Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease (copd)
Treatment analysis of sleep disturbances
Sponsor Philipps University Marburg Medical Center
Collaborator Hannover Medical School
Start date November 2010
End date December 2013
Trial size 2741 participants
Trial identifier NCT01245933, 01GI0881

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Change from baseline in BODE-Score at 18 months
time frame: at initial visite, after 18 month

Secondary Outcomes

Measure
COPD related mortality
time frame: after 18 months
COPD related hospitalization
time frame: after 18 months

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis and Utilisation of Health Care Resources in Patients With COPD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Philipps University Marburg Medical Center.