Estimation and characterisation of the potential COPD population for triple therapy combining long-acting muscarinic antagonist, long acting ?2-agonist and inhaled corticosteroid.

Study type
Protocol
Date of Approval
Study reference ID
17_213
Lay Summary

Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable and treatable disease that is characterized by breathing difficulties. Attacks of COPD affect an individual's day-to-day life and COPD is responsible for approximately 5% of all deaths in the United Kingdom. There are different treatments for COPD but it is believed that a treatment combining three different types of drugs (triple therapy) may offer some benefit for certain types of patients. It has been suggested that the patient who would benefit most from this therapy would have increased levels of eosinophils, a type of white blood cell that is used by the body to help fight disease. In this study, we wish to use the Clinical Practice Research Datalink to study a population with COPD, to determine how many of these patients have a sudden attack during one year, and to describe these patients by their levels of eosinophils. We then wish to classify patients between their levels of eosinophils and number of COPD attacks. This study will be important in helping to determine the size of the population with COPD that may benefit from triple therapy.

Technical Summary

Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) is associated with an accelerated decline in lung function, impaired quality of life, hospitalization, and increased mortality. Prevention of exacerbations is a key goal in the management of COPD. The primary objective of the study is to estimate the size of the COPD population who may benefit from triple therapy combining long-acting muscarinic antagonist, long acting beta 2-agonist and inhaled corticosteroid that is, the percentage of COPD patients with ?2 exacerbations in one year and with high blood count levels. Secondary objectives include describing the COPD population by number of exacerbations in the index year, by baseline blood eosinophil levels and by cross-tabulating exacerbations with a) eosinophil levels and b) forced expiratory volume (FEV1) levels. We aim to use CPRD database to study a population with COPD in two different cohort years. We then aim to classify these patients by level of eosinophils and both prior and subsequent exacerbations in order to present this data in a tabular format.

Health Outcomes to be Measured

Segmentation of COPD population; Exacerbations of COPD.

Collaborators

Juanzhi (Jenny) Fang - Chief Investigator - NOVARTIS
Bethan Jones - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences

Former Collaborators

Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;Patient Level Index of Multiple Deprivation