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, Rainer Gloeckl, Daniela Leitl, Tessa Schneeberger, Inga Jarosch, Wolfgang Hitzl, Peter Alter, Bernd Sczepanski, Sandra Winterkamp, Martina Boensch, Carmen Schade-Brittinger, Chrysanthi Skevaki, Olaf Holz, Paul W Jones, Claus F Vogelmeier, Andreas R Koczulla, Klaus Kenn, Rainer Gloeckl, Daniela Leitl, Tessa Schneeberger, Inga Jarosch, Wolfgang Hitzl, Peter Alter, Bernd Sczepanski, Sandra Winterkamp, Martina Boensch, Carmen Schade-Brittinger, Chrysanthi Skevaki, Olaf Holz, Paul W Jones, Claus F Vogelmeier, Andreas R Koczulla

Abstract

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.

Keywords: chronic airways disease; emphysema; rehabilitation medicine; thoracic medicine.

Conflict of interest statement

Competing interests: For CS: consultancy and research funding, Hycor Biomedical, Bencard Allergie and Thermo Fisher Scientific; research funding, Mead Johnson Nutrition (MJN).

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study flow chart. AECOPD, acute exacerbation of chronic obstructive pulmonary disease; AEs, adverse events; PR, pulmonary rehabilitation; VOC, volatile organic compound.

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