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OpenTrials
Completed

NCT Number: NCT01245933

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. COPD related mortality

    Time frame: after 18 months

    The rate of mortality was elevated after 6, 18, 36, 54, 72, 90 and 108 months

  2. COPD related hospitalization

    Time frame: after 18, 36, 54, 72, 90 and 108 months

    The rate of hospitalizations was elevated in every visit.

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Collaborators

  • Hannover Medical School
  • Ludwig-Maximilians - University of Munich

Registry information

Official study title

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

Acronym: COSYCONET

Important dates

Study start
2010
Primary completion
2013
Study completion
2023
First posted
Nov 23, 2010
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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