Asthma is a chronic condition caused by inflammation of the airways which can lead to symptoms such as wheezing, breathlessness and coughing. Asthma can reduce a patients quality of life and increase the burden on health services due to a higher number of general practice and hospital visits. When a patient is exposed to a certain triggers such as pollen, cold air or a chest infection, there is an increased risk of an asthma attack known as an exacerbation. This can vary in severity but can lead to the patient being admitted to hospital or may even be life-threatening. Controlling a patients asthma is therefore a key goal of disease management guidelines. The Global Initiative for Asthma Guidelines (GINA) is an international body which aims to reduce symptoms and exacerbations for patients with asthma. They recommend a series of different medicines that patients should try until their asthma is controlled. The purpose of this study is to investigate how two different medicines recommended by the GINA guidelines compare when added to a patients treatment. To do this we wish to select patients taking each medicine in the Clinical Practice Research Datalink and see how long they remain on that medicine before either another medicine needs to be added to their treatment to control their symptoms or they have an exacerbation.
Uncontrolled patients with asthma typically have worse health outcomes and a lower quality of life. The aim of this study is to characterize the effect an additional controller being added to a patients treatment has in relation to their time to treatment failure. The study will also report the frequency of exacerbation events, healthcare utilization, and investigate potential predicting factors in patients with additional controllers added. The Clinical Practice Research Datalink (CPRD) linked with Hospital Episode Statistics (HES) will be used to identify asthmatic patients. Patients on medium dose inhaled corticosteroids (ICS) in combination with long-acting ß2 agonist (LABA) will be investigated to examine two cohorts of uncontrolled asthmatic patients; Patients who titrated up to a high dose ICS/LABA compared to patients who had a LAMA added to their medium ICS/LABA treatment. Both adult and adolescent patients will be included in this study and analysed in combination and separately. Cox regression models and Kaplan Meiers will be used for the primary endpoint of time to treatment failure for both cohorts. Index date will be set as the date additional controller is added, either high ICS or LAMA depending on cohort.
Treatment failure; Time to exacerbation; exacerbation rates; healthcare resource use
Raymond Przybysz - Chief Investigator - NOVARTIS
Patrick Ward - Corresponding Applicant - Novartis Ireland Limited
Abhishek Srivistava - Collaborator - NOVARTIS
Anas Al Zabiby - Collaborator - NOVARTIS
Bethan Jones - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Thomas Berni - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation