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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— COSYCONET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245933
• Other study ID #: 01GI0881
• Status: Completed
• Start date: November 2010
• Est. completion date: December 2023

Study information

• Verified date: April 2024
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2741
• Est. completion date: December 2023
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Germany	Ev. Lungenklinik (ELK), Krankenhausbetriebs gGmbH, Pneumologische Klinik	Berlin
Germany	Forschungszentrum Borstel, Medizinische Klinik	Borstel
Germany	Klinik Donaustauf, Zentrum für Pneumologie	Donaustauf
Germany	Ruhrlandklinik Essen, Westdeutsches Lungenzentrum	Essen
Germany	EvA-Study Center, Helholtz Zentrum München	Gauting
Germany	Justus-Liebig-Universität, Medizinische Klinik II	Gießen
Germany	Universitätsklinikum Greifswald der Ernst-Moritz-Arndt Universität, Zentrum für Innere Medizin	Greifswald
Germany	Krankenhaus Großhansdorf, Pneumologisches Forschungsinstitut	Großhansdorf
Germany	HIT-Hamburger Institut für Therapieforschung GmbH	Hamburg
Germany	Medical School Hannover, Dep. of Pneumology	Hannover
Germany	Thoraxklinik Heidelberg	Heidelberg
Germany	University of Saarland	Homburg
Germany	Fachklinik für Lungenerkrankungen Philippsstiftung ev.	Immenhausen
Germany	Universitiy of Kiel	Kiel
Germany	Universitätsklinikum Leipzig, Department Innere Medizin	Leipzig
Germany	Philipps-University Marburg, Medical Center, Dep. of Pneumology	Marburg
Germany	Ludwig-Maximilians-University, Medizinische Klinik Innenstadt	Munic
Germany	Klinikum Nürnberg, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie und Schlafmedizin	Nürnberg
Germany	Universitätsklinikum Rostock, Zentrum für Innere Medizin, Abt. f. Pneumologie	Rostock
Germany	Klinikum Berchtesgardener Land, Schön Kliniken, Fachzentrum für Pneumologie, Allergologie und Schlafmedizin	Schönau am Königssee
Germany	Krankenhaus Bethanien gGmbH	Solingen
Germany	Missionsärztliche Klinik GmbH, Innere Medizin	Würzburg

Sponsors (3)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	Hannover Medical School, Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (45)

Alter P, Jorres RA, Watz H, Welte T, Glaser S, Schulz H, Bals R, Karch A, Wouters EFM, Vestbo J, Young D, Vogelmeier CF. Left ventricular volume and wall stress are linked to lung function impairment in COPD. Int J Cardiol. 2018 Jun 15;261:172-178. doi: 1 — View Citation

Alter P, Jorres RA. Concomitance of cardiovascular and pulmonary disorders: mutual bystanders or causal interactions? Kardiol Pol. 2018;76(7):1027-1028. doi: 10.5603/KP.2018.0132. No abstract available. — View Citation

Alter P, Mayerhofer BA, Kahnert K, Watz H, Waschki B, Andreas S, Biertz F, Bals R, Vogelmeier CF, Jorres RA. Prevalence of cardiac comorbidities, and their underdetection and contribution to exertional symptoms in COPD: results from the COSYCONET cohort. — View Citation

Alter P, Rabe KF, Schulz H, Vogelmeier CF, Jorres RA. Influence of body mass on predicted values of static hyperinflation in COPD. Int J Chron Obstruct Pulmon Dis. 2018 Aug 23;13:2551-2555. doi: 10.2147/COPD.S164096. eCollection 2018. — View Citation

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 — View Citation

Alter P, Watz H, Kahnert K, Rabe KF, Biertz F, Fischer R, Jung P, Graf J, Bals R, Vogelmeier CF, Jorres RA. Effects of airway obstruction and hyperinflation on electrocardiographic axes in COPD. Respir Res. 2019 Mar 27;20(1):61. doi: 10.1186/s12931-019-10 — View Citation

Byng D, Lutter JI, Wacker ME, Jorres RA, Liu X, Karrasch S, Schulz H, Vogelmeier C, Holle R. Determinants of healthcare utilization and costs in COPD patients: first longitudinal results from the German COPD cohort COSYCONET. Int J Chron Obstruct Pulmon D — View Citation

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. — View Citation

Graf J, Jorres RA, Lucke T, Nowak D, Vogelmeier CF, Ficker JH. Medical Treatment of COPD. Dtsch Arztebl Int. 2018 Sep 14;155(37):599-605. doi: 10.3238/arztebl.2018.0599. — View Citation

