Triple therapy convenience by the use of one or multiple inhaler and digital support in Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a common, chronic lung disease
and is associated with high morbidity and mortality. Pharmacologic treatment
often involves multiple classes of inhaled medication that have been proven
effective in clinical trials. However, the effectiveness of treatment with
inhaled medication in the real-world is strongly influenced by medication
adherence. In previous studies, it was shown that adherence rates in COPD
patients are low and that nonadherence is related to poor clinical outcomes.
Nonadherence is caused by many different factors, including the type of inhaler
device(s) being used. Notably, the use of multiple different types of inhalers
could increase the risk of inhaler errors and poor adherence. Our hypothesis is
that simplifying the treatment by single-inhaler triple therapy instead of
multi-inhaler triple therapy will positively influence the adherence to
inhalation medication. Furthermore, we hypothesize that the adherence improves
if patients use an e-device with feedback system and supportive e-health
platform.

The primary objective of this study is to investigate if single-inhaler triple
therapy (SITT, in this study Trimbow®) is superior to multi-inhaler triple
therapy (MITT, in this study Bevespi® and Qvar®) in terms of adherence to
inhaled corticosteroids (ICS) therapy (average adherence measured by an
e-device) over 12 months of treatment and to investigate if SITT with e-health
support is superior to MITT and SITT without e-health support in terms of
adherence to ICS therapy.

Secondary objectives are:
- Validation techniques to measure adherence: actuations e-device vs TAI
questionnaire vs hair analysis (beclomethasone and/or formoterol)
- to investigate link between adherence and clinical outcomes.
- to investigate if the adherence after a recent exacerbation differs from the
adherence during stable disease

The study is a investigator initiated, prospective, interventional, open-label,
randomized, real-world, multi-centre, 3-arms study

The first group will receive multi-inhaler triple therapy (control group), the
second group single-inhaler triple therapy (intervention group 1) and the third
group single-inhaler triple therapy with extra digital support to increase
therapy adherence (intervention group 2). The digital support consists of an
e-device connected to an app and e-health platform, including reminders, extra
insight in disease progression and e-consults with the healthcare practitioner

In usual care, COPD patients visit the hospital three times each year. The
visits for this study are simultaneously with the standard care, however
spending a longer time in the hospital for completing questionnaires, lung
function and hair donation can be cumbersome to the patients. They will be
asked to fill out nine questionnaires/scores at three different time points,
will be submitted to a lung function two times and hair will be collected at
one occasion.
All patients will receive triple therapy. The patients included in this study
are indicated to standard care triple therapy and consequently not subject to
additional side effects, discomfort or risks. The use of the app may be
experienced as burdensome by patients, but is expected to be not very
stressful. The study will have as little as possible further interventions, in
order not to influence medication adherence and make the study most comparable
to the real world.