A retrospective study to determine the optimal timing of triple therapy in subjects with chronic obstructive pulmonary disease

Trial description: COPD is a common, preventable and treatable condition of the lungs that is typically characterized by persistent airflow limitation, which becomes more severe over time. In individual subjects, exacerbations and comorbidities impact the overall severity of the condition. COPD is the second most prevalent lung disease in the UK. Exacerbations of COPD are an increase in the severity of symptoms such as dyspnoea, coughing and wheezing and are typically triggered by bacterial/viral infections or air pollution. The use of multiple inhaler triple therapy (MITT) has been observed in real-world clinical practice through observational studies. But, study results suggested that MITT was overused and incorrectly placed within the treatment pathway. Therefore, there is a need to address the timing of therapies within the COPD subject pathway. This study will support the optimal MITT treatment scheduling for COPD subjects in the UK by demonstrating outcomes associated with timing of MITT initiation during the disease pathway. The primary objective of this retrospective, longitudinal cohort study is to estimate all-cause and COPD-related healthcare resource utilisation (HCRU) and direct healthcare costs of subjects with COPD initiating MITT early (less than or equal to 30 days) versus delayed (31 to 180 days) following a moderate or severe exacerbation. This study will conduct a retrospective database analysis using UK national health service (NHS) data from Jul-2011 to Dec-2017 to understand whether the timing of MITT initiation post-exacerbation influences future healthcare resource utilization, cost to healthcare systems and level of exacerbation risk.