Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis and Utilisation of Health Care Resources in Patients With COPD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Sponsor
- Philipps University Marburg Medical Center
- Enrollment
- 2741
- Locations
- 22
- Primary Endpoint
- Change from baseline in BODE-Score at 18 months
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Claus Vogelmeier
Prof. Dr.
Philipps University Marburg Medical Center
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
Outcomes
Primary Outcomes
Change from baseline in BODE-Score at 18 months
Time Frame: 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 Outcomes
- COPD related hospitalization(after 18, 36, 54, 72, 90 and 108 months)
- COPD related mortality(after 18 months)