Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable condition of the lungs. Patients with COPD experience various symptoms including shortness of breath, coughing and wheezing.
There are a broad range of drugs available for the treatment of COPD in the UK, some of which are used to manage a short-term worsening of symptoms (termed “short-acting”) and others which are used daily to prevent symptoms over an extended period of time (termed “long-acting maintenance”). Long-acting maintenance therapies can be prescribed as a single inhaled drug, however, patients who continue to experience episodes of worsening symptoms (called “flare ups”) are recommended to switch to a combination of two types of drugs ( termed ‘’dual’’ therapy), or three types of drugs (termed ‘’triple’’ therapy) if dual therapy isn’t effective at preventing the flare ups. Dual and triple therapies can be given in a single device instead of having each type of drug given in a separate device (i.e. as 2 or 3 devices). This helps simplify the management of COPD and increases the chance of patients taking their long-acting maintenance therapy as they should be taken, a concept known as adherence.
This study aims to describe demographic and health characteristics of patients newly prescribed single device dual/triple therapy as well as short- and/or long-acting treatments prescribed prior to dual/triple therapy. Moreover, this study aims to describe use and cost of healthcare services, frequency and timing of flare-ups, and adherence to therapy following initiation of dual/triple therapy.
Aim: To describe the characteristics of patients with COPD newly initiating single device dual or triple maintenance therapy in UK clinical practice. . A stronger understanding of the demographics, clinical outcomes, and treatment patterns of these patients will inform future comparative effectiveness research and ultimately aid clinical decisions that improve patient outcomes.
Objectives: To describe i) sociodemographic/clinical characteristics, ii) COPD treatments previously received, among COPD patients newly initiating single device dual or triple therapy, by therapy regimen, drug class and product. Clinical endpoints post-initiation will also be described in these patients. Sociodemographic/clinical characteristics will also be described for patients initiating single device dual/triple therapy as initial maintenance therapy.
Methods: A longitudinal cohort study of COPD patients newly initiating single device dual or triple therapy between Nov-2017 and Sep-2019 (indexing period), using linked retrolective primary (Clinical Practice Research Datalink [CPRD] Aurum) and secondary care (Hospital Episode Statistics [HES] Admitted Patient Care [APC], Outpatient [OP] and Accident and Emergency [A&E] datasets) data. The first/earliest treatment prescription date of a dual or triple therapy during the indexing period will determine the index date. A minimum of 12 months pre-index data and 6 months follow-up are required for study inclusion.
Primary exposure: Single device non-Ellipta dual therapy (LAMA/LABA or ICS/LABA), or FF/UMEC/VI single inhaler triple therapy.
Outcomes: Patient characteristics, prior COPD treatments, exacerbations, triple therapy (for patients indexed on dual therapy only), medication adherence, persistence, HCRU/costs.
Data analysis: Counts, means, medians, standard deviation, 25th and 75th percentile values will be reported for numeric variables, whilst relative frequencies and proportions/percentages will be reported for categorical variables. Rates will be reported for outcomes assessed over variable follow-up, i.e. number of events/person-years (or per-patient per-month for cost outcomes) with accompanying 95% confidence intervals. Kaplan-Meier estimates will be reported for time-to-event analyses, including median survival time, where reached.
Acute exacerbations of COPD (AECOPDs; moderate/severe, moderate and severe); Time-to-first on-treatment AECOPD (moderate/severe, moderate and severe); Time-to-triple therapy (multiple or single inhaler triple therapy); Adherence to dual/triple therapy (using PDC as a categorical and continuous metric); Persistence to dual/triple therapy; Demographics (e.g. age and sex); Clinical characteristics (e.g. spirometry); Healthcare resource utilisation (all cause and COPD-related); Direct medical costs (all-cause and COPD-related).
Stephen Noorduyn - Chief Investigator - GSK
Monica Seif - Corresponding Applicant - Adelphi Real World
Afisi Ismaila - Collaborator - GSK
Beade Numbere - Collaborator - GSK
Kieran Rothnie - Collaborator - GlaxoSmithKline Services Unlimited (UK)
Kiran Rai - Collaborator - Adelphi Real World
Lucy Massey - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;Patient Level Index of Multiple Deprivation