Phase
Condition
Asthma
Lung Disease
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age between 18 and 75 years at the time of inclusion
Asthma diagnosed for at least one year including a history of
FEV1 and/or FVC reversibility of more than 12% and than 200 ml documented inthe patient's record
OR FEV1 variability of more than 20% between two visits
OR positive methacholine test
- Severe uncontrolled asthma monitored for at least six months in the investigationcenter with at least two assessments:
high-dose of inhaled corticosteroids (ICS >1,000 μg/day of beclometasoneequivalent) in combination with another controller at a stable dosage for atleast three months
ACQ-5 score >1.5 and/or more than two severe exacerbations (i.e exacerbationrequiring ≥ 3 days of systemic corticosteroids, hospitalization or admission atthe emergency department) in the past year
Blood eosinohils ≥300/mm3 within the 12 past months
Decision to introduce mepolizumab according to regulatory approval
Patient agreement to receive Mepolizumab
Body mass index (BMI) within the range [18.5 - 35] kg/m2.
Able to give signed informed consent which includes compliance with the requirementsand restrictions listed in the informed consent form (ICF) and in this protocol
Exclusion
Exclusion Criteria:
Body Mass Index <18.5 or >35 kg/m2
Active smoker or active smoking during the last 6 months or cumulative > 10pack-years
All conditions responsible for physical disability (neurological, orthopedic,psychiatric, non-exhaustive list) or other condition limiting exercise in theinvestigator's opinion
Any chronic respiratory or cardiac pathology which may interfere with the assessmentof asthma according to the investigator's opinion
Prior treatment with mepolizumab or benralizumab
Bronchial thermoplasty during the past 12 months
Contraindication to mepolizumab
Non-coverage by the social security insurance
Pregnant, breastfeeding, or lactating women
Patient unable to receive information
Refusal to sign the consent form
Unwillingness or inability to follow the study procedures, in the opinion of theinvestigator
Person deprived of the liberty Person benefiting from a system of legal protection (guardianship...)
Study Design
Connect with a study center
Lille University Hospital
Lille,
FranceActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.