Asthma is a common, chronic disease involving the airways in the lungs. Individuals with asthma have difficulty moving air in and out of their lungs, leading to symptoms such as coughing, wheezing, shortness of breath and/or chest tightness. The mainstays of asthma therapy include inhaled corticosteroids (ICS, anti-inflammatory treatments which prevent inflammation in the airways, minimise reactions to asthma triggers and reduce exacerbations) and inhaled long-acting B2 agonists (LABA, bronchodilator treatments which relax the muscles around the airways, helping to keep them open). For individuals whose symptoms are poorly controlled when using ICS and LABA therapies together, recent guidelines recommend the addition of tiotropium, a different type of bronchodilator called a long-acting muscarinic antagonist (LAMA). Currently, individuals wanting to control their asthma symptoms using this type of newly emerging combination therapy (comprising an ICS, a LABA and a LAMA) must do so using multiple inhaler devices. Few studies have described how patients are initiating this type of triple therapy. Our study intends to explore how patients are prescribed multiple inhaled triple therapy (MITT) in the real world and to describe the characteristics of patients who begin using MITT for the first time, including the burden of their illness.
This retrospective cohort study aims to describe individuals with asthma who initiate multiple inhaled triple therapy (MITT), comprising an ICS, a LABA and a LAMA in England between 2010 and 2017. Two cohorts of patients initiating MITT in primary care will be identified: (a) those who step-up to MITT by adding a LAMA therapy to ongoing treatment with an ICS/LABA fixed dose combination (FDC); and (b), those who step-up to MITT by adding ICS/LABA FDC therapy to ongoing treatment with a LAMA. Key outputs of this study are a description of MITT treatment patterns in the first year after initiation (including discontinuation, adherence and treatment with ICS/LABA or LAMA in the 60 days after discontinuation); and description of patient characteristics and burden of illness in the 12 months prior to the index date (MITT initiation) and the 12 months after the index date. Treatment patterns, patient characteristics and burden of illness will be reported for each cohort. A further four sub-groups will be defined (within each cohort) based on treatment patterns in the first year after initiation of MITT (continuous use, step-down to LAMA, step-down to ICS/LABA and step-down to neither LAMA nor ICS/LABA). Patient characteristics and burden of illness will be additionally described by these four sub-groups. All patients in the study will be required to contribute 12 months of data prior to the index date (initiation of MITT) and 14 months after the index date. The requirement for 14 months post index date is to allow analysis of treatment patterns in the 60 days after discontinuation for those patients who discontinue close to the end of their first year following initiation. Only patients who are eligible for linkage with HES data will be included as HES-APC, HES-A&E, and HES-OP data will be used to classify exacerbations and describe healthcare resource utilisation.
Primary care prescribing of multiple inhaled triple therapy (MITT) comprising a long-acting muscarinic antagonist (LAMA) and an inhaled corticosteroid / long-acting ?2 agonist (ICS/LABA) in two inhalation devices; MITT treatment patterns and adherence; patient demographics; clinical characteristics (including comorbidities); primary care prescribing of asthma medications; asthma exacerbations (managed in primary and/or secondary care); healthcare resource utilisation (including primary care consultations, outpatient appointments, A&E attendance and hospitalisations)
Wilhelmine Meeraus - Chief Investigator - GlaxoSmithKline - UK
Wilhelmine Meeraus - Corresponding Applicant - GlaxoSmithKline - UK
George Mu - Collaborator - GlaxoSmithKline Research & Development Limited (UK)
Leah Sansbury - Collaborator - GlaxoSmithKline - UK
Sandra Joksaite - Collaborator - GlaxoSmithKline Services Unlimited (UK)
Shiyuan Zhang - Collaborator - GSK
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;Patient Level Index of Multiple Deprivation