Prescribing Pathways to Triple Therapy in Chronic Obstructive Pulmonary Disease

Date of ISAC Approval: 
Lay Summary: 
Chronic obstructive pulmonary disease (COPD) is a very common lung condition which causes breathing difficulties. Combinations of three medications (triple therapy) are often recommended to control symptoms. Patient response to treatment is related to how well they take their medication as recommended (known as adherence). However, little is currently known about the course of treatments patients may take before triple therapy (treatment pathways), how this relates to adherence, and the effect on the patient's health. This study aims to understand the type of treatment COPD patients may receive. As COPD symptoms worsen, medications prescribed are likely to change. Patients may also seek advice or care from their GP or hospital when experiencing symptoms, which will also be examined. Treatment changes and lab tests relevant to COPD will also be described. Results from this study will give insight into factors influencing treatments for COPD.
Technical Summary: 
This study will examine pathways to triple therapy in COPD and how patient factors (such as exacerbations and symptom score) influence treatment pathways. Adherence will be assessed and evaluated in relation to exacerbation and healthcare resource utilisation. Changes in therapy and eosinophil levels will also be ascertained. COPD cases, approximate disease severity, symptom score, and exacerbations will be identified from proxy indicators due to known issues relating to data completeness[1,2]. The number and proportion of patients on triple therapy and on distinct pathways will be determined. Time to first prescription will be estimated using Kaplan-Meier survival analysis and reported as cumulative proportions alongside the survival curve. The influence of factors (number of exacerbations, symptom score, lung function, phenotype) on choice of pathway leading to triple therapy will be initially explored using bivariate analyses (e.g., comparisons of means, medians or proportions as appropriate between different pathways). A multinomial logistic regression model may be employed as a multivariable analysis of factors predicting pathways. The analysis of pathways of stepping down from triple therapy after initiation will include proportion (%) with 95% confidence intervals and Kaplan-Meier survival analysis of time to stepping down.
Health Outcomes to be Measured: 
- COPD exacerbations - Adherence - Healthcare resource utilization - treatment pathways

Dr Joseph Kim - Chief Investigator - IQVIA - UK
Alessandra Venerus - Collaborator - IQVIA - UK
Caroline O'Leary - Collaborator - IQVIA - UK
Dr Claudia Cabrera - Collaborator - Astra Zeneca R&D Molndal Sweden
Gianluca Lucrezi - Collaborator - IQVIA (IMS Health) France
Dr Hans Petri - Collaborator - Petri Consulting Ltd
Dr Jennifer Quint - Collaborator - Imperial College London
Kieran Rothnie - Collaborator - GSK
Melissa Myland - Corresponding Applicant - IQVIA (IMS Health) France
Ms Rachel Tham - Collaborator - IQVIA - UK
Shaila Ballal - Collaborator - Pearl Theraputics
Ulf Holmgren - Collaborator - Astra Zeneca Inc - USA

HES A&E;HES Admitted;ONS;Patient IMD