Rationale:
Asthma is a common multifactorial disease with chronic inflammation of the lower airways,
which is in most cases adequately treated by inhalation medication. 17% of asthma
patients have difficult-to-treat asthma, which is uncontrolled despite of an optimal
treatment with medication due to the presence of 'treatable traits'. Examples of
treatable traits are poor adherence to ICS/LABA therapy and inhaler technique,
dysfunctional breathing, physical inactivity and behavior. Severe and refractory asthma
is a subtype of difficult-to-treat asthma and only occurs if the asthma is uncontrolled
despite optimized treatment with medication and addressing of treatable traits, which
occurs in only 3.7% of all asthma patients. This group of patients is responsible for a
high burden of overall disease, as well as large healthcare costs.Treatment options with
biologics have fundamentally changed the care for patients with severe asthma by giving a
relevant improvement in asthma control, the number of asthma exacerbations and quality of
life. On the other hand, these drugs are also very expensive and must be given for the
correct indication.
The Centre of Excellence for severe Asthma, Franciscus Gasthuis & Vlietland, Rotterdam
organizes a weekly Multi-Disciplinary Team Meeting (MDTM) for hospitals in the South-West
of the Netherlands to discuss their patients with problematic asthma and to start a
treatment with biologics approved for severe asthma (in this document further called
biologics). Despite maximal efforts of all stakeholders, the complete overview of a
patient and the treatable traits is often hampered by the complexity and heterogeneity of
severe asthma.
The aim of the EXACT@Home (Expertise Asthma COPD program with digital support) study is
to further improve the assessment of treatable traits using ehealth before considering
treatment with biologics.
Objectives:
Primary objective: To investigate if the EXACT@home program results in a reduced
percentage of patients treated with biologics by means of systematically targeting
treatable traits measured after 6 months of follow up.
Secondary objectives: To determine whether the use of EXACT@home results in a reduced
percentage of patients treated with biologicals after 11-12 months. Next to this it will
be investigated if EXACT@home has an influence on quality of life, asthma control,
dyspnea perception, lung function, exacerbation frequency, prednisolone use, direct
healthcare consumption, self-management skills, patient satisfaction, adherence to
ICS/LABA therapy and inhaler technique, physical activity, sleep and vital parameters.
Next to this, breath pattern analysis will be performed with the electronic nose (eNose).
Moreover, the safety of the Digital inhaler (BF-Digihaler-DS from Teva) and eNose
(Spironose from Breathomix) and the course of the treatment in each patient will also be
investigated.
Study design:
Open-label, randomized controlled trial with a superiority design.
Study population:
Patients aged ≥ 18 years, in which the diagnosis severe and refractory asthma and
eligibility for treatment with biologics was determined at the regional asthma MDTM will
be asked to participate in this project.
Intervention (if applicable):
Patients will be randomized in 2 groups (intervention - and control group). The
intervention group participates in a holistic assessment called EXACT@home consisting of
a period of 6 weeks addressing diagnosis, asthma phenotype and treatable traits using
e.g. questionnaires and digital devices measuring airway obstruction, eosinophilic airway
inflammation, adherence to ICS/LABA therapy, inhalation technique, movement, vital
parameters and sleep. The information of the devices and all other information concerning
the patient will be stored in an 'Personal Digital Healthcare Environment (PDHE)'.
Afterwards the collected data will be evaluated. Based on this evaluation and the degree
of asthma control the type of treatment will be determined: optimization of 'treatable
traits' or start of treatment with biologics. The control group will immediately start
the treatment with biologics. The chosen treatment of both, the intervention and control
group, will be evaluated during 11-12 months.
Main study parameters/endpoints:
Study parameter primary outcome:
Difference between the intervention and control group in the percentage of patients
treated with biologicals after 6 months of follow up.
Study parameters secondary outcome:
The percentage of patients treated with biologicals after 11-12 months of follow up,
quality of life, asthma control, dyspnea perception, lung function, exacerbation
frequency, prednisolone use, direct healthcare consumption, self-management skills,
patient satisfaction, adherence to ICS/LABA therapy, inhaler technique, physical
activity, slap, vital parameters, breath pattern analysis with the eNose, safety of the
digital inhaler and eNose and the course of the treatment in each patient.
Nature and extent of the burden and risks associated with participation, benefit and
group relatedness:
The possible burden of the intervention group is temporarily postponing an effective
treatment with biologics in favour of in depth extensive assessment in patients with a
severe disease for a short period of at least 6 weeks. On the other hand, the patient
could benefit from the EXACT@home assessment possibly leading to a personalized
treatment, in which a treatment with biologics might not be necessary anymore. Next to
this, another possible minor burden is 1 extra visit in addition to standard care.