Study protocol: pneumonia and inhaled corticosteroid treatment patterns in chronic obstructive pulmonary disease - a cohort study using sequence analysis (PICCS).

introductionTreatment with inhaled corticosteroids (ICS) is a widely used treatment in chronic obstructive pulmonary disease. The main effects include a reduction in the number of exacerbations and, for some patients, an increase in expected mortality. Unfortunately, the treatment is also linked to an increased risk of pneumonia, and very little is known about which patients experience this increased risk. There is a need for identification of patient characteristics associated with increased risk of pneumonia and treatment with ICS. METHODS AND ANALYSIS: This is a register-based cohort study that uses the nationwide Danish registers. Data from several registers in the years 2008-2018 will be merged on an individual level using the personal identification numbers that are unique to every citizen in Denmark. Clusters based on pneumonia incidence and ICS treatment patterns will be explored with a sequence analysis in a 3-year follow-up period. ETHICS AND DISSEMINATION: This is a register-based study and research ethics approval is not required according to Danish Law and National Ethics Committee Guidelines. The results will be submitted to peer-reviewed journals and reported at appropriate national and international meetings.