Clinical trial NCT05626777: Symptoms Control and adhErenCe Assessment During Treatment With MepolizUmab New pREfilled Devices
Official title: Symptoms Control and adhErenCe Assessment During Treatment With MepolizUmab New pREfilled Devices
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Asthma
Keywords: Pulmonary Medicine
severe asthma
uncontrolled
mepolizumab
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2022-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Patient aged ≥ 18 years
2. Severe asthma diagnosed by a pulmonologist and followed for at least a year
3. Blood eosinophilia ≥ 0.15 G / L in the 12 months preceding inclusion in the trial.
4. At least 2 exacerbations in the past 12 months, each time treated with oral corticosteroid therapy or an increase in dosage of oral corticosteroid therapy prescribed for a long time, for at least 72 hours.
5. High dose inhaled corticosteroid therapy (\> 800 μg / d budesonide,\> 500 μg / d fluticasone,\> 1000 μg / d beclometasone, etc.) and at least one second controller asthma treatment with Long-Acting Beta-Agonists or Long-Acting Muscarinic Antagonists
6. Patient must have an efficient contraception method
7. Patient affiliated to a social security scheme.
8. Patient able to give free, informed and written consent.

Exclusion Criteria:

1. Pregnant woman (urinary beta-HCG positive at inclusion) or breastfeeding
2. Active smoking or ex-smoking for less than 6 months and more than 10 pack-years
3. Exacerbation in the 4 weeks preceding first Mepolizumab injection
4. Patient who has already been treated with Mepolizumab or another anti-IL-5 or -5R treatment
5. Patient currently using a biotherapy indicated in severe asthma other than anti-IL5 or 5R treatments or stopped for less than 2 months
6. Treatment underway with another biotherapy not indicated for severe asthma
7. Patient participating in other interventional research, excluding routine care research (old regulation) and category 2 research not interfering with primary endpoint analysis
8. Other chronic respiratory pathology (bronchiectasis, chronic obstructive pulmonary disease, pulmonary fibrosis, etc.)
9. Any other uncontrolled chronic pathology, the presence of which would be considered incompatible with the performance of the study by the investigator
10. Patient under guardianship, curatorship or legal protection

Primary outcomes:
measure: Compare asthma control after 6 months of treatment between: A1 Group of patients using a pre-filled syringe administered monthly by a nurse, using a pre-filled syringe B1 Group of patients receiving self-administered monthly, using an auto-injector pen
timeFrame: MONTHS 6
Secondary outcomes:
measure: Compare asthma control a. between groups A2 and B2 (see study design §4 below for groups description) b. between groups A1 and A2 c. between groups B1 and B2
timeFrame: MONTHS 12
measure: Compare Mean change in Asthma Control Test (ACT) score in each group
timeFrame: months 12
measure: Compare the proportion of patients with an ACT score change of at least 4 points in each group
timeFrame: months 12
measure: Compare the number of exacerbation of asthma after 6 and 12 months of treatment (between A and B)
timeFrame: months 12
measure: Compare the number of exacerbation of asthma requiring a visit to the emergency service or hospitalization after 6 and 12 months of treatment (between A and B)
timeFrame: months 12
measure: Compare the change of exacerbation of asthma before and during the 12 months of treatment between A et B
timeFrame: months 12
measure: Compare the proportion of patients requiring unscheduled medical consultation for asthma, after 12 months of treatment between A et B
timeFrame: months 12
measure: Compare oral corticosteroids consumption before and after Mepolizumab between group A and B
timeFrame: months 12
measure: Compare treatment compliance between groups A and B
timeFrame: months 12
measure: Compare bronchial inflammation by measurement of Fraction of exhaled Nitric Oxide (FeNO) after 6 and 12 months of treatment (between groups A and B)
timeFrame: months 12
measure: Compare blood eosinophilia evolution after 6 and 12 months of treatment in each grouporal corticosteroids consumption before and after Mepolizumab between group A and B
timeFrame: Months 0, 3, 6, 9, 12
measure: Compare respiratory function measurement after 6 and 12 months of treatment (between A and B)
timeFrame: months 1, 6 12
measure: Compare the safety of treatment with Mepolizumab
timeFrame: Months 12
measure: Compare the patients' quality of life in each group
timeFrame: months 1, 6 12
measure: Compare the patients' quality of life in each group
timeFrame: months 1, 6 12
measure: Compare the patient satisfaction regarding asthma treatment in each group
timeFrame: months 1, 6 12
measure: dyspnea
timeFrame: months 1, 6 12
Other outcomes:
Locations:
city: Besançon
country: France
facility: Service de Pneumologie CHU Besançon
city: Dijon
country: France
facility: Service de Pneumologie CHU Dijon
city: Lille
country: France
facility: Service de Pneumologie et ImmunoAllergologie CHU Lille
city: Lyon
country: France
facility: Departement of Pulmonology, Croix-Rousse Hospital, Hospices Civils de Lyon
city: Montpellier
country: France
facility: Service des Maladies Respiratoires CHU Montpellier
city: Paris
country: France
facility: Service de Pneumologie A APHP Bichat
city: Reims
country: France
facility: Service des Maladies Respiratoires CHU Reims
city: Toulouse
country: France
facility: Service de Pneumologie CHU Toulouse
Study officials:
affiliation: Departement of Pulmonology, Croix-Rousse Hospital, Hospices Civils de Lyon
name: Gilles Devouassoux, Pr
role: PRINCIPAL_INVESTIGATOR
References: