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Symptoms control and adhErenCe assessment during treatment with mepolizUmab new pREfilled devices. SECURE

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501029-19-00
Acronym
69HCL21_0419
Enrollment
130
Registered
2022-10-03
Start date
2022-12-13
Completion date
2025-03-27
Last updated
2024-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

Composite endpoint: Treatment compliance using Pharmacy accountability of study treatment and monthly patient diary after 6 months of treatment with Mepolizumab. Patient will be considered as compliant if all treatment doses of period have been used. Proportion of compliant patients will be compared between groups of patients. Proportion of patients with controlled asthma using the ACT score, after a period of 6 months of treatment with Mepolizumab will be compared between groups of patients.

Detailed description

Proportion of patients with asthma control assessed by the ACT score between: group receiving Mepolizumab self-administered, using PFS and group receiving M. self-administered using an AI from 6 months to 12 months (between groups A2 and B2); M. administered by a PFS by a nurse for first 6 months & self-administered by a PFS for the following 6 months between groups A1 and A2; M. self-administered by an AI during first 6 months &self-administered by an AI the 6 months between groups B1 and B2, 2. 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, 3. 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, 4. Comparison of the proportion of patients with an exacerbation of asthma during the 12 months of treatment (between groups A and B), 5. 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), 6. 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, 7. The proportion of patients requiring unscheduled medical consultation for asthma during the 12 months of treatment (between groups A and B), 8. Cumulative dose of oral corticosteroids before and after 12 months of treatment with Mepolizumab (exacerbation treatment excluded) between group A and B, 9. 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., 10. Carrying out a FeNO at V1, V2 and V3 after 6 and 12 months of Mepolizumab treatment between groups A and B, 11. Performing a hemogram on peripheral blood to measure eosinophilia evolution at M0, M3, M6, M9 and M12, 12. FEV1 measurement, % of theoretical FEV1 value, FEV1 / FVC at V1, V2 and V3, 13. Collection of adverse events related to the study treatment, according to grade 1 to 5., 14. Calculation of the mini-AQLQ quality of life score and SNOT-22 score at V1, V2 and V3, 15. Patient satisfaction questionnaire SATQ-F at V1, V2 and V3 and assessment of the preferences of patients in each group with respect to the Mepolizumab administration system at V1, V2 and V3, 15.16. Calculation of mMRC score for dyspnea at V1, V2 and V3 visits

Interventions

DRUG5 microgrammes/dose
DRUGsolution à inhaler
DRUGEnerzair Breezhaler 114 micrograms/46 micrograms/136 micrograms inhalation powder
DRUGInnovair NEXThaler 200 microgrammes/6 microgrammes par dose
DRUGpoudre pour inhalation.
DRUGRelvar Ellipta 92 micrograms/22 micrograms inhalation powder
DRUGRevinty Ellipta 92 micrograms/22 micrograms inhalation powder
DRUGPROPIONATE DE FLUTICASONE/SALMETEROL VIATRIS 500 microgrammes/50 microgrammes/dose
DRUGpoudre pour inhalation en récipient unidose
DRUGTIOTROPIUM VIATRIS 18 microgrammes
DRUGpoudre pour inhalation en gélule
DRUGSPIRIVA 18 microgrammes poudre pour inhalation en gélule
DRUGSERETIDE DISKUS 500 microgrammes/50 microgrammes/dose
DRUGSymbicort Turbuhaler 400/12
DRUG400 microgram / 12 microgram per dosis
DRUGinhalatiepoeder
DRUGPROPIONATE DE FLUTICASONE/SALMETEROL BIOGARAN AIRMASTER 500 microgrammes/ 50 microgrammes/dose
DRUGFormodual NEXThaler 200 microgrammes/6 microgrammes par inhalation
DRUGDuoResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder

Sponsors

Hospices Civils De Lyon
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Composite endpoint: Treatment compliance using Pharmacy accountability of study treatment and monthly patient diary after 6 months of treatment with Mepolizumab. Patient will be considered as compliant if all treatment doses of period have been used. Proportion of compliant patients will be compared between groups of patients. Proportion of patients with controlled asthma using the ACT score, after a period of 6 months of treatment with Mepolizumab will be compared between groups of patients.

Secondary

MeasureTime frame
Proportion of patients with asthma control assessed by the ACT score between: group receiving Mepolizumab self-administered, using PFS and group receiving M. self-administered using an AI from 6 months to 12 months (between groups A2 and B2); M. administered by a PFS by a nurse for first 6 months & self-administered by a PFS for the following 6 months between groups A1 and A2; M. self-administered by an AI during first 6 months &self-administered by an AI the 6 months between groups B1 and B2, 2. 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, 3. 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, 4. Comparison of the proportion of patients with an exacerbation of asthma during the 12 months of treatment (between groups A and B), 5. Comparison of the proportion of patients with an exacerbatio

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026