Status:
RECRUITING
Mepolizumab and Physical Activity in Severe Asthma
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Asthma
Asthma; Eosinophilic
Eligibility:
All Genders
18-75 years
Brief Summary
Severe asthma is a debilitating condition associated with frequent symptoms, life-threatening exacerbations and corticosteroid side-effects. Exercise limitation due to exercise-induced bronchoconstric...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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…)
Key Trial Info
Start Date :
February 2 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 2 2025
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT05404763
Start Date
February 2 2023
End Date
July 2 2025
Last Update
May 23 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lille University Hospital
Lille, France