TARGET-EU: Comparison of single-device vilanterol/fluticasone furoate with other single-device inhaled corticosteroid and long-acting beta agonist combinations in the risk of pneumonia in adolescents with asthma

22/05/2026
22/05/2026
EU PAS number:
EUPAS1000000989
Study
Planned
Subscribe
Download as PDF
Study summary
No information provided.
Study identification

EU PAS number

EUPAS1000000989

Study ID

1000000989

Official title and acronym

TARGET-EU: Comparison of single-device vilanterol/fluticasone furoate with other single-device inhaled corticosteroid and long-acting beta agonist combinations in the risk of pneumonia in adolescents with asthma

DARWIN EU® study

No

Study countries

Belgium
Finland
Netherlands
United Kingdom

Study description

This case study is part of the broader TARGET EU project (EUPAS1000000539), which aims to advance the regulatory use of real-world data through the application of target trial emulation and estimand methodologies.
Background:  Higher pneumonia rates for patients on vilanterol-fluticasone furoate (V+FF) treatment in comparison to inhaled corticosteroids (ICS) have been reported in trials on adolescent and asthma patients, but there are no estimates on pneumonia risk in adolescents with asthma. It is not known whether the V+FF combination pertains to higher pneumonia risk than other single device inhaled corticosteroid+long-acting beta adrenoceptor (LABA) agonist treatments.
Objective We evaluate the risk of pneumonia in V+FF initiators in comparison to other ICS+LABA single-device treatments in representative real-world settings among adolescents with asthma who are already on ICS treatment.
Methods: We will conduct an active comparator new-user cohort study using linked electronic health records from 2014 to 2023. The study is set primarily in primary care, drawing on longitudinal data from general practices with linkage to hospital data. Data are sourced from two European countries, the United Kingdom (Clinical Practice Research Datalink [CPRD]) and Finland (Finnish national registries), providing population-based and representative coverage of real-world clinical care. In the primary analysis we estimate HR of pneumonia for V+FF vs. other ICS+LABA combination in adolescent asthma patients who were on ICS treatment within the year preceding the initiation, alive and on treatment (i.e., before treatment discontinuation or switching to Other ICS+LABA combination), regardless of using other add-on or rescue medications. Inverse probability of treatment weighted (IPTW) Cox regression is used to estimate treatment effects in the primary analysis. Supplemental analyses using an accelerated failure time model are conducted.

Study status

Planned
Research institutions and networks

Institutions

Teamit Institute
Spain
First published:
12/03/2024
Institution Other ENCePP partner
Ghent University (Belgium)

Networks

Contact details

Anna-Maija Tolppanen 0000-0001-9270-9268

Primary lead investigator
ORCID number:
0000-0001-9270-9268

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable