Mepolizumab and Physical Activity in Severe Asthma (TEXAS)

April 21, 2026 updated by: University Hospital, Lille

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Lille, France
        • Lille University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

uncontrolled eosinophilic severe asthma with indication for treatment with mepolizumab

Description

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…)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of daily steps
Time Frame: after 6 months of treatment with mepolizumab
after 6 months of treatment with mepolizumab

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Baseline, at 3 months and at 6 months
Ricci and Gagnon questionnaire score •
Time Frame: Baseline, at 3 months and at 6 months
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
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, at 3 months and at 6 months
Baseline Dyspnea Index (BDI)
Time Frame: Baseline, at 3 months and at 6 months
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.
Baseline, at 3 months and at 6 months
Transition Dyspnea Index (TDI) scores
Time Frame: Baseline, at 3 months and at 6 months
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
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
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.
Baseline, at 3 months and at 6 months
Multidimensional Dyspnea Profile (MDP) scores
Time Frame: Baseline, at 3 months and at 6 months
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.
Baseline, at 3 months and at 6 months
ACQ-5 score
Time Frame: Baseline, at 3 months and at 6 months
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.
Baseline, at 3 months and at 6 months
AQLQ score
Time Frame: Baseline, at 3 months and at 6 months
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.
Baseline, at 3 months and at 6 months
Hospital Anxiety and Depression scores (HADS)
Time Frame: Baseline, at 3 months and at 6 months
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.
Baseline, at 3 months and at 6 months
Respiratory capacity by Spirometry
Time Frame: Baseline, at 3 months and at 6 months
Baseline, at 3 months and at 6 months
Respiratory capacity by plethysmography
Time Frame: Baseline, at 3 months and at 6 months
Baseline, at 3 months and at 6 months
Forced inspiratory by Spirometry
Time Frame: Baseline, at 3 months and at 6 months
Baseline, at 3 months and at 6 months
Ventilatory function by Spirometry
Time Frame: Baseline, at 3 months and at 6 months
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
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
Baseline, at 3 months and at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cécile Chenivesse, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 2, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020_56
  • 2021-A03205-36 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings