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.
A combination of three types of drug (termed ‘triple therapy’) taken as two or three separate inhalers has been used to treat the most severe patients with COPD for many years, particularly for preventing “flare ups” in symptoms called exacerbations. However, the use of multiple inhalers can be complex and may be cumbersome for patients. This can result in patients not taking the medication according to how they should be taken, a concept known as adherence, resulting in worsening symptoms and increased exacerbations. Therefore, single inhaler triple therapies (SITTs) have recently been developed whereby the three drugs are combined into a single inhaler and introduced to improve adherence and reduce the burden of use on patients.
This study aims to see whether there are any differences in patient outcomes when starting patients with COPD on one of the currently available SITTs versus multiple inhaler triple therapy (MITT). This will include comparing the number of patients with an exacerbation, the number of exacerbations in the 6 and 12 months following starting on these treatments, as well as the need for other healthcare services and the associated costs to the National Health Service. Findings from this study may indicate that using this SITT could help to reduce the burden of COPD on both patients and the healthcare system.
Aim: To assess the impact of initiating triple therapy with single inhaler Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) versus MITT by comparing rate of acute exacerbations of chronic obstructive pulmonary disease (AECOPDs), healthcare resource utilisation (HCRU) and medical costs among COPD patients in a General Practice cohort in England. Greater understanding of the effectiveness of these therapies will better-inform treatment choices for COPD patients.
Objectives: To compare i) rate of AECOPDs ; ii) all-cause and COPD-related HCRU/costs among COPD patients newly initiating triple therapy with MITT versus single inhaler FF/UMEC/VI. Rate of AECOPDs will also be compared between patients initiating MITT and single inhaler FF/UMEC/VI who are new to the ICS molecule(s) and with any prior therapy, and will also be evaluated in COPD patients newly initiating triple therapy (MITT versus single inhaler FF/UMEC/VI) with and without a diagnosis of comorbid asthma.
Exposures: Single inhaler FF/UMEC/VI and MITT initiation
Outcomes: Rate of AECOPDs (moderate-to-severe; moderate; severe); HCRU; Direct medical costs
Methods: A new-user, active comparator, retrospective cohort study using inverse probability of treatment weighting (IPTW) to adjust for measured confounders to assess the superiority of single inhaler FF/UMEC/VI versus MITT using linked CPRD Aurum and Hospital Episode Statistics (HES) data. The first/earliest date of triple therapy (MITT or single inhaler FF/UMEC/VI) initiation between 15th November 2017 and 30th September 2019 will determine the index date. The minimum required follow-up is 6 months.
Analysis: A propensity score (PS) method will be implemented to minimise potential confounding and evaluate average effects in the population. Logistic regression will generate the PS, which will be applied via IPTW. Rate of AECOPDs (events per person-year) will be compared using weighted rate ratios (RRs) from negative binomial regression. HCRU and costs will be compared using weighted RRs from negative binomial regression and relative rates from generalised linear model, respectively.
Rate of AECOPD (moderate-to-severe, moderate, severe); HCRU (all-cause and COPD-related); Direct medical costs (all-cause and COPD-related).
Kieran Rothnie - Chief Investigator - GlaxoSmithKline Services Unlimited (UK)
Victoria Banks - Corresponding Applicant - Adelphi Real World
Afisi Ismaila - Collaborator - GSK
Alexandrosz Czira - Collaborator - GlaxoSmithKline Services Unlimited (UK)
Lucinda Camidge - Collaborator - Adelphi Real World
Monica Seif - Collaborator - Adelphi Real World
Olivia Massey - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
HES Accident and Emergency;HES Admitted Patient Care;Patient Level Index of Multiple Deprivation