Efficacy of an anti-TSLP monoclonal antibody in the management of chronic bronchial disease induced by bronchiolitis obliterans syndrome in allogeneic hematopoietic stem cells transplantation recipients.

The medical condition studied in IMMUNO-BOS is Bronchiolitis obliterans syndrome (BOS) after allogeneic stem cell transplantation

The primary endpoint is the within-patient change in the annualized number of bronchial exacerbations between the 12-month period prior to treatment initiation and the 12-month treatment period. Bronchial exacerbations will be defined as acute bronchial symptoms lasting more than 48h and requiring hospitalization and/or anti infectious or corticosteroids.

Endpoints evaluating the improvement of respiratory symptoms and corticosteroids sparing (secondary objective n°1): Clinical outcomes: • Number of days alive and not exacerbating • Number of days alive and not hospitalized • Reduction in corticosteroids regimen (inhaled and/or systemic route) Outcomes from validated questionnaires: • ACQ6 score (Asthma Control Questionnaire 6) • Breathlessness, Cough and Sputum Scale (BCSS) • St George Respiratory Questionnaire (SGRQ), 2 Functionnal outcomes: • Pre-bronchodilator spirometry [forced expiratory volume in 1 second, forced vital capacity and the FEV1/FVC ratio. • Pre- bronchodilator plethysmography [total lung capacity, residual volume and the TLC/RV ratio] • Inspiratory and expiratory oscillometry parameters: resistance at 5 Hz, reactance at 5 Hz, Frequence of resonnance, Immunological outcomes: • Blood eosinophilia (absolute count, G/L) • Eosinophilia in induced sputum (relative count, %) • Blood total IgE count (kUI/L), Exhalomic outcomes Unsupervised analysis of VOCs in exhaled air of patients blowing in a quadrupole-time-of-flight mass spectrometer (PTR-Qi-TOF MS; Ionicon, Innsbruck, Austria). Identification of VOCs (peaks corresponding to m/z) significantly changing over the year of treatment and correlation with clinical and biological readouts.

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