Symptoms Control and adhErenCe Assessment During Treatment With MepolizUmab New pREfilled Devices
Status:
Not yet recruiting
Trial end date:
2025-11-01
Target enrollment:
Participant gender:
Summary
Asthma is a common pathology, with a prevalence of 6 to 8% and more than 4 million patients
in France. Its management is based on different therapeutic axes. Their use is very dependent
on disease control, with therapeutic escalation, from treatment on demand to a combination of
them at high dosage, according to the severe asthma's phenotype.
Despite these effective therapeutic tools, there is a lack of control of the disease in the
vast majority of cases, affecting at least 60% of asthmatics. Among the factors associated
with lack of control, non-compliance with inhaled therapies is frequent and requires to be
systematically assessed in the absence of control.
Its evaluation by definition is complex and variously appreciated, fluctuating from 40 to
80%. The means proposed for evaluating it involve doctor/patient interviews, evaluation of
the therapeutic response, questionnaires, evaluation of drug consumption (evaluation of
number of empty boxes, integrated electronic device, withdrawal of drugs from pharmacies,
etc).
Asthma control is commonly evaluated using the validated Asthma Control Test score, in
clinical practice and/or in research fields. An ACT score greater than 20 indicates
well-controlled asthma. In addition, a change of at least 3 points is likely to indicate a
clinically meaningful change in asthma control (Minimally Clinical Important Difference) in
an individual patient over time and a change of 4 points or more further reduces the risk
that the change is due to measurement error.
In the context of severe eosinophilic asthma, Mepolizumab has shown its benefit in
controlling asthma, reducing the number of exacerbations and its ability to decrease the use
of oral corticosteroids (MENSA, SIRIUS).
Mepolizumab is now available in 2 new "ready-to-use" forms: a pre-filled syringe and an
auto-injector pen. Both systems can be administered at home either by a nurse or by the
patient himself (self-administration). The choice is left to the discretion of the
prescribing pulmonologist.
These new possibilities of Mepolizumab administration offer greater freedom to the patient,
possibly allowing him to empower himself by carrying out his own treatment, without
constraint and without being dependent on the availability of a nurse or another healthcare
professional qualified to inject Mepolizumab.
These new methods of Mepolizumab self- administration also open the field to therapeutic
non-compliance, a new problem in the field of biotherapies used for the treatment of severe
asthma.
The investigator hypothesize a potential therapeutic non-compliance associated with the new
method of administration of Mepolizumab, with self-injection by the patient, without the
assistance of a nurse.
To assess this problem, the investigator propose to compare in a therapeutic trial
Mepolizumab administered by pre-filled syringe by a home nurse every month versus Mepolizumab
self-administered by auto-injector pen by the patient every month.