Chronic obstructive pulmonary disease (COPD) is a chronic, progressive lung disease, which primarily affects those aged 35 years and older and are current/ past smokers. It is estimated that 1.2 million people in the United Kingdom (UK) are living with COPD. There are several treatments available for patients with COPD; however, little is known about real-life treatment patterns and characteristics of patients who start new treatment with combinations of inhalers to control COPD, called triple inhaled therapies. This study will help physicians to understand the characteristics of individuals newly prescribed with inhaled therapies and their frequency of prescription. We will also group patients based on type of medications they are taking at the time of the study to understand how the different available treatments are prescribed over time.
There are several treatments available to manage respiratory symptoms and prevent exacerbations among people with COPD symptoms. The main maintenance pharmacotherapeutic groups include long-acting beta2-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), inhaled corticosteroids (ICS), and their combinations. The effectiveness of these medications vary with patient characteristics, including blood eosinophil counts or prior frequent exacerbations. We propose an observational cohort study using retrospective linked data from CPRD AURUM, Office for National Statistics (ONS) and Hospital Episodes Statistics (HES) data. This study aims to describe the clinical profiles of patients with COPD initiating Triple Therapy (TT) with Budesonide/ Glycopyrronium bromide/ Formoterol fumarate (Trixeo) at the time of launch in the UK. Second, the history of COPD-related healthcare resource utilization (HCRU) and medication use in the 12 months prior to initiation of therapy will be described. HCRU such as hospitalisations will obtained from HES data. Third, prescription abandonment of Trixeo and length of available follow-up of patients initiating Trixeo in CPRD will be assessed to prepare for future studies. The study will then explore the potential for channelling bias in new users of inhaled TTs. The index date will be defined as the date of initiation of TT. All patients fulfilling criteria for COPD diagnosis will be stratified into different cohorts based on the type of therapy initiated at index date. Analysis will focus on the possible presence of channelling bias, also called confounding by indication. Variables considered to evaluate potential confounding will include age, sex, smoking status, spirometry measures, history of dyspnoea etc.. Factors associated with prescription abandonment will be evaluated using Cox proportional hazard regression model. The results of this analysis will be considered when designing future robust future comparative studies to investigate the effectiveness of TT in the real-world setting in the UK.
1. Primary outcomes:
• Demographic characteristics: age at index date, sex, socioeconomic status (or quintile), region;
• Clinical characteristics: Charlson Comorbidity Index (CCI), Body mass index (BMI); Comorbidities; Smoking status; Exacerbations; FEV1 % predicted and FEV1/FVC ratio; Disease symptoms (Medical Research Council [MRC] dyspnoea scores); Blood eosinophil count
• Healthcare resource use (HCRU): General practitioner (GP) visits; Specialist visits; Emergency department (ED) visits; Hospitalizations; Length of stay; Medication use
2. Secondary measures:
• Prescription abandonment of Trixeo;
• Follow-up availability after Trixeo initiation
Ruiqi Zhang - Chief Investigator - AstraZeneca Ltd - UK Headquarters
Ruiqi Zhang - Corresponding Applicant - AstraZeneca Ltd - UK Headquarters
Hana Mullerova - Collaborator - AstraZeneca Ltd - UK Headquarters
Johann Castaneda - Collaborator - Evidera Ltd - UK
Ruiqi Zhang - Collaborator - AstraZeneca Ltd - UK Headquarters
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation