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

A major strength of the AERIS study design is the comprehensive assessment of clinical status, microbiology, functional status, nutritional status, health-related quality-of-life and healthcare resource utilisation in individual patients in a single large cohort during both stable COPD and AECOPD. The selection of subjects with a history of at least a single exacerbation enriches the cohort to some degree and ensures an adequate number of exacerbations are sampled. It is accepted that some aspects of the analysis may not be generalizable to the subgroup of patients who never exacerbate. The analyses proposed in this study will generate epidemiological data to complement that derived from existing COPD cohorts and further explore determinants of COPD and the contribution of bacterial and viral pathogens to AECOPD, as well as to provide some understanding of the limitations of existing data. As exacerbation visits are triggered by patient diary data, accurate and timely diary completion is essential. All subjects participating in this study receive diary training at enrolment and support is available from the study team at all times to promote accurate and complete diary keeping. Cohort retention is a key factor in the successful delivery of such a study and with in-depth sampling protocols, participant engagement, comfort and feedback are key factors in optimising cohort retention and comprehensive data collection. 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 Combinations of LABA and inhaled corticosteroids are also used in patients with more severe disease and/or frequent exacerbations. Long-term treatment with macrolide antibiotics and pulsed quinolone therapy may be considered for exacerbation prevention. 7, 43, 44 However, concerns exist about the potential for development of antimicrobial resistance during long-term antibiotic therapy.