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Active, Not Recruiting

NCT Number: NCT05404763

Mepolizumab and Physical Activity in Severe Asthma

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Asthma Asthma; Eosinophilic Behavior Bronchial Diseases Dyspnea Eosinophilia Hematologic Diseases Hemic and Lymphatic Diseases Hypereosinophilic Syndrome Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders Lung Diseases Lung Diseases, Obstructive Motor Activity Pathological Conditions, Signs and Symptoms Pulmonary Eosinophilia Respiration Disorders Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lille University Hospital

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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…)

Treatment and study plan

Primary outcomes

  1. Number of daily steps

    Time frame: after 6 months of treatment with mepolizumab

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Endurance time during a sub-maximal exercise (80% of maximum load)

    Time frame: Baseline, at 3 months and at 6 months

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Respiratory capacity by Spirometry

    Time frame: Baseline, at 3 months and at 6 months

  13. Respiratory capacity by plethysmography

    Time frame: Baseline, at 3 months and at 6 months

  14. Forced inspiratory by Spirometry

    Time frame: Baseline, at 3 months and at 6 months

  15. Ventilatory function by Spirometry

    Time frame: Baseline, at 3 months and at 6 months

  16. Forced oscillation by impulse oscillometry (the Tremoflo ® oscillometry system)

    Time frame: Baseline, at 3 months and at 6 months

  17. Frequency of serious and non-serious side effects

    Time frame: Baseline, at 3 months and at 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Evolution of Physical Activity in Severe Asthmatic Patients Treated With Mepolizumab

Acronym: TEXAS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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