Protocol for an observational study to identify potential predictors of an acute exacerbation in patients with chronic obstructive pulmonary disease (the PACE Study)
Klaus Kenn,
Paul W Jones,
Carmen Schade-Brittinger,
Rainer Gloeckl,
Daniela Leitl,
Tessa Schneeberger,
Inga Jarosch,
Wolfgang Hitzl,
Peter Alter,
Bernd Sczepanski,
Sandra Winterkamp,
Martina Boensch,
Chrysanthi Skevaki,
Olaf Holz,
Claus F Vogelmeier,
Andreas R Koczulla
Affiliations
Klaus Kenn
Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, Germany
Paul W Jones
Division of Clinical Sciences, St George`s, University of London, London, UK
Carmen Schade-Brittinger
5 Department for the Coordination of Clinical Studies, University of Marburg, Marburg, Germany
Rainer Gloeckl
Department of Pulmonary Rehabilitation, Philipps-University of Marburg, Marburg, Germany
Daniela Leitl
Department of Pulmonary Rehabilitation, Philipps-University of Marburg, Marburg, Germany
Tessa Schneeberger
Department of Pulmonary Rehabilitation, Philipps-University of Marburg, Marburg, Germany
Inga Jarosch
Department of Pulmonary Rehabilitation, Philipps-University of Marburg, Marburg, Germany
Wolfgang Hitzl
Research and Innovation Management, Biostatistics, Paracelsus Medical University, Salzburg, Austria
Peter Alter
Department of Medicine, Pulmonary and Critical Care Medicine, Philipps University of Marburg, Marburg, Germany
Bernd Sczepanski
Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, Germany
Sandra Winterkamp
Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, Germany
Martina Boensch
Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, Germany
Chrysanthi Skevaki
Institute of Laboratory Medicine, Universities of Giessen and Marburg Lung Center (UGMLC), Member of the German Center for Lung Research (DZL), Marburg, Germany
Olaf Holz
Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Member of the German Center for Lung Research (DZL), Hannover, Germany
Claus F Vogelmeier
Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Centre Giessen and Marburg, Philipps-University Marburg, German Center for Lung Research (DZL), Marburg, Germany
Andreas R Koczulla
Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, Germany
Introduction Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are the most critical 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. Although there is no distinct definition or detailed knowledge about AECOPD, it is commonly used as primary outcome in clinical studies. Furthermore, it may be difficult in clinical practice to differentiate the worsening of symptoms due to an AECOPD or to the development of heart failure. Therefore, it is of major clinical importance to investigate the underlying pathophysiology, and if possible, predictors of an AECOPD and thus to identify patients who are at high risk for developing an acute exacerbation.Methods and analysis In total, 355 patients with COPD will be included prospectively to this study during a 3-week inpatient pulmonary rehabilitation programme at the Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee (Germany). All patients will be closely monitored from admission to discharge. Lung function, exercise tests, clinical parameters, quality of life, physical activity and symptoms will be recorded, and blood samples and exhaled air will be collected. If a patient develops an AECOPD, there will be additional comprehensive diagnostic assessments to differentiate between cardiac, pulmonary or cardiopulmonary causes of worsening. Follow-up measures will be performed at 6, 12 and 24 months.Exploratory data analyses methods will be used for the primary research question (screening and identification of possible factors to predict an AECOPD). Regression analyses and a generalised linear model with a binomial outcome (AECOPD) will be applied to test if predictors are significant.Ethics and dissemination This study has been approved by the Ethical Committee of the Philipps University Marburg, Germany (No. 61/19). The results will be presented in conferences and published in a peer-reviewed journal.Trial registration number NCT04140097.
