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

Sponsor

Philipps University Marburg Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01245933

Collaborator

Hannover Medical School (Other), Ludwig-Maximilians - University of Munich (Other)

2,741

Enrollment

Locations

142

Duration (Months)

124.6

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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 Design

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 :

Nov 1, 2010

Actual Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Sep 1, 2022

Outcome Measures

Primary Outcome Measures

Change from baseline in BODE-Score at 18 months [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.

Secondary Outcome Measures

COPD related mortality [after 18 months]
The rate of mortality was elevated after 6, 18, 36, 54, 72, 90 and 108 months
COPD related hospitalization [after 18, 36, 54, 72, 90 and 108 months]
The rate of hospitalizations was elevated in every visit.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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