Patient and clinical characteristics of new users to single or multiple inhaled triple therapy in patients with COPD in the UK

Date of ISAC Approval: 
Lay Summary: 
Chronic Obstructive Pulmonary Disease (COPD) is the third most common cause of death. The main complaints of patients with COPD are breathlessness and a productive cough, and COPD patients often have periods where their symptoms worsen. The goals of COPD treatment are to reduce symptoms, reduce the periods of worsening of symptoms (called exacerbations), and improve health status and exercise tolerance. Currently, COPD patients are treated with drugs that open airways or reduce inflammation in the lung. For patients with severe disease, a combination of two or three types of drugs is recommended. In recent years, there has been an increase in the use of a combination of three different types of drugs called triple therapy. Triple therapy may either consist of a combination of three different drugs in several inhalers (multiple inhaled triple therapy) or in a single inhaler (single inhaled triple therapy). Few studies have reported on the characteristics of patients initiating this newly emerging combination treatment. Thus, this study aims to describe the characteristics of patients using single inhaler or multiple inhaler triple therapy for COPD patients in a primary care setting.
Technical Summary: 
The objective of this study is to characterize a cohort of COPD patients who initiate an inhaled triple regimen for the first time between Nov 2017-Nov 2018, either as: 1) Single inhaled triple therapy (SITT) (LAMA+LABA+ICS delivered in a single inhaler) or; 2) Multiple inhaled triple therapy (MITT) (LAMA+LABA+ICS by either using three separate therapies or a monotherapy coupled with a fixed combination dual therapy). In a cohort of COPD patients who were actively registered in CPRD practices, we will describe patient characteristics in the prior to initiation of inhaled triple therapy for the first time. Patient characteristics will include sociodemographics, comorbidities, COPD burden (including recent COPD exacerbations, degree of airflow limitation, and MRC breathlessness score), prior medication use, and recent healthcare resource utilisation. We will use linked HES admitted patient care data to identify hospitalised exacerbations of COPD, and HES outpatient data to ascertain recent secondary care healthcare resource utilisation. This is a cross-sectional descriptive study, and we will not follow up patients for health outcomes following initiation of inhaled triple therapy.
Health Outcomes to be Measured: 
Patient demographics; Respiratory history and disease severity; Respiratory medications; Healthcare resource utilisation (including rates of primary-care consultations and unscheduled, non-COPD-related hospitalisations).

Kieran Rothnie - Chief Investigator - GlaxoSmithKline - UK
Dr Afisi Ismaila - Collaborator - GSK
Kieran Rothnie - Corresponding Applicant - GlaxoSmithKline - UK
Leah Sansbury - Collaborator - GlaxoSmithKline - UK
Miss Sandra Joksaite - Collaborator - GlaxoSmithKline - UK

HES Admitted;HES Outpatient;Patient IMD