch S, Stubbe B, Wacker M, Sohler S, Wouters EF, Vogelmeier C, Jorres RA; COSYCONET study group. Transfer factor for carbon monoxide in patients with COPD and diabetes: results from the German COSYCONET cohort. Respir Res. 2017 Jan 13;18(1):14. doi: 10.1186/s12931-016-0499-0.

    PubMed 28086884

  • Houben-Wilke S, Jorres RA, Bals R, Franssen FM, Glaser S, Holle R, Karch A, Koch A, Magnussen H, Obst A, Schulz H, Spruit MA, Wacker ME, Welte T, Wouters EF, Vogelmeier C, Watz H. Peripheral Artery Disease and Its Clinical Relevance in Patients with Chronic Obstructive Pulmonary Disease in the COPD and Systemic Consequences-Comorbidities Network Study. Am J Respir Crit Care Med. 2017 Jan 15;195(2):189-197. doi: 10.1164/rccm.201602-0354OC.

    PubMed 27532739

  • Karl FM, Holle R, Bals R, Greulich T, Jorres RA, Karch A, Koch A, Karrasch S, Leidl R, Schulz H, Vogelmeier C, Wacker ME; COSYCONET Study Group. Costs and health-related quality of life in Alpha-1-Antitrypsin Deficient COPD patients. Respir Res. 2017 Apr 17;18(1):60. doi: 10.1186/s12931-017-0543-8.

    PubMed 28416015

  • Smid DE, Franssen FME, Gonik M, Miravitlles M, Casanova C, Cosio BG, de Lucas-Ramos P, Marin JM, Martinez C, Mir I, Soriano JB, de Torres JP, Agusti A, Atalay NB, Billington J, Boutou AK, Brighenti-Zogg S, Chaplin E, Coster S, Dodd JW, Durr S, Fernandez-Villar A, Groenen MTJ, Guimaraes M, Hejduk K, Higgins V, Hopkinson NS, Horita N, Houben-Wilke S, Janssen DJA, Jehn M, Joerres R, Karch A, Kelly JL, Kim YI, Kimura H, Koblizek V, Kocks JH, Kon SSC, Kwon N, Ladeira I, Lee SD, Leuppi JD, Locantore N, Lopez-Campos JL, D-C Man W, Maricic L, Mendoza L, Miedinger D, Mihaltan F, Minami S, van der Molen T, Murrells TJ, Nakken N, Nishijima Y, Norman IJ, Novotna B, O'Donnell DE, Ogata Y, Pereira ED, Piercy J, Price D, Pothirat C, Raghavan N, Ringbaek T, Sajkov D, Sigari N, Singh S, Small M, da Silva GF, Tanner RJ, Tsiligianni IG, Tulek B, Tzanakis N, Vanfleteren LEGW, Watz H, Webb KA, Wouters EFM, Xie GG, Yoshikawa M, Spruit MA. Redefining Cut-Points for High Symptom Burden of the Global Initiative for Chronic Obstructive Lung Disease Classification in 18,577 Patients With Chronic Obstructive Pulmonary Disease. J Am Med Dir Assoc. 2017 Dec 1;18(12):1097.e11-1097.e24. doi: 10.1016/j.jamda.2017.09.003.

    PubMed 29169740

  • Wacker ME, Kitzing K, Jorres RA, Leidl R, Schulz H, Karrasch S, Karch A, Koch A, Vogelmeier CF, Holle R. The contribution of symptoms and comorbidities to the economic impact of COPD: an analysis of the German COSYCONET cohort. Int J Chron Obstruct Pulmon Dis. 2017 Dec 4;12:3437-3448. doi: 10.2147/COPD.S141852. eCollection 2017.

    PubMed 29270005

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Philipps University Marburg at 22 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in BODE-Score at 18 months (time frame: at initial visite, after 18, 36, 54, 72, 90 and 108 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01245933, which also lists 62 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.

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