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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT01245933
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-18
• Study First Submitted QC: 2010-11-22
• Study First Posted: 2010-11-23
• Primary Completion: 2013-12
• Study Completion: 2023-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2741

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (22)

HIT-Hamburger Institut für Therapieforschung GmbH; 🇩🇪 Hamburg, Germany

Krankenhaus Großhansdorf, Pneumologisches Forschungsinstitut; 🇩🇪 Großhansdorf, 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

Universitätsklinikum Rostock, Zentrum für Innere Medizin, Abt. f. Pneumologie; 🇩🇪 Rostock, Germany

Missionsärztliche Klinik GmbH, Innere Medizin; 🇩🇪 Würzburg, Germany

Klinik Donaustauf, Zentrum für Pneumologie; 🇩🇪 Donaustauf, Germany

Ev. Lungenklinik (ELK), Krankenhausbetriebs gGmbH, Pneumologische Klinik; 🇩🇪 Berlin, Germany

Forschungszentrum Borstel, Medizinische Klinik; 🇩🇪 Borstel, Germany

Ruhrlandklinik Essen, Westdeutsches Lungenzentrum; 🇩🇪 Essen, Germany

Universitätsklinikum Greifswald der Ernst-Moritz-Arndt Universität, Zentrum für Innere Medizin; 🇩🇪 Greifswald, Germany

Thoraxklinik Heidelberg; 🇩🇪 Heidelberg, Germany

Krankenhaus Bethanien gGmbH; 🇩🇪 Solingen, Germany

EvA-Study Center, Helholtz Zentrum München; 🇩🇪 Gauting, Germany

University of Saarland; 🇩🇪 Homburg, Germany

Klinikum Berchtesgardener Land, Schön Kliniken, Fachzentrum für Pneumologie, Allergologie und Schlafmedizin; 🇩🇪 Schönau am Königssee, Germany

Justus-Liebig-Universität, Medizinische Klinik II; 🇩🇪 Gießen, Germany

Medical School Hannover, Dep. of Pneumology; 🇩🇪 Hannover, Germany

Fachklinik für Lungenerkrankungen Philippsstiftung ev.; 🇩🇪 Immenhausen, Germany

Universitiy of Kiel; 🇩🇪 Kiel, Germany

Klinikum Nürnberg, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie und Schlafmedizin; 🇩🇪 Nürnberg, Germany