Effect of Dupilumab an mucus plugs and inflammatory patterns in sEvere asThmAtiC paTients — a Pilot Study (DETACT)

Prior treatment

• experience of an asthma exacerbation within 4 weeks prior to the first main visit
• Low dose systemic corticosteroid therapy for asthma is allowed
• drug and/or alcohol abuse

Other illness

• Current smoker or former smoker if stopped smoking <6 months and/or has a smoking history of >10 pack years
• 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
• a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
• 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

Other

• pregnancy (positive ß-HCG test)
• severe anatomic variations or deviations that do not allow bronchoscopy
• clinically meaningful comorbidities

• ≥18 years of age
• a recorded clinical diagnosis of asthma (ICD-10 Code: J45)
• 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%
• 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