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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01245933

Acronym

COSYCONET

Enrollment

2741

Registered

2010-11-23

Start date

2010-11-30

Completion date

2023-12-31

Last updated

2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, register, comorbidities, systemic inflammation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Germany

Outcome results