Graf J, Lucke T, Herrera R, Watz H, Holle R, Vogelmeier C, Ficker JH, Jorres RA. Compatibility of medication with PRISCUS criteria and identification of drug interactions in a large cohort of patients with COPD. Pulm Pharmacol Ther. 2018 Apr;49:123-129. d — View Citation

Greulich T, Mager S, Lucke T, Koczulla AR, Bals R, Fahndrich S, Jorres RA, Alter P, Kirsten A, Vogelmeier CF, Watz H. Longitudinal stability of blood eosinophil count strata in the COPD COSYCONET cohort. Int J Chron Obstruct Pulmon Dis. 2018 Sep 28;13:299 — View Citation

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 Chron — View Citation

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. — View Citation

Kahnert K, Alter P, Welte T, Huber RM, Behr J, Biertz F, Watz H, Bals R, Vogelmeier CF, Jorres RA. Uric acid, lung function, physical capacity and exacerbation frequency in patients with COPD: a multi-dimensional approach. Respir Res. 2018 Jun 4;19(1):110 — View Citation

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. Resp — View Citation

Kahnert K, Fohrenbach M, Lucke T, Alter P, Trudzinski FT, Bals R, Lutter JI, Timmermann H, Sohler S, Forderreuther S, Nowak D, Watz H, Waschki B, Behr J, Welte T, Vogelmeier CF, Jorres RA. The impact of COPD on polyneuropathy: results from the German COPD — View Citation

Kahnert K, Jobst B, Biertz F, Biederer J, Watz H, Huber RM, Behr J, Grenier PA, Alter P, Vogelmeier CF, Kauczor HU, Jorres RA. Relationship of spirometric, body plethysmographic, and diffusing capacity parameters to emphysema scores derived from CT scans. — View Citation

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 an — View Citation

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 a — View Citation

Kaireit TF, Voskrebenzev A, Gutberlet M, Freise J, Jobst B, Kauczor HU, Welte T, Wacker F, Vogel-Claussen J. Comparison of quantitative regional perfusion-weighted phase resolved functional lung (PREFUL) MRI with dynamic gadolinium-enhanced regional pulmo — View Citation

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 coho — View Citation

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 — View Citation

Keller A, Fehlmann T, Ludwig N, Kahraman M, Laufer T, Backes C, Vogelmeier C, Diener C, Biertz F, Herr C, Jorres RA, Lenhof HP, Meese E, Bals R; COSYCONET Study Group. Genome-wide MicroRNA Expression Profiles in COPD: Early Predictors for Cancer Developme — View Citation

Keller A, Ludwig N, Fehlmann T, Kahraman M, Backes C, Kern F, Vogelmeier CF, Diener C, Fischer U, Biertz F, Herr C, Jorres RA, Lenhof HP, Bals R, Meese E. Low miR-150-5p and miR-320b Expression Predicts Reduced Survival of COPD Patients. Cells. 2019 Sep 2 — View Citation

Kellerer C, Jorres RA, Schneider A, Alter P, Kauczor HU, Jobst B, Biederer J, Bals R, Watz H, Behr J, Kauffmann-Guerrero D, Lutter J, Hapfelmeier A, Magnussen H, Trudzinski FC, Welte T, Vogelmeier CF, Kahnert K. Prediction of lung emphysema in COPD by spi — View Citation

Konigsdorfer N, Jorres RA, Sohler S, Welte T, Behr J, Ficker JH, Bals R, Watz H, Lutter JI, Lucke T, Biertz F, Alter P, Vogelmeier CF, Kahnert K. Adherence To Respiratory And Nonrespiratory Medication In Patients With COPD: Results Of The German COSYCONET — View Citation

Lommatzsch M, Speer T, Herr C, Jorres RA, Watz H, Muller A, Welte T, Vogelmeier CF, Bals R; COSYCONET study group. IgE is associated with exacerbations and lung function decline in COPD. Respir Res. 2022 Jan 4;23(1):1. doi: 10.1186/s12931-021-01847-0. — View Citation

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 Ev — View Citation

Lutter JI, Jorres RA, Kahnert K, Schwarzkopf L, Studnicka M, Karrasch S, Schulz H, Vogelmeier CF, Holle R; COSYCONET Study Group. Health-related quality of life associates with change in FEV1 in COPD: results from the COSYCONET cohort. BMC Pulm Med. 2020 — View Citation

