Real-world comparative effectiveness of Fluticasone Furoate+Umeclidium+Vilanterol versus multiple inhaler triple therapies among patients with Chronic Obstructive Pulmonary Disease in the United Kingdom

Date of Approval
Application Number
Technical Summary

Aim: To assess the impact of initiating triple therapy with single inhaler Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) versus multiple inhaler triple therapy (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 choice for patients with COPD.

Objectives: To compare i) rate of moderate-to-severe AECOPDs (also moderate and severe separately); ii) all-cause and COPD-related HCRU and direct costs among COPD patients newly initiating triple therapy with MITT versus single inhaler FF/UMEC/VI. Rate of moderate-to-severe AECOPDs (also moderate and severe separately) 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 (derived via application of unit costs/tariffs) will be compared using weighted RRs from negative binomial regression and relative rates from generalised linear model, respectively.

Health Outcomes to be Measured

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 - UK
Victoria Banks - Corresponding Applicant - Adelphi Real World
Afisi Ismaila - Collaborator - GSK
Alexandrosz Czira - Collaborator - GSK
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