Predictors of Acute Exacerbation in Patients With COPD - an Observational Study

Summary

Chronic obstructive pulmonary disease (COPD) is a lung disease characterized by respiratory problems and poor airflow with dyspnea and cough being the main symptoms. Acute exacerbations of COPD (AECOPD) are the most important events for patients with COPD that have a negative impact on patients´ quality of life, accelerate disease progression, and can result in hospital admissions and death. It is of major clinical importance to determine predictors of an AECOPD and to identify patients who are at high risk for developing an acute exacerbation and/or to detect the beginning of or prevent an ongoing acute exacerbation as early as possible. Until now, research in the field of AECOPD has gathered and analyzed data only after manifestation of AECOPD until recovery and most of them used a retrospective study design. Therefore, the aim of this prospective trial is to collect clinical data in patients prior to the first visible clinical signs of an AECOPD to investigate potential early predictors of an AECOPD.

Conditions

• Chronic Obstructive Pulmonary Disease
• COPD
• COPD Exacerbation
• COPD Exacerbation Acute

Interventions

OTHER

Prospective monitoring of a large variety of parameters

Patients will be recruited during an inpatient pulmonary rehabilitation program. This setting offers a unique opportunity to study the phenomenon of an acute exacerbation of the Chronic Obstructive Pulmonary Disease prior to the first visible clinical sign and further on to have a follow up of the underlying mechanisms. All COPD patients that are referred to the reference center for a rehabilitation program will be included after providing written informed consent. Prospectively, a wide range of measurements will be collected. If a patient develops an acute exacerbation there will be a comprehensive diagnostic assessment to differentiate between pulmonary, cardiac or cardio-pulmonary reasons for the exacerbation. The clinical diagnosis of an AECOPD will be made by a pulmonologist according to criteria of international guidelines within the first 24h of clinical symptoms suggestive of an exacerbation.

Sponsors & Collaborators

• GlaxoSmithKline GmbH & Co. KG (Munich, Germany)

  collaborator UNKNOWN

• Coordinating Center for Clinical Trials (KKS; Philipps-University of Marburg, Germany)

  collaborator UNKNOWN

• Research Office (Biostatistics), Paracelsus Medical University (Salzburg, Austria)

  collaborator UNKNOWN

• Fraunhofer ITEM, Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research (Hannover, Germany)

  collaborator UNKNOWN

• Institute of Laboratory Medicine and Pathobiochemistry, Molecular Diagnostics, Philipps University Marburg (Marburg, Germany)

  collaborator UNKNOWN

• Schön Klinik Berchtesgadener Land

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-26

Primary Completion

2024-04-30

Completion

2026-04-30

Countries

• Germany

Study Locations