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 wide range of drugs that are available for the treatment of COPD in the UK. To help prevent “flare-ups” in symptoms (called exacerbations), patients are usually given inhaler treatments which contain a combination of two types of drug (termed “dual therapy”), taken together as part of a single inhaler and used daily to prevent symptoms over an extended period of time (termed “long-acting”).
This study aims to describe the patients receiving long-acting dual therapy for COPD in the UK and their disease characteristics. We will also describe the range of different inhaler treatments which they receive as well as reporting the use and costs associated with the healthcare provided to them. Moreover, as part of this study we will describe how often patients on dual therapy for COPD have exacerbations and at which point in their treatment do their symptoms become so severe they are required to ‘step up’ their treatment from dual to triple therapy (inhaler combinations of three different drugs given to patients with the most severe of symptoms). Lastly, we will describe to what extent patients take their dual therapy inhalers as they should be taken, a concept known as adherence, and how often patients stop their dual therapy treatment to switch to other types of treatment.
Aim: To describe the demographic and clinical characteristics of patients with COPD receiving single-inhaler dual therapy and to assess key clinical outcomes following initiation of these therapies.
Objectives: i) to describe sociodemographic and clinical characteristics of all single-inhaler dual therapy users ii) to describe the duration and sequence of treatments prior to and post initiating single-inhaler dual therapy iii) to describe healthcare resource utilisation (HCRU) and costs pre and post single-inhaler dual therapy initiation iv) to describe clinical outcomes (exacerbations, uptake of triple inhaler therapy, medication adherence and persistence) following initiation of single inhaler dual therapies.
Primary exposures: Single-inhaler dual therapy.
Outcomes: Sociodemographic and clinical characteristics; Treatment pathways; Direct medical costs; HCRU; Rate of moderate-to-severe exacerbations (AECOPD); Time-to-first AECOPD; Time-to-triple therapy; Medication adherence and persistence.
Methods: A retrospective cohort study of COPD patients receiving single-inhaler dual therapy between June 2015 and December 2018 (indexing period), using linked primary and secondary care administrative data. The index date will be defined as the date of the first prescription of single-inhaler dual therapy during the indexing period. A minimum of 12 months data prior to the index date will be required for inclusion into the study, during which baseline sociodemographic characteristics, clinical characteristics, treatment use/ patterns and HCRU/ costs will be described. Outcomes will be assessed at discrete time intervals (3, 6, 9, 12 months) post dual therapy initiation.
Data analysis: Counts, means, medians, standard deviation, 25th and 75th percentile values will be reported for numeric variables and relative frequencies, proportions/ percentages for nominal variables. HCRU and costs will be derived by observing consultations and medications in primary care, and Healthcare Resource Group for secondary care. Adherence will be classified using proportion of days covered (PDC) [PDC<80% representing non-adherence]. Persistence, time-to-first exacerbation, and time-to-triple therapy will be assessed using Kaplan Meier survival analysis.
Rate of moderate-to-severe exacerbations; Time-to-first on-treatment moderate-to-severe exacerbation; Time-to-triple therapy use (in multiple and single devices); Adherence to single device dual inhaler therapy (via PDC); Persistence to single device dual inhaler therapy (time from treatment initiation to discontinuation); Treatment pathways prior to and following single device dual inhaler therapy initiation; All-cause and COPD-related healthcare resource utilisation; All-cause and COPD-related direct medical costs
Gema Requena - Chief Investigator - GlaxoSmithKline Services Unlimited (UK)
Victoria Banks - Corresponding Applicant - Adelphi Real World
Afisi Ismaila - Collaborator - GSK
Alexandrosz Czira - Collaborator - GlaxoSmithKline Services Unlimited (UK)
Eunmi Ha - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
Rosie Wild - Collaborator - Adelphi Real World
Stuart Blackburn - Collaborator - Adelphi Real World
Theo Tritton - Collaborator - Adelphi Real World
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;Patient Level Index of Multiple Deprivation