Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Hospital, Lille
With
GlaxoSmithKline
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age between 18 and 75 years at the time of inclusion
Asthma diagnosed for at least one year including a history of
1. FEV1 and/or FVC reversibility of more than 12% and than 200 ml documented in the patient's record
2. OR FEV1 variability of more than 20% between two visits
3. OR positive methacholine test
Severe uncontrolled asthma monitored for at least six months in the investigation center with at least two assessments:
1. high-dose of inhaled corticosteroids (ICS \>1,000 μg/day of beclometasone equivalent) in combination with another controller at a stable dosage for at least three months
2. ACQ-5 score \>1.5 and/or more than two severe exacerbations (i.e exacerbation requiring ≥ 3 days of systemic corticosteroids, hospitalization or admission at the emergency department) in the past year
3. Blood eosinohils ≥300/mm3 within the 12 past months
4. Decision to introduce mepolizumab according to regulatory approval
5. 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 requirements and restrictions listed in the informed consent form (ICF) and in this protocol
You may not be if
Body Mass Index \<18.5 or \>35 kg/m2
Active smoker or active smoking during the last 6 months or cumulative \> 10 pack-years
All conditions responsible for physical disability (neurological, orthopedic, psychiatric, non-exhaustive list) or other condition limiting exercise in the investigator's opinion
Any chronic respiratory or cardiac pathology which may interfere with the assessment of 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 the investigator
Person deprived of the liberty Person benefiting from a system of legal protection (guardianship…)
Clareo Health | Mepolizumab and Physical Activity in Severe Asthma
