Evolution of Physical Activity in Severe Asthmatic Patients Treated With Mepolizumab
Severe asthma is a debilitating condition associated with frequent symptoms, life-threatening exacerbations and corticosteroid side-effects. Exercise limitation due to exercise-induced bronchoconstriction, dynamic lung hyperinflation and comorbidity may be a strong determinant of the disease burden. Mepolizumab is a monoclonal anti-interleukin-5 (IL-5) antibody that reduces the rate of severe exacerbations, asthma symptoms and oral glucocorticoid requirement, and improves quality of life and work productivity in severe eosinophilic asthma. However, its impact on physical activity and exercise tolerance is unknown. We hypothesize that a 6-month treatment with mepolizumab is associated with an improvement in daily life physical activity and exercise tolerance in relation with enhanced ventilatory mechanics.
• 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 in the 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 investigation center with at least two assessments:
‣ 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
⁃ 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
⁃ 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 requirements and restrictions listed in the informed consent form (ICF) and in this protocol