Clinical trial NCT01245933: Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis, Utilisation of Health Care Resources in Patients With COPD
Official title: Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis and Utilisation of Health Care Resources in Patients With COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
register
comorbidities
systemic inflammation
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Hannover Medical School
name: Ludwig-Maximilians - University of Munich
First posted: 2010-11-23
Enrollment: 2741
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in BODE-Score at 18 months
timeFrame: at initial visite, after 18, 36, 54, 72, 90 and 108 months
Secondary outcomes:
measure: COPD related mortality
timeFrame: after 18 months
measure: COPD related hospitalization
timeFrame: after 18, 36, 54, 72, 90 and 108 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Ev. Lungenklinik (ELK), Krankenhausbetriebs gGmbH, Pneumologische Klinik
city: Borstel
country: Germany
facility: Forschungszentrum Borstel, Medizinische Klinik
city: Donaustauf
country: Germany
facility: Klinik Donaustauf, Zentrum für Pneumologie
city: Essen
country: Germany
facility: Ruhrlandklinik Essen, Westdeutsches Lungenzentrum
city: Gauting
country: Germany
facility: EvA-Study Center, Helholtz Zentrum München
city: Gießen
country: Germany
facility: Justus-Liebig-Universität, Medizinische Klinik II
city: Greifswald
country: Germany
facility: Universitätsklinikum Greifswald der Ernst-Moritz-Arndt Universität, Zentrum für Innere Medizin
city: Großhansdorf
country: Germany
facility: Krankenhaus Großhansdorf, Pneumologisches Forschungsinstitut
city: Hamburg
country: Germany
facility: HIT-Hamburger Institut für Therapieforschung GmbH
city: Hannover
country: Germany
facility: Medical School Hannover, Dep. of Pneumology
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
city: Homburg
country: Germany
facility: University of Saarland
city: Immenhausen
country: Germany
facility: Fachklinik für Lungenerkrankungen Philippsstiftung ev.
city: Kiel
country: Germany
facility: Universitiy of Kiel
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig, Department Innere Medizin
city: Marburg
country: Germany
facility: Philipps-University Marburg, Medical Center, Dep. of Pneumology
city: Munic
country: Germany
facility: Ludwig-Maximilians-University, Medizinische Klinik Innenstadt
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie und Schlafmedizin
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock, Zentrum für Innere Medizin, Abt. f. Pneumologie
city: Schönau am Königssee
country: Germany
facility: Klinikum Berchtesgardener Land, Schön Kliniken, Fachzentrum für Pneumologie, Allergologie und Schlafmedizin
city: Solingen
country: Germany
facility: Krankenhaus Bethanien gGmbH
city: Würzburg
country: Germany
facility: Missionsärztliche Klinik GmbH, Innere Medizin
Study officials:
affiliation: Philipps University Marburg
name: Claus Vogelmeier, Prof.
role: STUDY_CHAIR
References:
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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.
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 spirometry and clinical symptoms: results from COSYCONET. Respir Res. 2021 Sep 9;22(1):242. doi: 10.1186/s12931-021-01837-2.
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 mortality in chronic obstructive pulmonary disease: results from COSYCONET. Sci Rep. 2022 May 24;12(1):8790. doi: 10.1038/s41598-022-12828-8.
citation: Kahnert K, Jorres RA, Lucke T, Trudzinski FC, Mertsch P, Bickert C, Ficker JH, Behr J, Bals R, Watz H, Welte T, Vogelmeier CF, Alter P; COSYCONET Study Group. Lower Prevalence of Osteoporosis in Patients with COPD Taking Anti-Inflammatory Compounds for the Treatment of Diabetes: Results from COSYCONET. Int J Chron Obstruct Pulmon Dis. 2021 Nov 24;16:3189-3199. doi: 10.2147/COPD.S335029. eCollection 2021.
citation: Trudzinski FC, Kellerer C, Jorres RA, Alter P, Lutter JI, Trinkmann F, Herth FJF, Frankenberger M, Watz H, Vogelmeier CF, Kauczor HU, Welte T, Behr J, Bals R, Kahnert K. Gender-specific differences in COPD symptoms and their impact for the diagnosis of cardiac comorbidities. Clin Res Cardiol. 2023 Feb;112(2):177-186. doi: 10.1007/s00392-021-01915-x. Epub 2021 Jul 31.
citation: Kellerer C, Kahnert K, Trudzinski FC, Lutter J, Berschneider K, Speicher T, Watz H, Bals R, Welte T, Vogelmeier CF, Jorres RA, Alter P. COPD maintenance medication is linked to left atrial size: Results from the COSYCONET cohort. Respir Med. 2021 Aug-Sep;185:106461. doi: 10.1016/j.rmed.2021.106461. Epub 2021 May 29.
citation: Alter P, Orszag J, Kellerer C, Kahnert K, Speicher T, Watz H, Bals R, Welte T, Vogelmeier CF, Jorres RA. Prediction of air trapping or pulmonary hyperinflation by forced spirometry in COPD patients: results from COSYCONET. ERJ Open Res. 2020 Jul 27;6(3):00092-2020. doi: 10.1183/23120541.00092-2020. eCollection 2020 Jul.