Clinical trial · Observational
Airway Remodeling During Mepolizumab Treatment
Airway Remodeling Changes Induced by Mepolizumab in Severe Eosinophil Asthma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Chronic airway changes, such as smooth muscle hypertrophy/hyperplasia, reticular basement membrane (RBM) thickening, goblet cells hyperplasia characterize severe asthma. Chronic inflammation, and especially eosinophilia and T2 cytokines are involved in these structural changes. The aim of this prospective observational study is to assess airway changes, assessed by bronchial biopsies before treatment, then after 6 months and 12 months, induced by mepolizumab in 40 severe asthma patients who will receive the treatment as part of their standard care. Changes in RBM thickening, in airway smooth muscle (ASM) area, in the number of PGP9 sections will be assessed on bronchial biopsies after 6 months and 12 months of mepolizumab treatment. Bronchoalveolar lavage (BAL) levels of inflammatory and remodeling mediators and of extra-cellular matrix (ECM) components will be measured after 6 months and 12 months of mepolizumab treatment. Relationship between clinical response to mepolizumab and remodeling changes after 6 months and 12 months will be assessed.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asthma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Mepolizumab
- description
- Patients receiving mepolizumab
- label
- Patients w/o mepolizumab (retrospective)
- description
- Retrospective control group of patients not exposed to mepolizumab, included in the COBRA cohort and the ASMATHERM protocol, who had 2 sets of biopsies and BAL within a 6 to 12 month-interval, without change in their treatment. Clinical data for this patients are available at inclusion and after 12 months.
Primary outcomes (8)
- measure
- Changes in reticular basement membrane (RBM) thickening
- timeFrame
- 0, 6 and 12 months
- description
- The absolute variation in RBM thickening (µm, morphometry measurement on bronchial biopsies) over 12 months is defined as the difference between month twelve and baseline (V1). The absolute variation in RBM thickening over 6 months is defined as the difference between month six and baseline (V1).
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * adult \>18 years, * severe uncontrolled asthma, defined as eosinophil blood count \>300/mm3 in the previous 12 months and at least 2 exacerbations in the previous 12 months or requiring oral steroids for more than half of the previous year, * indication for mepolizumab decided by an asthma specialist, * efficient contraception, for women of reproductive age Exclusion criteria : * pregnancy, * smokers or ex smokers \>10 pack/yr, * contra indication for fiberoptic bronchoscopy (allergy to xylocain, antiaggregant or anticoagulant treatment...), * contra indication for mepolizumab, * patient who previously received mepolizumab or already received mepolizumab at inclusion, * participation in another interventional trial
References
Publications (1)
- DERIVEDTaille C, Hamidi F, Heddebaut N, Pote N, Le Guen P, Le Brun M, Roy C, Dupont A, Letuve S. Impact of Mepolizumab on Airway Remodeling and Inflammation in Severe Eosinophilic Asthma. Chest. 2026 Apr;169(4):890-901. doi: 10.1016/j.chest.2025.10.047. Epub 2025 Dec 5. PMID 41354402