AsthmaTEXASNCT05404763
Mepolizumab and Physical Activity in Severe Asthma
An observational study of Asthma and Asthma; Eosinophilic, run by University Hospital, Lille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma, Asthma; Eosinophilic
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2023to 2 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: uncontrolled eosinophilic severe asthma with indication for treatment with mepolizumab
Who may be able to join
- 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:
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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…)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Asthma, Asthma; Eosinophilic
- Keywords
- Severe asthma,, Physical activity, Exercise, Dyspnea
- Medical subject headings
- Asthma, Pulmonary Eosinophilia, Motor Activity, Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of daily steps
Measured: after 6 months of treatment with mepolizumab
Secondary outcomes (17)
Time with moderate physical activity (between 3 and 6 METs) and intense activity (>6 METs)
Measured: Baseline, at 3 months and at 6 months
Percentage of time spent with moderate physical activity (between 3 and 6 METs) and intense activity (>6 METs)
Measured: Baseline, at 3 months and at 6 months
Ricci and Gagnon questionnaire score •
Ricci and Gagnon questionnaire is Score of physical activity , 9 items, total range score from 6 to 45, higher score indicating a higher level of physical activity
Measured: Baseline, at 3 months and at 6 months
Endurance time during a sub-maximal exercise (80% of maximum load)
Measured: Baseline, at 3 months and at 6 months
Baseline Dyspnea Index (BDI)
The BDI is an interviewer-administered rating of severity of dyspnea at a single state. It provides a multidimensional measurement of dyspnea based on 3 components It comprises 3 domains (functional impairement, magnitude of task and magnitude of effort) scoring from 0 (very severe) to 4 (no impairment) with a recall of the last two weeks. The total score ranges from 0 to 12, the lower the score, the worse the severity of dyspnea.
Measured: Baseline, at 3 months and at 6 months
Transition Dyspnea Index (TDI) scores
The TDI measures changes in each domain of dyspnea severity from the baseline as established by the BDI. The change is rated by seven grades ranging from -3 (major deterioration) to +3 (major improvement). The total score ranges from - 9 to + 9
Measured: Baseline, at 3 months and at 6 months
The modified Medical Research Council (mMRC) scale
The mMRC scale is a self-assessed unidimensional scale rating the impact of dyspnea on physical activity in everyday life. The patient chooses the answer that best describes his level of limitation related to dyspnea among 5 proposals. The score is between 0 (absence of dyspnea) to 4 (permanent dyspnea). The MCID considered is 1 unit although data are limited.
Measured: Baseline, at 3 months and at 6 months
Multidimensional Dyspnea Profile (MDP) scores
The MDP questionnaire is an 11-item hetero-questionnaire evaluating both sensory and affective dimensions of dyspnea, respectively the sensation produced by the respiratory stimulus and the emotion associated with this sensation.
Measured: Baseline, at 3 months and at 6 months
ACQ-5 score
The ACQ-5 is a shortened version of the ACQ that assesses asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) omitting the forced expiratory volume in 1 second measurement and short acting beta antagonist use from the original ACQ score. Patients are asked to recall how their asthma has been during the previous week by responding to 5 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-5 score is the mean of the responses. Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and <1.5 indicate partly controlled asthma, and a score ≥1.5 indicates not well controlled asthma . Individual changes of at least 0.5 are considered to be clinically meaningful.
Measured: Baseline, at 3 months and at 6 months
AQLQ score
The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item, 4-domain instrument that can either be self- or interviewer-administered. The recall-time is two weeks. The four domains covered are: (i) symptoms (11 items), (ii) activity limitation (12 items, 5 of which are individualized), (iii) emotional function (5 items), and (iv) environmental exposure (4 items). Each item is ranked by the patient using a 7-point Likert scale ranging from 1 (severely impaired) to 7 (not impaired at all). Scores range from 1 to 7, higher scores indicate better quality of life and a minimally important difference (for overall scores and for each sub-domain) has been established at 0.5.
