The aim of the EXACT@Home study is to further improve the assessment of treatable traits in patients with difficult to treat to severe asthma using ehealth before considering treatment with biologics.
ID
Source
Brief title
Condition
- Other condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Health condition
Onderste luchtwegaandoeningen: inflammatie en obstructie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference between the intervention and control group in the percentage of
patients treated with biologicals after 6 months of follow up.
Secondary outcome
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, sleep, vital parameters, breath pattern
analysis with the eNose, safety of the BF-Digihaler-DS (digital inhaler) and
SpiroNose (eNose) and the course of the treatment in each patient.
Background summary
Asthma is a common multifactorial disease with chronic inflammation of the
lower airways. Asthma is in most cases adequately treated by inhalation
medication. However, there is subgroup of patients which have uncontrolled
asthma, consisting of poor symptom control and frequent asthma exacerbations.
17% of asthma patients have difficult-to-treat asthma, which is uncontrolled
despite of treatment with a medium to high dose ICS (inhaled corticosteroids)
in combination with a LABA (long acting beta 2 agonists) or with maintenance
OCS (oral corticosteroids). This type of asthma often appears to be difficult
to treat because of the presence of treatable traits. Examples of treatable
traits are poor adherence to inhalation therapy and inhaler technique,
dysfunctional breathing, exposure to toxic substances and/or allergens,
contraindicated medication, co-morbidities, excess weight, working conditions,
reduced exercise capacity, 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 inhaler therapy and
addressing of treatable traits. Only 3.7% of all asthma patients have this type
of asthma. However, this group of patients is responsible for a high burden of
overall disease, as well as large direct and indirect costs.Treatment options
with biologics have fundamentally changed the care for patients with severe
asthma. These drugs give a relevant improvement in asthma control, the number
of asthma exacerbations and quality of life. 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 offers a weekly Multi-Disciplinary Team Meeting (MDTM) for hospitals
in the South-West of the Netherlands to discuss their patients with problematic
asthma. Despite maximal efforts of all stakeholders, the complete overview of a
patient and thereby the presence of treatable traits is hampered by the
complexity and heterogeneity of severe asthma. Franciscus Gasthuis & Vlietland
offers a validated tertiary assessment to address treatable traits in detail.
To further optimize this integrated care assessment, eHealth applications with
home monitoring tools will be added to the program: EXACT@home project
(Expertise Asthma COPD program with digital support).
The aim of the EXACT@Home project is to create an evidence-based health program
using eHealth and multiple digital devices to further improve the assessment of
patients with diffcult to treat to severe and refractory asthma before starting
with a treatment consisting of biologics.
We hypothesize that by using the EXACT@home, it is possible to identify and
treat even more specifically the underlying *treatable traits* of asthma. This
makes the treatment more targeted, prevents unnecessary or even incorrect
prescription of biologics and possibly saves costs.
Study objective
The aim of the EXACT@Home study is to further improve the assessment of
treatable traits in patients with difficult to treat to severe asthma using
ehealth before considering treatment with biologics.
Study design
Open-label, randomized controlled trial with a superiority design.
Intervention
Patients with severe asthma who are eligible for treatment with biologics
(determined at the regional asthma Multi-Disciplinary Team Meeting (MDTM)) will
be included. 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. 4 or 5 digital devices will be used:
1. A Hand-held spirometer to measuring airway obstruction: Spirobank Oxi from
MIR;
2. A smart inhalation device with it's own application to monitor adherence to
inhalation therapy and inhaler technique): Budesonide/Formoterol electronic
multidose dry powder inhaler (BF-Digihaler) Digital System (-DS) from Teva;
3. An activity tracker with initially it's own application to measure physical
activity, vital parameters and sleep): Cardiowatch 287-2 from Corsano.
4. A Fraction of Expired Nitric Oxide (FeNO) measurement device. FeNO is a
surrogate marker for eosinophilic airway inflammation: Vivatmo me from Bosch.
This medical device will only be used in a subgroup of patients with FeNO >45
ppb;
5. During the last week of the 6 weeks patients also receive a second activity
tracker according to standard care: DynaPort MoveMonitor from McRoberts.
