Dupilumab for Severe asthma

Inclusion criteria

• {"criterion_text":"- ≥18 years of age\n- a recorded clinical diagnosis of asthma (ICD-10 Code: J45)\n- Meeting the Dupilumab treatment requirements for severe T2-high asthma: o FeNO > 25 ppB o had either twice 250 eosinophils /µl measured in the blood OR one measurement of blood eosinophils 250 cells/µl during reduction of OCS dosing if treated with oral corticosteroids o one measurement of sputum ≥ 2% or BAL eosinophils ≥ 1%\n- Patients with history of treatment with monoclonal antibodies for asthma or polyps will only be included if at least a wash out period of 2 half -lives or 1 months has passed"}

Exclusion criteria

• {"criterion_text":"- pregnancy (positive ß-HCG test)\n- Current smoker or former smoker if stopped smoking <6 months and/or has a smoking history of >10 pack years\n- severe anatomic variations or deviations that do not allow bronchoscopy\n- confounding lung disorders except asthma including: o chronic obstructive pulmonary disorder (COPD) and emphysema, pulmonary fibrosis o Cystic fibrosis, any known parasitic infections and lung cancer\n- a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study\n- clinically meaningful comorbidities\n- experience of an asthma exacerbation within 4 weeks prior to the first main visit\n- immune disorder and/or immunosuppressive treatment (e.g. cyclosporine), ongoing biological treatment of asthma (e.g., mepolizumab, omalizumab, benralizumab) or last biological treatment 2 half-lives or 1 month befor the first main visit\n- Low dose systemic corticosteroid therapy for asthma is allowed\n- drug and/or alcohol abuse"}

Primary endpoints

• {"endpoint_text":"- To evaluate the effect of Dupilumab on mucus plugging in the airways of patients suffering from severe asthma","definition_or_measurement_approach":""}

Other endpoints

• {"endpoint_text":"- are to evaluate the effect of Dupilumab treatment on: cellular composition and activation pattern of immune cells isolated from bronchoalveolar lavage (BAL)\n- inflammatory mediator concentrations in BAL supernatant\n- transcriptional expression profile in BAL cells and lung tissue\n- composition of the lung microbiome in BAL\n- characteristics of the metabolom in BAL\n- blood eosinophils\n- FeNO-values over the course of this study\n- Lung function over the course of this study","definition_or_measurement_approach":""}

Austria

Earliest CTIS Part Ii Submission Date

28-10-2024

Latest Decision Or Authorization Date

10-12-2024

Processing Time Days

43

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria