Effect of Dupilumab an mucus plugs and inflammatory patterns in sEvere asThmAtiC paTients — a Pilot Study (DETACT)
Key facts
- Where
- Vienna, AusztriaSee the site
- Phase
- 4. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Ausztria
- Medical University of ViennaVienna, AusztriaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University Of Vienna
- Trial code
- EU 2024-517567-23-00
- Record updated
- 2024. december 10.
- Original description
To evaluate the effect of Dupilumab on mucus plugging in the airways of patients suffering from severe asthmaRead full original descriptionShow less
To evaluate the effect of Dupilumab on mucus plugging in the airways of patients suffering from severe asthma
Inclusion: ≥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.
Exclusion: 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; 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; pregnancy (positive ß-HCG test); severe anatomic variations or deviations that do not allow bronchoscopy; clinically meaningful comorbidities.