Measured: Baseline, at 3 months and at 6 months
Hospital Anxiety and Depression scores (HADS)
Depressive symptoms will be assessed using The Hospital Depression and Anxiety Scale.The scale allows to detect anxiety and depression using 14 items rated from 0-3.
Measured: Baseline, at 3 months and at 6 months
Respiratory capacity by Spirometry
Measured: Baseline, at 3 months and at 6 months
Respiratory capacity by plethysmography
Measured: Baseline, at 3 months and at 6 months
Forced inspiratory by Spirometry
Measured: Baseline, at 3 months and at 6 months
Ventilatory function by Spirometry
Measured: Baseline, at 3 months and at 6 months
Forced oscillation by impulse oscillometry (the Tremoflo ® oscillometry system)
Measured: Baseline, at 3 months and at 6 months
Frequency of serious and non-serious side effects
Measured: Baseline, at 3 months and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start2 Feb 2023
- Primary completion2 Aug 2026 (estimated)
- Study completion2 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Cécile Chenivesse, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404763
- Sponsor's protocol ID
- 2020_56
- Other IDs
- 2021-A03205-36
- Acronym
- TEXAS
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Physical Activity in Severe Asthmatic Patients Treated With Mepolizumab
- ClinicalTrials.gov ID
- NCT05404763
- Acronym / sponsor ID
- TEXAS / 2020_56
- Conditions
- Asthma, Asthma; Eosinophilic
- Keywords
- Severe asthma,, Physical activity, Exercise, Dyspnea
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 2 Aug 2026 (estimated)
- Study completion
- 2 Aug 2026 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- uncontrolled eosinophilic severe asthma with indication for treatment with mepolizumab
Key inclusion criteria (13 listed)
- Age between 18 and 75 years at the time of inclusion
- Asthma diagnosed for at least one year including a history of
- Severe uncontrolled asthma monitored for at least six months in the investigation center with at least two assessments:
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of daily steps
Time frame: after 6 months of treatment with mepolizumab
17 secondary outcomes
Time with moderate physical activity (between 3 and 6 METs) and intense activity (>6 METs)
Time frame: Baseline, at 3 months and at 6 months
Percentage of time spent with moderate physical activity (between 3 and 6 METs) and intense activity (>6 METs)
Time frame: Baseline, at 3 months and at 6 months
Ricci and Gagnon questionnaire score •
Time frame: Baseline, at 3 months and at 6 months
Endurance time during a sub-maximal exercise (80% of maximum load)
Time frame: Baseline, at 3 months and at 6 months
Baseline Dyspnea Index (BDI)
Time frame: Baseline, at 3 months and at 6 months
Transition Dyspnea Index (TDI) scores
Time frame: Baseline, at 3 months and at 6 months
The modified Medical Research Council (mMRC) scale
Time frame: Baseline, at 3 months and at 6 months
Multidimensional Dyspnea Profile (MDP) scores
Time frame: Baseline, at 3 months and at 6 months
ACQ-5 score
Time frame: Baseline, at 3 months and at 6 months
AQLQ score
Time frame: Baseline, at 3 months and at 6 months
Hospital Anxiety and Depression scores (HADS)
Time frame: Baseline, at 3 months and at 6 months
Respiratory capacity by Spirometry
Time frame: Baseline, at 3 months and at 6 months
Respiratory capacity by plethysmography
Time frame: Baseline, at 3 months and at 6 months
Forced inspiratory by Spirometry
Time frame: Baseline, at 3 months and at 6 months
Ventilatory function by Spirometry
Time frame: Baseline, at 3 months and at 6 months
Forced oscillation by impulse oscillometry (the Tremoflo ® oscillometry system)
Time frame: Baseline, at 3 months and at 6 months
Frequency of serious and non-serious side effects
Time frame: Baseline, at 3 months and at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile Chenivesse, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Asthma; Eosinophilic, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of daily steps (time frame: after 6 months of treatment with mepolizumab). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.