Lutter JI, Lukas M, Schwarzkopf L, Jorres RA, Studnicka M, Kahnert K, Karrasch S, Bewig B, Vogelmeier CF, Holle R; COSYCONET Study Group. Utilization and determinants of use of non-pharmacological interventions in COPD: Results of the COSYCONET cohort. Re — View Citation

Marietta von Siemens S, Alter P, Lutter JI, Kauczor HU, Jobst B, Bals R, Trudzinski FC, Sohler S, Behr J, Watz H, Waschki B, Bewig B, Jones PW, Welte T, Vogelmeier CF, Jorres RA, Kahnert K; COSYCONET study group; Names of participating study nurses. CAT s — View Citation

Omlor AJ, Trudzinski FC, Alqudrah M, Seiler F, Biertz F, Vogelmeier CF, Welte T, Watz H, Waschki B, Brinker TJ, Andreas S, Fahndrich S, Alter P, Jorres RA, Bohm M, Bals R; German COSYCONET Cohort. Time-updated resting heart rate predicts mortality in pati — View Citation

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-V — View Citation

Triphan SMF, Biederer J, Burmester K, Fellhauer I, Vogelmeier CF, Jorres RA, Kauczor HU, Heussel CP, Wielputz MO, Jobst BJ. Design and application of an MR reference phantom for multicentre lung imaging trials. PLoS One. 2018 Jul 5;13(7):e0199148. doi: 10 — View Citation

Trudzinski FC, Alqudrah M, Omlor A, Zewinger S, Fliser D, Speer T, Seiler F, Biertz F, Koch A, Vogelmeier C, Welte T, Watz H, Waschki B, Fahndrich S, Jorres R, Bals R; German COSYCONET consortium. Consequences of chronic kidney disease in chronic obstruct — View Citation

Trudzinski FC, Jorres RA, Alter P, Kahnert K, Waschki B, Herr C, Kellerer C, Omlor A, Vogelmeier CF, Fahndrich S, Watz H, Welte T, Jany B, Sohler S, Biertz F, Herth F, Kauczor HU, Bals R; COSYCONET consortium. Associations of oxygenated hemoglobin with di — View Citation

Trudzinski FC, Jorres RA, Alter P, Walter J, Watz H, Koch A, John M, Lommatzsch M, Vogelmeier CF, Kauczor HU, Welte T, Behr J, Tufman A, Bals R, Herth FJF, Kahnert K; COSYCONET Study Group. Sex-specific associations of comorbidome and pulmorbidome with mo — View Citation

Trudzinski FC, Kahnert K, Vogelmeier CF, Alter P, Seiler F, Fahndrich S, Watz H, Welte T, Speer T, Zewinger S, Biertz F, Kauczor HU, Jorres RA, Bals R; COSYCONET consortium. Combined effects of lung function, blood gases and kidney function on the exacerb — View Citation

von Siemens SM, Jorres RA, Behr J, Alter P, Lutter J, Lucke T, Sohler S, Welte T, Watz H, Vogelmeier CF, Trudzinski F, Rief W, Herbig B, Kahnert K; COSYCONET study group. Effect of COPD severity and comorbidities on the result of the PHQ-9 tool for the di — View Citation

von Siemens SM, Perneczky R, Vogelmeier CF, Behr J, Kauffmann-Guerrero D, Alter P, Trudzinski FC, Bals R, Grohe C, Sohler S, Waschki B, Lutter JI, Welte T, Jorres RA, Kahnert K; COSYCONET study group. The association of cognitive functioning as measured b — View Citation

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 — View Citation

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 — View Citation

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 — View Citation

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 — View Citation

Waschki B, Alter P, Zeller T, Magnussen C, Neumann JT, Twerenbold R, Sinning C, Herr C, Kahnert K, Fahndrich S, Blankenberg S, Rabe KF, Welte T, Jorres RA, Vogelmeier CF, Bals R, Watz H; German COSYCONET Cohort. High-sensitivity troponin I and all-cause m — View Citation

* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at initial visite, after 18, 36, 54, 72, 90 and 108 months
Secondary	COPD related mortality	The rate of mortality was elevated after 6, 18, 36, 54, 72, 90 and 108 months	after 18 months
Secondary	COPD related hospitalization	The rate of hospitalizations was elevated in every visit.	after 18, 36, 54, 72, 90 and 108 months

External Links

•   Description of the study, study results, links to relevant organisaton