PT  - JOURNAL ARTICLE
AU  - Klaus Kenn
AU  - Rainer Gloeckl
AU  - Daniela Leitl
AU  - Tessa Schneeberger
AU  - Inga Jarosch
AU  - Wolfgang Hitzl
AU  - Peter Alter
AU  - Bernd Sczepanski
AU  - Sandra Winterkamp
AU  - Martina Boensch
AU  - Carmen Schade-Brittinger
AU  - Chrysanthi Skevaki
AU  - Olaf Holz
AU  - Paul W Jones
AU  - Claus F Vogelmeier
AU  - Andreas R Koczulla
TI  - Protocol for an observational study to identify potential predictors of an acute exacerbation in patients with chronic obstructive pulmonary disease (the PACE Study)
AID  - 10.1136/bmjopen-2020-043014
DP  - 2021 Feb 01
TA  - BMJ Open
PG  - e043014
VI  - 11
IP  - 2
4099  - http://bmjopen.bmj.com/content/11/2/e043014.short
4100  - http://bmjopen.bmj.com/content/11/2/e043014.full
SO  - BMJ Open2021 Feb 01; 11
AB  - 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.