NCT05404763Active, not recruiting
Mepolizumab and Physical Activity in Severe Asthma
Evolution of Physical Activity in Severe Asthmatic Patients Treated With Mepolizumab
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 62 (actual)
- First submitted
- 21 Mar 2022
- Start date
- Feb 2023
- Primary completion date
- Aug 2026
- Lead sponsor
- University Hospital, Lille
- Diseases
- Asthma
- NCT number
- NCT05404763
What you commit to
- Study type: Observational
- Participants enrolled: 62
- From Feb 2023 to the primary completion date, Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with mepolizumab or benralizumab
Other illness
- 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
Other
- Body Mass Index \<18.5 or \>35 kg/m2
- Active smoker or active smoking during the last 6 months or cumulative \> 10 pack-years
- 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…)
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lille University Hospital Coordinator of this site? Confirm its status | Lille | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.