A Phase 4 interventional study of Pre-filled syringe, mepolizumab 100 mg/month and Auto-injector pen, mepolizumab 100 mg/month in Asthma, sponsored by Hospices Civils de Lyon. Active, not recruiting at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Hospices Civils de Lyon · Phase 4, Interventional, and Treatment
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.
4,012 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's enrollment of 20 is below the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →Hospices Civils de Lyon is the lead sponsor of 1,856 studies on the registry; 442 are open to participants now.
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Exclusion Criteria:
Pre-filled syringe, mepolizumab, 100 mg/month, 6 first months of treatment administered by nurse, 6 last months of treatment administered by patient
Drug: Pre-filled syringe, mepolizumab 100 mg/month
Auto-injector pen, mepolizumab, 100 mg/month 12 months of treatment administered by patient
Drug: Auto-injector pen, mepolizumab 100 mg/month
Pre-filled syringe, mepolizumab, 100 mg/month, 6 first months of treatment administered by nurse, 6 last months of treatment administered by patient
Auto-injector pen, mepolizumab, 100 mg/month 12 months of treatment administered by patient
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
Proportion of patients with controlled asthma using the ACT score (asthma control test), after a period of 6 months of treatment with Mepolizumab will be compared between groups of patients. The ACT score is a single score varying from 5 to 25 points. Asthma is considered to be controlled when the ACT score is ≥ 20. In the study, asthma will be considered controlled if the ACT score is ≥ 20 or better controlled if it increases by at least 4 points during the treatment period.
Time frame: MONTHS 6
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
Proportion of patients with asthma control assessed by the ACT score between: 1. The group of patients receiving Mepolizumab self-administered monthly, using PFS and the group of patients receiving Mepolizumab self-administered monthly using an AI from 6 months to 12 months (between groups A2 and B2) 2. Mepolizumab administered by a PFS by a nurse for the first 6 months and self-administered by a PFS for the following 6 months in the same group of patients (between groups A1 and A2) 3. Mepolizumab self-administered by an AI during the first 6 months and self-administered by an AI the following 6 months in the same group of patients (between groups B1 and B2).
Time frame: MONTHS 12
Compare Mean change in Asthma Control Test (ACT) score in each group
Comparison of the mean change in ACT score from baseline between groups: A1 vs B1, A2 vs B2, A1 vs A2, B1 vs B2, and A vs B
Time frame: months 12
Compare the proportion of patients with an ACT score change of at least 4 points in each group
Comparison of the proportion of patients with a change in ACT score of at least 4 points from baseline between groups: A1 vs B1, A2 vs B2, A1 vs A2, B1 vs B2, and A vs B
Time frame: months 12
Compare the number of exacerbation of asthma after 6 and 12 months of treatment (between A and B)
Comparison of the proportion of patients with an exacerbation of asthma during the 12 months of treatment (between groups A and B)
Time frame: months 12
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)
Comparison of the proportion of patients with an exacerbation of asthma requiring an emergency service visit or hospitalization during the 12 months of treatment (between groups A and B)
Time frame: months 12
Compare the change of exacerbation of asthma before and during the 12 months of treatment between A et B
Comparison of the proportion of patients with an exacerbation of asthma during the 12 months of treatment with Mepolizumab versus the proportion of patients with an exacerbation of asthma during the 12 months prior to treatment with Mepolizumab
Time frame: months 12
Compare the proportion of patients requiring unscheduled medical consultation for asthma, after 12 months of treatment between A et B
The proportion of patients requiring unscheduled medical consultation for asthma during the 12 months of treatment (between groups A and B)
Time frame: months 12
Compare oral corticosteroids consumption before and after Mepolizumab between group A and B
Cumulative dose of oral corticosteroids before and after 12 months of treatment with Mepolizumab (exacerbation treatment excluded) between group A and B
Time frame: months 12
Compare treatment compliance between groups A and B
Treatment compliance using the MARS-5 questionnaire administered after 6 and 12 months of treatment with Mepolizumab. The MARS-5 score will be compared between both groups of patients.
Time frame: months 12
Compare bronchial inflammation by measurement of Fraction of exhaled Nitric Oxide (FeNO) after 6 and 12 months of treatment (between groups A and B)
Carrying out a FeNO at V1, V2 and V3 after 6 and 12 months of Mepolizumab treatment between groups A and B
Time frame: months 12
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
Performing a hemogram on peripheral blood to measure eosinophilia evolution at M0, M3, M6, M9 and M12
Time frame: Months 0, 3, 6, 9, 12
Compare respiratory function measurement after 6 and 12 months of treatment (between A and B)
First measurement : Forced Exhaled Volume 1 (FEV1) Second measurement : Forced Vital Capacity (FVC) These two measurements are volumes which will be aggregated in order to obtain one final outcome measurement : FEV1/FVC in %
Time frame: months 1, 6 12
Compare the safety of treatment with Mepolizumab
Collection of adverse events related to the study treatment throughout the study
Time frame: Months 12
Compare the patients' quality of life in each group
Calculation of the mini-AQLQ quality of life score at V1, V2 and V3
Time frame: months 1, 6 12
Compare the patients' quality of life in each group
Calculation of the SNOT-22 score at V1, V2 and V3
Time frame: months 1, 6 12
Compare the patient satisfaction regarding asthma treatment in each group
Patient satisfaction questionnaire SATQ-F at Visit 1, Visit 2 and Visit 3 and assessment of the preferences of patients in each group with respect to the Mepolizumab administration system at Visit 1, Visit 2 and Visit 3
Time frame: months 1, 6 12
dyspnea
Calculation of mMRC score at Visit 1, Visit 2 and Visit 3
Time frame: months 1, 6 12
Started Mar 2023 (actual). Primary completion is estimated for Mar 2026, 36 months after the start.
Of 76 non-industry phase 4 interventional studies under Asthma, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 36 months is above that.
Counting every sponsor, half of 135 studies reached it within 22 months; a quarter within 11 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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