Acute Exacerbation and Respiratory InfectionS in COPD (AERIS): protocol for a prospective, observational cohort study

Bourne, Simon; Cohet, Catherine; Kim, Viktoriya; Barton, Anna; Tuck, Andy; Aris, Emmanuel; Mesia-Vela, Sonia; Devaster, Jeanne-Marie; Ballou, W Ripley; Clarke, Stuart; Wilkinson, Tom

The AERIS study has been initiated to comprehensively assess the role of infectious pathogens in AECOPD in a well-characterised cohort of patients. The study aims atot exploreing the dynamics of airway infection and its possible contribution to AECOPD, as well as the potential role of chronic colonization in stable disease. The overall objective of the study will aim at refining the case definition of AECOPD to reflect the possible microbiological aetiology of exacerbations. This is of note, since there is currently no commonly agreed definition of AECOPD and no current case definition includes a microbiological endpoint. The impact of AECOPD on healthrelated quality-of-life and healthcare use will be assessed in order to provide a complete picture of disease burden. The interaction between airway infection and systemic manifestations of COPD and nutritional status will also be assessed in detail for the first time. Biological specimens collected during the study may also be used for further disease-related testing, including molecular typing to describe and compare 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 To our knowledge, few other studies have employed real-time electronic tracking of symptoms to identify AECOPD and potential aetiological triggers. This is important since available data suggest that up to 50% of exacerbations may not be reported to healthcare providers and consequently exacerbation rates are lower in studies employing event-based criteria to define AECOPD. 36 Due to the close daily monitoring of symptoms to identify AECOPD, we anticipate that the exacerbation rate in this study will be higher than previously reported. This close monitoring and early therapeutic intervention at exacerbation may also impact on estimates of the overall burden of disease.