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

Phase 1

• Conditions: Asthma; MedDRA version: 20.0Level: PTClassification code: 10003553Term: Asthma Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2022-501029-19-00
• Lead Sponsor: Hospices Civils De Lyon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-24
• Study Completion: 2024-07-03
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Patient aged = 18 years, Severe asthma diagnosed by a pulmonologist and followed for at least a year, Blood eosinophilia = 0.15 G / L in the 12 months preceding inclusion in the trial., 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, 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 LABA or LAMA, Patient affiliated to a social security scheme, Patient able to give free, informed and written consent., Patient must have an efficient contraception method

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified