Impact of Mepolizumab on Physical Activity in Severe Asthma
Evolution of Physical Activity in Severe Asthmatic Patients Treated With Mepolizumab
This study is testing if a medication called mepolizumab can help people with severe asthma be more active and improve their ability to exercise over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 102 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Drugs / interventions | mepolizumab, benralizumab |
| Locations | 1 site (Lille) |
| Trial ID | NCT05404763 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of mepolizumab, a monoclonal antibody targeting interleukin-5, on physical activity and exercise tolerance in patients with severe eosinophilic asthma. It aims to determine whether a 6-month treatment with mepolizumab can improve daily physical activity levels and enhance ventilatory mechanics. The study will include patients aged 18 to 75 who have been diagnosed with severe asthma and have a history of exacerbations and high eosinophil counts. The findings could provide insights into the relationship between asthma management and physical activity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with severe uncontrolled asthma and a documented history of exacerbations.
Not a fit: Patients with mild asthma or those not meeting the criteria for severe uncontrolled asthma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved physical activity and quality of life for patients with severe asthma.
How similar studies have performed: While studies have explored the effects of mepolizumab on asthma symptoms, the specific focus on physical activity and exercise tolerance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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...)
Where this trial is running
Lille
- Lille University Hospital — Lille, France (Recruiting)
Study contacts
- Principal investigator: Cécile Chenivesse, MD,PhD — University Hospital, Lille
- Study coordinator: Cécile Chenivesse, MD,PhD
- Email: cecile.chenivesse@chru-lille.fr
- Phone: 0320445962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.