Treatment patterns among new users of maintenance asthma medications in the United Kingdom

Date of ISAC Approval: 
Lay Summary: 
Asthma is one of the most common chronic diseases and is the cause of considerable disability and impaired quality of life across the world. Asthma treatments can be broadly classified as either reliever (generally short-acting bronchodilators) or maintenance therapy (inhaled corticosteroids and long-acting bronchodilators). The goal of asthma management is to achieve and maintain control of symptoms and reduce the risk of future exacerbations with the minimum possible treatment. The Global Initiative for Asthma (GINA) guidelines have been widely adopted and recommend the use of maintenance therapy when asthma symptoms become persistent with adjustments to medication regimes and doses depending on how well a patient's symptoms are controlled. Although studies describing the use of asthma medications at a fixed point in time exist, currently there is limited real-wold information on how patients have their asthma therapies adjusted over time. This study will examine the treatment changes, healthcare contacts and patient characteristics of people with asthma who have newly started maintenance therapy, exploring how treatment are adjusted and provide information on how patients are treated in the real world. In turn, this data may help optimisation and aid the appropriate selection of therapy for people with asthma.
Technical Summary: 
This study will utilise a retrospective cohort. New users of maintenance asthma medication will be identified between January 1, 2013 through December 31, 2015. The first new use prescription for a maintenance medication during this period will be the index prescription. New use will be defined as no prescription for maintenance asthma medication in the 12 months prior to index. New users will be grouped into three cohorts: new use of (1) an inhaled corticosteroid and long acting bronchodilator (ICS/LABA), (2) an ICS, or (3) an oral maintenance medication. Descriptive statistics will be utilized to characterize the cohorts of new users regarding demographics, comorbidities, healthcare resource use, exacerbations, and selected clinical characteristics at index. The index medication will be described by inhaled corticosteroid component and inhalation device where applicable. Treatment patterns in the 24 months (follow-up) after initiation for each cohort, including the most common treatment sequences, time to changes in and discontinuation of therapy. Descriptive statistics will quantify health care resource use and exacerbations during the follow-up.
Health Outcomes to be Measured: 
Healthcare resource utilisation, acute exacerbations of asthma, changes in asthma maintenance therapy.

Dr Daniel Gibbons - Chief Investigator - GSK
Dr Bhumika Aggarwal - Collaborator - GSK
Chanchal Bains - Collaborator - GlaxoSmithKline - UK
Dr Daniel Gibbons - Corresponding Applicant - GSK
Mr David Hinds - Collaborator - GSK
Professor David Price - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Mr Jolyon Fairburn-Beech - Collaborator - GSK
Mrs Monica Fletcher - Collaborator - GSK
Professor Sinthia Bosnic-Anticevich - Collaborator - University Of Sydney