The information of the Spirobank Oxi, the Vivatmo me and eventually the
Cardiowatch 278-2, questionnaires and all other information concerning the
patient will be stored in the *Personal Digital Healthcare Environment (PDHE)*
of Curavista, to which the patient and caregiver have access. The PDHE also
contains an online self-management diary for the patient. The application of
Corsano will initially be used for Cardiowatch 287-2 instead of the PDHE,
because the connection between the Cardiowatch 287-2 and the PDHE needs to be
further developed. before the PD. De BF-Digihaler from Teva has its own
application in which that patient can view his/her results and the application
can also give reminders/notifications on the usage of the BF-Digihaler. De data
of the BF-Digihaler DS is also accessable for both the patient and the
caregiver. After collecting all data, there will be an evaluation of the data
extracted from the EXACT@home systematic anamnesis, questionnaires and devices.
Based on this evaluation and the degree of astma control, the type of treatment
will be determined: optimization of *treatable traits* or start of the
treatment with biologics as previously determined at the regional asthma MDTM.
The control group will immediately start a treatment with biologics after
eligibility is determined at the regional asthma MDTM. In addition, the control
group will also use the BF-Digihaler (but without the application, which means
these patients don't have insight into their own results and will not recieve
reminders en notifications) and the PDHE. The chosen treatment of both, the
intervention and control group, will be evaluated during 11-12 months of which
the primary endpoint is after 6 months. During this follow up the chosen
treatment can be amended or ceased. It is possible for the intervention group
to eventually add a biologic during this period when a treatment of treatable
traits was first chosen. In addition, both the patients in the intervention and
control group will undergo an analysis of volatile compounds in the exhaled
breath with an electronic nose (SpiroNose from Breathomics) at the beginning
and the end of the study to measure the difference before and during treatment
(biologicals).
Study burden and risks
The possible burden of the intervention group is that an effective treatment
with biologics is temporarily postponed in favour of in depth assessment for a
short period of 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, there
are other possible minor burdens. For example 1 extra visit in addition to
standard care. Next to this, blood samples have to be drawn during the study
(standard practice) and a urine analysis (cotinine) will be performed during
visit 1. Also, lung function measurements have to be performed (standard
practice), which takes approximately 30-45 min each time. Furthermore,
questionnaires have to be completed (from which a part is standard practice).
During the first visits all questionnaires will be filled in which takes
approximately 45-50 minutes for the intervention arm and 30 minutes for the
control arm. During the following visits a smaller amount of questionnaires
will be completed. Additionally, measurements of exhaled breath with the
elektronic nose will be performed, which takes approximately 2-3 minutes each
time. In addition, patients in both groups will use Curavista's Personal
Digital healthcare environment (PDHE) for 11-12 months. Moreover, patients in
the intervention group will have to use the Spirobank Oxi, Vivatmo me and
Cardiowatch 278-2 for a period of 12 weeks. In addition, the BF-Digihaler-DS
has to be used for 11-12 months in the intervention and the control group. The
patient will use the Spirobank Oxi and Vivatmo me every day. The
BF-Digihaler-DS substitutes the patient*s own inhaler medication. The
Cardiowatch 287-2 will be worn around the wrist and the Dynaport MoveMonitor
will be worn around the waist, both for 24/hours a day.
Kleiweg 500
Rotterdam 3045 PM
NL
Kleiweg 500
Rotterdam 3045 PM
NL
Listed location countries
Age
Inclusion criteria
- Confirmed asthma diagnosis according to the asthma guidelines.
- Diagnosed with severe, refractory asthma with eligibility for treatment with
specific asthma biologics (omalizumab, mepolizumab, benralizumab, reslizumab,
dupilumab, tezepelumab) as determined at the regional asthma Multi-Disciplinary
Team Meeting (MDTM) according to the asthma guidelines.
- Age >= 18 years.
- Previous prescribed asthma biologics have to be ceased >= 4 times the
half-life of that specific biologic.
- The patient has be relatively stable. The onset of an asthma exacerbation
and/or a lower respiratory tract infection which requires a treatment with
prednisolone and/or antibiotics has to be >= 2 weeks ago.
Exclusion criteria
- Primary COPD diagnosis
- History of cancer:
> Current basal cell carcinoma of the skin, localized squamous cell carcinoma
of the skin or in situ carcinoma of the cervix. Patients are eligible to
participate in the study provided that curative therapy was completed at least
12 months prior to the start of the study.
> Current other malignancies. Patients are eligible to participate in the study
provided that curative therapy was completed at least 5 years prior to the
start of the study.
- The patient must be stable. The onset of an asthma exacerbation and/or a
respiratory infection has to be >= 4 weeks ago.
- Inability to fully understand and read the Dutch language.
- Being unable to engage in a remote monitoring and coaching program through
the use of a smartphone.
- Being unable to engage in physical activity (e.g. physical disability).
- Current pregnancy.
- Current breastfeeding.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-006681-21-NL |
| CCMO | NL79996.100.22 |